Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-01 @ 5:44 AM
Study NCT ID:
NCT04556656
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2020-09-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD
Sponsor:
Organization:
Raw JSON
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Results can be used by the institution for (a) internal noncommercial research, education and patient care, and (b) as required under applicable laws and regulations. Other uses require prior written consent of the sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule', 'otherNumAtRisk': 250, 'deathsNumAtRisk': 250, 'otherNumAffected': 204, 'seriousNumAtRisk': 250, 'deathsNumAffected': 4, 'seriousNumAffected': 34}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule', 'otherNumAtRisk': 249, 'deathsNumAtRisk': 249, 'otherNumAffected': 212, 'seriousNumAtRisk': 249, 'deathsNumAffected': 1, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Microcytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Unified Huntington Disease Rating Scale-Total Functional Capacity (UHDRS-TFC) Score (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.18', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '0.119', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1670', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.162', 'groupDescription': 'In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 65', 'description': 'The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \\[domestic chores, activities of daily living, finances, care level, and occupation\\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent to treat (mITT) population included all participants in the ITT population who received at least one dose of study drug and had valid in clinic TFC scores both at baseline and at least one post-baseline timepoint. The mITT population was analyzed according to the treatment to which the participant was randomized.\n\nThe mITT population was the main analysis population for the primary endpoint in non-EMA regions. Note that the analysis was based on observed data.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 65 in the UHDRS TFC Score (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.17', 'spread': '0.120', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '0.120', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1598', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.162', 'groupDescription': 'In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 65.', 'description': 'The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \\[domestic chores, activities of daily living, finances, care level, and occupation\\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent to treat (ITT) population included all randomized participants. The ITT population was analyzed according to the treatment to which the participant was randomized.\n\nThe ITT population was the main analysis population for the primary endpoint in the EMA region.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 65 in Composite UHDRS (cUHDRS) Total Score (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.109', 'groupId': 'OG000'}, {'value': '-0.88', 'spread': '0.108', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4544', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.148', 'groupDescription': 'In the MMRM, change in cUHDRS score from baseline was the dependent variable, while independent variables included treatment arm, baseline cUHDRS, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 65', 'description': 'The composite Unified Huntington Disease Rating Scale (cUHDRS) uses 4 components:\n\nTotal Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Higher score = worse outcome. Best score=0. Worst score= 124.\n\nStroop Word Reading (SWR) measures attention and mental flexibility. Pat. reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome. Best score=100. Worst score=0.\n\nSymbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to match numbers with symbols. Scores = correct answers in 90 sec. Higher score = better outcome. Best score=120. Worst score=0.\n\nTotal Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. Higher score = better outcome. Best score=13. Worst score=0.\n\nTotal integrated cUHDRS scale range: -7.6 to 24.8. The higher, the better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent to treat (mITT) population included all participants in the ITT population who received at least one dose of study drug and had valid in-clinic TFC scores both at baseline and at least one post-baseline timepoint. The mITT population was analyzed according to the treatment to which the participant was randomized. Note that the analysis was based on as observed data only, patient numbers are therefore lower.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.114', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.108', 'groupId': 'OG001'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.125', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.135', 'groupId': 'OG001'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.137', 'groupId': 'OG001'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.159', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.158', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.156', 'groupDescription': 'From baseline to Week 26.\n\nIn the MMRM model, change in cUHDRS score from baseline was the dependent variable and independent variables included treatment group, baseline cUHDRS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0135', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.179', 'groupDescription': 'From baseline to Week 39', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0351', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.193', 'groupDescription': 'From baseline to Week 52', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1683', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.197', 'groupDescription': 'From baseline to Week 65.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5315', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.223', 'groupDescription': 'From baseline to Week 78', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78', 'description': 'The composite Unified Huntington Disease Rating Scale (cUHDRS) assesses 4 components (see secondary outcome for details):\n\nTotal Motor Score (TMS) for motor features. Higher score = worse outcome. Worst = 124.\n\nStroop Word Reading (SWR) measures attention and mental flexibility. Higher score = better outcome.\n\nSymbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Higher score = better outcome.\n\nTotal Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. The higher, the better.\n\nTotal cUHDRS scale range: -7.6 to 24.8 (assuming 150 as the max score of SWR). The higher, the better.\n\nThis sensitivity analysis was performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.85', 'spread': '6.846', 'groupId': 'OG000'}, {'value': '6.30', 'spread': '6.449', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.37', 'spread': '7.135', 'groupId': 'OG000'}, {'value': '11.95', 'spread': '6.792', 'groupId': 'OG001'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'spread': '7.365', 'groupId': 'OG000'}, {'value': '23.93', 'spread': '7.028', 'groupId': 'OG001'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.46', 'spread': '7.444', 'groupId': 'OG000'}, {'value': '24.36', 'spread': '7.230', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0253', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.15', 'ciLowerLimit': '-39.66', 'ciUpperLimit': '-2.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.406', 'estimateComment': 'Negative change = improvement.', 'groupDescription': 'From baseline to Week 26. In the MMRM model, change in Q-Motor Finger Tapping IOI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Finger Tapping IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1474', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.31', 'ciLowerLimit': '-33.71', 'ciUpperLimit': '5.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.853', 'groupDescription': 'From baseline to Week 52.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0159', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.71', 'ciLowerLimit': '-44.76', 'ciUpperLimit': '-4.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.185', 'groupDescription': 'From baseline to Week 65.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0283', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.90', 'ciLowerLimit': '-43.34', 'ciUpperLimit': '-2.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.380', 'groupDescription': 'From baseline to Week 78.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time course from baseline to Week 26, Week 52, Week 65, and Week 78.', 'description': 'Quantitative (Q)-motor is a clinical assessment of fine motor skills. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. The index finger is positioned above a force transducer and is to tap as fast as possible. The start was defined as a rise of the force by 0.05 Newton above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. The IOI refers to the time between the onset of consecutive taps (the faster, the better).\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.', 'unitOfMeasure': 'milliseconds (decrease = improvement)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.63', 'spread': '8.029', 'groupId': 'OG000'}, {'value': '20.43', 'spread': '7.448', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '9.124', 'groupId': 'OG000'}, {'value': '20.07', 'spread': '8.555', 'groupId': 'OG001'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.64', 'spread': '8.380', 'groupId': 'OG000'}, {'value': '28.55', 'spread': '7.867', 'groupId': 'OG001'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.73', 'spread': '9.740', 'groupId': 'OG000'}, {'value': '34.97', 'spread': '9.412', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.06', 'ciLowerLimit': '-59.74', 'ciUpperLimit': '-16.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.999', 'groupDescription': 'From baseline to Week 26. In MMRM model, change in Q-Motor Pronation/Supination ITI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Q-Motor Pronation/Supination ITI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.21', 'ciLowerLimit': '-44.95', 'ciUpperLimit': '4.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.547', 'groupDescription': 'From baseline to Week 52.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0395', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.92', 'ciLowerLimit': '-46.68', 'ciUpperLimit': '-1.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.541', 'groupDescription': 'From baseline to Week 65.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.23', 'ciLowerLimit': '-49.08', 'ciUpperLimit': '4.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.587', 'groupDescription': 'From baseline to Week 78.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time course from baseline to Week 26, Week 52, Week 65, and Week 78.', 'description': 'Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Pronation/Supination assesses the regularity of hand taps. The force and duration of the hand taps were recorded similarly to the speeded tapping task. One pronation/supination hand tapping measure is ITI (the faster, the better).\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.70', 'spread': '9.399', 'groupId': 'OG000'}, {'value': '13.68', 'spread': '8.829', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.40', 'spread': '10.978', 'groupId': 'OG000'}, {'value': '24.23', 'spread': '10.467', 'groupId': 'OG001'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.34', 'spread': '10.730', 'groupId': 'OG000'}, {'value': '30.13', 'spread': '10.232', 'groupId': 'OG001'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.21', 'spread': '12.702', 'groupId': 'OG000'}, {'value': '41.93', 'spread': '12.435', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.38', 'ciLowerLimit': '-55.78', 'ciUpperLimit': '-4.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.902', 'groupDescription': 'From baseline to Week 26. In the MMRM model, change in Pronation/Supination IOI Mean from BL was the dependent variable and independent variables included treatment group, BL Pronation/Supination IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), treatment by categorical week interaction, conc. use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2680', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.84', 'ciLowerLimit': '-46.69', 'ciUpperLimit': '13.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.170', 'groupDescription': 'From baseline to Week 52.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1255', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.79', 'ciLowerLimit': '-51.97', 'ciUpperLimit': '6.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.829', 'groupDescription': 'From baseline to Week 65.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.72', 'ciLowerLimit': '-57.72', 'ciUpperLimit': '12.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.777', 'groupDescription': 'From baseline to Week 78.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time course from baseline to Week 26, Week 52, Week 65, and Week 78.', 'description': 'Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Pronation/Supination assess the regularity of hand taps. The force and duration of the hand taps were recorded similarly to the speeded tapping task. One pronation/supination hand tapping measure is IOI (the faster, the better).\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.131', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.124', 'groupId': 'OG001'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.137', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.131', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.149', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.143', 'groupId': 'OG001'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.156', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.150', 'groupId': 'OG001'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.166', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.163', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.179', 'groupDescription': 'From baseline to Week 26.\n\nIn the MMRM model, change in UHDRS-TFC score from baseline was the dependent variable and independent variables included treatment group, Baseline UHDRS-TFC, region, categorical week, Baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2991', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.188', 'groupDescription': 'From baseline to Week 39.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.205', 'groupDescription': 'From baseline to Week 52.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8242', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.215', 'groupDescription': 'From baseline to Week 65.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5918', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.231', 'groupDescription': 'From baseline to Week 78.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78', 'description': 'Total Functional Capacity (TFC) tests the capacity to maintain domestic chores, activities of daily living, finances, care level, and occupation. Scores from 0 - 13. Higher score = better outcome.\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.34', 'spread': '0.964', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.916', 'groupId': 'OG001'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.85', 'spread': '1.100', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '1.051', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.73', 'spread': '1.078', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '1.039', 'groupId': 'OG001'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.39', 'spread': '1.243', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '1.193', 'groupId': 'OG001'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.91', 'spread': '1.261', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '1.249', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0178', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.16', 'ciLowerLimit': '0.55', 'ciUpperLimit': '5.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.326', 'groupDescription': 'From baseline to Week 26. In the MMRM model, change in SWR score from baseline was the dependent variable and independent variables included treatment group, baseline SWR, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0576', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.89', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '5.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.518', 'groupDescription': 'From baseline to Week 39.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0418', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.05', 'ciLowerLimit': '0.11', 'ciUpperLimit': '5.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.493', 'groupDescription': 'From baseline to Week 52.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1775', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.32', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '5.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.719', 'groupDescription': 'From baseline to Week 65.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.99', 'ciLowerLimit': '-1.50', 'ciUpperLimit': '5.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.772', 'groupDescription': 'From baseline to Week 78.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78', 'description': 'Stroop Word Reading (SWR) measures attention and mental flexibility. Pat. reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome.\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.521', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.484', 'groupId': 'OG001'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.512', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.478', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.578', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.543', 'groupId': 'OG001'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.616', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.576', 'groupId': 'OG001'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.617', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.598', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1586', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '2.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.712', 'groupDescription': 'From baseline to Week 26. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2144', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '2.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.701', 'groupDescription': 'From baseline to Week 39. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9119', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '1.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.793', 'groupDescription': 'From baseline to Week 52. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7339', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '1.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.844', 'groupDescription': 'From baseline to Week 65. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '2.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.859', 'groupDescription': 'From baseline to Week 78. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78.', 'description': 'Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to write match numbers with symbols. Scoring sums correct substitutions in 90 second interval (max = 110). Higher score = better outcome.\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.568', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.530', 'groupId': 'OG001'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.780', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '0.729', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.766', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.720', 'groupId': 'OG001'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.847', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '0.790', 'groupId': 'OG001'}]}]}, {'title': 'Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.19', 'spread': '0.954', 'groupId': 'OG000'}, {'value': '1.63', 'spread': '0.916', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8205', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-1.71', 'ciUpperLimit': '1.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.777', 'groupDescription': 'From baseline to Week 26. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '1.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.067', 'groupDescription': 'From baseline to Week 39. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '1.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.051', 'groupDescription': 'From baseline to Week 52. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7605', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-2.64', 'ciUpperLimit': '1.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.158', 'groupDescription': 'From baseline to Week 65. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6694', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '-2.05', 'ciUpperLimit': '3.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.323', 'groupDescription': 'From baseline to Week 78. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78.', 'description': 'Total Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Each rated 0 (normal) - 4 (abnormal). Higher score = worse outcome. Worst = 124.\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '249'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '227'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Not further specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)\n\nPridopidine: Pridopidine hard gelatin capsule'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo\n\nPlacebo: Pridopidine-matching placebo hard gelatin capsule'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '11.93', 'groupId': 'BG000'}, {'value': '52.7', 'spread': '11.39', 'groupId': 'BG001'}, {'value': '52.5', 'spread': '11.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '242', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HD stage at randomization', 'classes': [{'categories': [{'title': 'HD1', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}, {'title': 'HD2', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-10', 'size': 2079580, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-13T05:20', 'hasProtocol': True}, {'date': '2023-03-28', 'size': 2191945, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-13T05:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 499}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2020-09-14', 'resultsFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-21', 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT)', 'timeFrame': 'Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78', 'description': 'The composite Unified Huntington Disease Rating Scale (cUHDRS) assesses 4 components (see secondary outcome for details):\n\nTotal Motor Score (TMS) for motor features. Higher score = worse outcome. Worst = 124.\n\nStroop Word Reading (SWR) measures attention and mental flexibility. Higher score = better outcome.\n\nSymbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Higher score = better outcome.\n\nTotal Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. The higher, the better.\n\nTotal cUHDRS scale range: -7.6 to 24.8 (assuming 150 as the max score of SWR). The higher, the better.\n\nThis sensitivity analysis was performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.'}, {'measure': 'Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT)', 'timeFrame': 'Time course from baseline to Week 26, Week 52, Week 65, and Week 78.', 'description': 'Quantitative (Q)-motor is a clinical assessment of fine motor skills. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. The index finger is positioned above a force transducer and is to tap as fast as possible. The start was defined as a rise of the force by 0.05 Newton above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. The IOI refers to the time between the onset of consecutive taps (the faster, the better).\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.'}, {'measure': 'Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT)', 'timeFrame': 'Time course from baseline to Week 26, Week 52, Week 65, and Week 78.', 'description': 'Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Pronation/Supination assesses the regularity of hand taps. The force and duration of the hand taps were recorded similarly to the speeded tapping task. One pronation/supination hand tapping measure is ITI (the faster, the better).\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.'}, {'measure': 'Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT)', 'timeFrame': 'Time course from baseline to Week 26, Week 52, Week 65, and Week 78.', 'description': 'Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Pronation/Supination assess the regularity of hand taps. The force and duration of the hand taps were recorded similarly to the speeded tapping task. One pronation/supination hand tapping measure is IOI (the faster, the better).\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.'}, {'measure': 'Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT)', 'timeFrame': 'Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78', 'description': 'Total Functional Capacity (TFC) tests the capacity to maintain domestic chores, activities of daily living, finances, care level, and occupation. Scores from 0 - 13. Higher score = better outcome.\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.'}, {'measure': 'Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT)', 'timeFrame': 'Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78', 'description': 'Stroop Word Reading (SWR) measures attention and mental flexibility. Pat. reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome.\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.'}, {'measure': 'Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT)', 'timeFrame': 'Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78.', 'description': 'Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to write match numbers with symbols. Scoring sums correct substitutions in 90 second interval (max = 110). Higher score = better outcome.\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.'}, {'measure': 'Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT)', 'timeFrame': 'Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78.', 'description': 'Total Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Each rated 0 (normal) - 4 (abnormal). Higher score = worse outcome. Worst = 124.\n\nIn addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in the Unified Huntington Disease Rating Scale-Total Functional Capacity (UHDRS-TFC) Score (mITT)', 'timeFrame': 'From baseline to Week 65', 'description': 'The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \\[domestic chores, activities of daily living, finances, care level, and occupation\\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity.'}, {'measure': 'Change From Baseline to Week 65 in the UHDRS TFC Score (ITT)', 'timeFrame': 'From baseline to Week 65.', 'description': 'The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \\[domestic chores, activities of daily living, finances, care level, and occupation\\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 65 in Composite UHDRS (cUHDRS) Total Score (mITT)', 'timeFrame': 'From baseline to Week 65', 'description': 'The composite Unified Huntington Disease Rating Scale (cUHDRS) uses 4 components:\n\nTotal Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Higher score = worse outcome. Best score=0. Worst score= 124.\n\nStroop Word Reading (SWR) measures attention and mental flexibility. Pat. reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome. Best score=100. Worst score=0.\n\nSymbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to match numbers with symbols. Scores = correct answers in 90 sec. Higher score = better outcome. Best score=120. Worst score=0.\n\nTotal Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. Higher score = better outcome. Best score=13. Worst score=0.\n\nTotal integrated cUHDRS scale range: -7.6 to 24.8. The higher, the better.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Huntington Disease'], 'conditions': ['Huntington Disease']}, 'referencesModule': {'references': [{'pmid': '40913168', 'type': 'DERIVED', 'citation': "Reilmann R, Feigin A, Rosser AE, Kostyk SK, Saft C, Cohen Y, Schuring H, Hand R, Tan AM, Chen K, Feng W, Navon-Perry L, Cruz-Herranz A, Syltevik C, Boot D, Squitieri F, Kayson E, Mehra M, Goldberg YP, Geva M, Hayden MR; PROOF-HD study investigators. Pridopidine in early-stage manifest Huntington's disease: a phase 3 trial. Nat Med. 2025 Nov;31(11):3780-3789. doi: 10.1038/s41591-025-03920-3. Epub 2025 Sep 5."}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).', 'detailedDescription': 'This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pridopidine 45 mg BID in patients with early stage HD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA MAIN STUDY\n\n1. Diagnosis of HD based on clinical features and the presence of ≥36 CAG repeats in the huntingtin gene\n2. Diagnostic confidence level (DCL) of 4\n3. Adult-onset HD with onset of signs and symptoms ≥18 years of age\n4. Stage 1 or Stage 2 HD, defined as a UHDRS-TFC score of ≥7, at screening\n\nEXCLUSION CRITERIA\n\n1. Use of pridopidine within 12 months before the baseline visit.\n2. Gene therapy at any time\n3. Any serious medical condition or clinically significant laboratory, or vital sign abnormality that precludes the patient's safe participation in and completion of the study e.g. significant heart disease within 12 weeks before baseline or history of certain cardiac arrhythmias\n4. History of epilepsy or seizures within the last 5 years\n5. Pregnant or breastfeeding, or intention to become pregnant during the study"}, 'identificationModule': {'nctId': 'NCT04556656', 'briefTitle': "PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD", 'organization': {'class': 'INDUSTRY', 'fullName': 'Prilenia'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington Disease', 'orgStudyIdInfo': {'id': 'PL101-HD301'}, 'secondaryIdInfos': [{'id': '2020-002822-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pridopidine', 'description': '45 mg pridopidine twice daily (BID)', 'interventionNames': ['Drug: Pridopidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pridopidine', 'type': 'DRUG', 'description': 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