Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT03624920
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2018-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'werner.rein@theranexus.fr', 'phone': '+33680026779', 'title': 'Chief Medical Officer', 'organization': 'Theranexus'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.', 'description': 'Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit', 'eventGroups': [{'id': 'EG000', 'title': 'THN102 Placebo', 'description': 'THN102 Placebo (Dosage A)', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 3, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'THN102 200/2', 'description': 'THN102 200 mg/2 mg (Dosage B)', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 10, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'THN102 200/18', 'description': 'THN102 200 mg/18 mg (Dosage C)', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 22, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Muscle spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'CONTUSION', 'notes': 'wrist contusion and low back pain after fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'THN102 Placebo (Dosage A)'}, {'id': 'OG001', 'title': 'THN102 200/2', 'description': 'THN102 200 mg/2 mg (Dosage B)'}, {'id': 'OG002', 'title': 'THN102 200/18', 'description': 'THN102 200 mg/18 mg (Dosage C)'}], 'classes': [{'title': 'Subjects with at least one TEAE leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subject with at least one serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one related serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one TEAE', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one related TEAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one TEAE leading to discont', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one related TEAE leading to', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one serious TEAE leading to', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'Number of participants with spontaneously reported treatment-related adverse events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participant reported corresponds to the safety set population of the clinical report'}, {'type': 'SECONDARY', 'title': 'Epworth Sleeping Scale (ESS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'THN102 Placebo (Dosage A)'}, {'id': 'OG001', 'title': 'THN102 200/2', 'description': 'THN102 200 mg/2 mg (Dosage B)'}, {'id': 'OG002', 'title': 'THN102 200/18', 'description': 'THN102 200 mg/18 mg (Dosage C)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4422', 'spread': '0.5117', 'groupId': 'OG000'}, {'value': '-3.8417', 'spread': '0.5086', 'groupId': 'OG001'}, {'value': '-3.1850', 'spread': '0.4982', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Range of the scale : 0 to 24. A low score indicates a good outcome. Results shown are corresponding to a change from baseline of the ESS score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat'}, {'type': 'SECONDARY', 'title': 'Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'THN102 Placebo (Dosage A)'}, {'id': 'OG001', 'title': 'THN102 200/2', 'description': 'THN102 200 mg/2 mg (Dosage B)'}, {'id': 'OG002', 'title': 'THN102 200/18', 'description': 'THN102 200 mg/18 mg (Dosage C)'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.2201', 'spread': '10.0565', 'groupId': 'OG000'}, {'value': '-24.1089', 'spread': '9.9393', 'groupId': 'OG001'}, {'value': '-19.6450', 'spread': '9.8847', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'PVT measures reaction time in milliseconds. The results below are corresponding to the reaction time change from baseline.', 'unitOfMeasure': 'millisecond (msec)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PVT full analysis set'}, {'type': 'SECONDARY', 'title': 'Montreal Cognitive Assessment Battery (MoCA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'THN102 Placebo (Dosage A)'}, {'id': 'OG001', 'title': 'THN102 200/2', 'description': 'THN102 200 mg/2 mg (Dosage B)'}, {'id': 'OG002', 'title': 'THN102 200/18', 'description': 'THN102 200 mg/18 mg (Dosage C)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2240', 'spread': '0.1935', 'groupId': 'OG000'}, {'value': '0.03267', 'spread': '0.1923', 'groupId': 'OG001'}, {'value': '0.4251', 'spread': '0.1900', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'MoCA score reflects the cognitive capacities of a person. Range of the total score of 10 test items: 0 to 30 points. A high score indicates good cognitive functioning. A score of 26 and above is considered normal.\n\nThe results below are shown as change from baseline of the MoCA score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'THN102 Placebo (Dosage A)'}, {'id': 'OG001', 'title': 'THN102 200/2', 'description': 'THN102 200 mg/2 mg (Dosage B)'}, {'id': 'OG002', 'title': 'THN102 200/18', 'description': 'THN102 200 mg/18 mg (Dosage C)'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks', 'description': 'ESS score responder rate, defined as the proportion of subjects with at least 25% ESS improvement from baseline, at the end of each treatment period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'THN102 Placebo (Dosage A)'}, {'id': 'OG001', 'title': 'THN102 200/2', 'description': 'THN102 200 mg/2 mg (Dosage B)'}, {'id': 'OG002', 'title': 'THN102 200/18', 'description': 'THN102 200 mg/18 mg (Dosage C)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks', 'description': 'Number of patients in remission (=without residual sleepiness), i.e. ESS \\< 11 at the end of each treatment period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence ABC', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}, {'id': 'FG001', 'title': 'Sequence BCA', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}, {'id': 'FG002', 'title': 'Sequence CAB', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}, {'id': 'FG003', 'title': 'Sequence ACB', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}, {'id': 'FG004', 'title': 'Sequence CBA', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}, {'id': 'FG005', 'title': 'Sequence BAC', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '105 patients were screened and 77 were randomized and allowed to start the medications periods.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence ABC', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}, {'id': 'BG001', 'title': 'Sequence BCA', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}, {'id': 'BG002', 'title': 'Sequence CAB', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}, {'id': 'BG003', 'title': 'Sequence ACB', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}, {'id': 'BG004', 'title': 'Sequence CBA', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}, {'id': 'BG005', 'title': 'Sequence BAC', 'description': 'A : 2 weeks under Placebo\n\nB : 2 weeks under THN102 200/2 (200mg modafinil and 2 mg of flecainide per os daily)\n\nC : 2 weeks under THN102 200/18 (200mg modafinil and 18 mg of flecainide per os daily)'}, {'id': 'BG006', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race : White', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}]}]}, {'title': 'Race Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Ethnicity : Not hispanic or latino', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '69', 'groupId': 'BG006'}]}]}, {'title': 'Ethnicity : Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Ethnicity : not reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'mITT'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-27', 'size': 1888432, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-15T05:17', 'hasProtocol': True}, {'date': '2020-02-21', 'size': 2234128, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-15T05:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Complete 3 way-Crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-27', 'studyFirstSubmitDate': '2018-07-10', 'resultsFirstSubmitDate': '2020-09-27', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-27', 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Adverse Events', 'timeFrame': '2 weeks', 'description': 'Number of participants with spontaneously reported treatment-related adverse events'}], 'secondaryOutcomes': [{'measure': 'Epworth Sleeping Scale (ESS)', 'timeFrame': '2 weeks', 'description': 'Range of the scale : 0 to 24. A low score indicates a good outcome. Results shown are corresponding to a change from baseline of the ESS score.'}, {'measure': 'Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline', 'timeFrame': '2 weeks', 'description': 'PVT measures reaction time in milliseconds. The results below are corresponding to the reaction time change from baseline.'}, {'measure': 'Montreal Cognitive Assessment Battery (MoCA)', 'timeFrame': '2 weeks', 'description': 'MoCA score reflects the cognitive capacities of a person. Range of the total score of 10 test items: 0 to 30 points. A high score indicates good cognitive functioning. A score of 26 and above is considered normal.\n\nThe results below are shown as change from baseline of the MoCA score.'}, {'measure': 'Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'ESS score responder rate, defined as the proportion of subjects with at least 25% ESS improvement from baseline, at the end of each treatment period'}, {'measure': 'Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline', 'timeFrame': '2 weeks', 'description': 'Number of patients in remission (=without residual sleepiness), i.e. ESS \\< 11 at the end of each treatment period'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.", 'detailedDescription': 'The treatment duration is 2 weeks per period. Each treatment period is followed by a one-week washout period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with a diagnosis of idiopathic Parkinson's disease as defined by the Movement Disorders Society (MDS).\n* Subjects with Hoehn and Yahr scale score ≤ 4.\n* Body mass index \\> 18 kg/m2 and \\< 35 kg/m2.\n* Subjects should have a complaint of daytime sleepiness impacting their quality of life and/or daytime functioning (e.g. falling asleep while reading or watching television, while eating or talking with other people).\n* Epworth Sleepiness Scale (ESS) score ≥ 14.\n\nExclusion Criteria:\n\n* Subjects with known or with a suspected sleep apnea syndrome or who have any other cause of excessive daytime sleepiness, such as shift work sleep disorder.\n* Psychiatric and neurological disorders (other than Parkinson's disease),\n* Cardiovascular disorders such as - but not limited to\n* Uncontrolled moderate to severe hypertension\n* History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study\n* Recent myocardial infarction\n* Stable or unstable angina pectoris\n* Cardiac insufficiency or history of heart failure\n* Previous history of cardiac valvular surgery\n* Subjects with current impulse control disorder.\n* Subjects showing dementia or with MoCA \\< 23.\n* Subjects with current suicidal risk\n* Current or recent (within one year) history of substance abuse or dependence disorder\n* Other active clinically significant illness\n* Subjects with hepatic or renal impairment"}, 'identificationModule': {'nctId': 'NCT03624920', 'briefTitle': "Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness", 'organization': {'class': 'INDUSTRY', 'fullName': 'Theranexus'}, 'officialTitle': "Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness", 'orgStudyIdInfo': {'id': 'THN102-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'THN102 Dosage A', 'description': 'THN102 Dosage A is a Placebo', 'interventionNames': ['Drug: THN102 Dosage A']}, {'type': 'EXPERIMENTAL', 'label': 'THN102 Dosage B', 'description': 'THN102 Dosage B : 200 mg/2 mg THN102 is a combination of modafinil 100mg and flecainide 1 mg daily dosage is 200 mg of modafinil and 2 mg of flecainide', 'interventionNames': ['Drug: THN102 Dosage B']}, {'type': 'EXPERIMENTAL', 'label': 'THN102 Dosage C', 'description': 'THN102 Dosage C : 200 mg/18 mg THN102 is a combination of modafinil 100mg and flecainide 9 mg daily dosage is 200 mg of modafinil and 18 mg of flecainide', 'interventionNames': ['Drug: THN102 Dosage C']}], 'interventions': [{'name': 'THN102 Dosage A', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'THN102 Dosages A: placebo', 'armGroupLabels': ['THN102 Dosage A']}, {'name': 'THN102 Dosage B', 'type': 'DRUG', 'otherNames': ['Dosage B'], 'description': 'THN102 Dosage B : 200mg/2mg', 'armGroupLabels': ['THN102 Dosage B']}, {'name': 'THN102 Dosage C', 'type': 'DRUG', 'otherNames': ['Dosage C'], 'description': 'THN102 Dosage C: 200mg/18mg', 'armGroupLabels': ['THN102 Dosage C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MGH Neurological Clinical Research Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 'facility': 'I. neurologická klinika Fakultní nemocnice u sv. 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