Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-04-23 @ 11:04 PM
Study NCT ID:
NCT02788357
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2016-05-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-stroke Neural Plasticity With Atomoxetine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lsawa2@uky.edu', 'title': 'Dr. Lumy Sawaki', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Atomoxetine With Motor Training', 'description': '40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays\n\nAtomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo With Motor Training', 'description': 'Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays\n\nPlacebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Fugl Meyer Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine With Motor Training', 'description': '40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays\n\nAtomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}, {'id': 'OG001', 'title': 'Placebo With Motor Training', 'description': 'Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays\n\nPlacebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}], 'classes': [{'title': 'Post-intervention minus baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '13.2'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '6.1'}]}]}, {'title': '1-month follow-up minus baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '17.9'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '10.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': 'Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects in Atomoxetine group were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Action Arm Research Test (ARAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine With Motor Training', 'description': '40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays\n\nAtomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}, {'id': 'OG001', 'title': 'Placebo With Motor Training', 'description': 'Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays\n\nPlacebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}], 'classes': [{'title': 'Post-intervention minus baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '10.7'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '8.4'}]}]}, {'title': '1-month follow-up minus baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '15.1'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '10.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': 'Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The score is calculated by summing the scores for 19 individual tasks. The possible scores range from 0 to 57, with higher scores indicating better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects in the Atomoxetine group were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Wolf Motor Function Test (WMFT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine With Motor Training', 'description': '40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays\n\nAtomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}, {'id': 'OG001', 'title': 'Placebo With Motor Training', 'description': 'Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays\n\nPlacebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}], 'classes': [{'title': 'Post-intervention minus baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.26', 'upperLimit': '0.06'}, {'value': '-0.19', 'groupId': 'OG001', 'lowerLimit': '-0.35', 'upperLimit': '-0.03'}]}]}, {'title': '1-month follow-up minus baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '0.06'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.37', 'upperLimit': '-0.04'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': 'Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.', 'unitOfMeasure': 'log(seconds)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects in the Atomoxetine group were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Transcranial Magnetic Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine With Motor Training', 'description': '40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays\n\nAtomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}, {'id': 'OG001', 'title': 'Placebo With Motor Training', 'description': 'Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays\n\nPlacebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}], 'timeFrame': 'Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline', 'reportingStatus': 'POSTED', 'populationDescription': 'This data is not available at this time, as a relocation occurred during the project. Data collected at the previous institution used different software and stored the data in a different format than is currently used. Therefore, reconciliation of this data is being attempted at this time.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atomoxetine With Motor Training', 'description': '40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays\n\nAtomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}, {'id': 'FG001', 'title': 'Placebo With Motor Training', 'description': 'Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays\n\nPlacebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atomoxetine With Motor Training', 'description': '40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays\n\nAtomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}, {'id': 'BG001', 'title': 'Placebo With Motor Training', 'description': 'Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays\n\nPlacebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-13', 'studyFirstSubmitDate': '2016-05-27', 'resultsFirstSubmitDate': '2017-06-15', 'studyFirstSubmitQcDate': '2016-06-01', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-13', 'studyFirstPostDateStruct': {'date': '2016-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Fugl Meyer Assessment', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': 'Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.'}], 'secondaryOutcomes': [{'measure': 'Change in Action Arm Research Test (ARAT)', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': 'Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The score is calculated by summing the scores for 19 individual tasks. The possible scores range from 0 to 57, with higher scores indicating better performance.'}, {'measure': 'Change in Wolf Motor Function Test (WMFT)', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': 'Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.'}, {'measure': 'Transcranial Magnetic Stimulation', 'timeFrame': 'Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['motor training', 'motor recovery', 'human', 'neuroplasticity', 'transcranial magnetic stimulation'], 'conditions': ['Atomoxetine Hydrochloride', 'Placebos']}, 'referencesModule': {'references': [{'pmid': '27858723', 'type': 'DERIVED', 'citation': 'Ward A, Carrico C, Powell E, Westgate PM, Nichols L, Fleischer A, Sawaki L. Safety and improvement of movement function after stroke with atomoxetine: A pilot randomized trial. Restor Neurol Neurosci. 2017;35(1):1-10. doi: 10.3233/RNN-160673.'}]}, 'descriptionModule': {'briefSummary': 'This proposal evaluates the safety and effectiveness of a noradrenergic drug named atomoxetine combined with motor training to enhance cortical plasticity and improve hand function after stroke.', 'detailedDescription': 'Extensive studies in laboratory animals and humans over the last ten years indicate that some medications, especially amphetamine, given with specific physical therapy may improve motor learning (and therefore recovery from stroke) more than physical therapy alone. However, the number of patients in clinical trials who have received physical therapy and amphetamine is very small, for two reasons: because amphetamine may interact with many other medications that stroke patients are already taking, and because its potential for addiction precludes its use on a daily basis. The investigators now wish to evaluate the effectiveness of a more selective medication, atomoxetine, known to have many fewer side effects and no potential for drug addiction. The proposed mechanism by which amphetamine enhances recovery is by increasing central levels of norepinephrine. While the investigators already know that this drug is more selective than amphetamine, the investigators would like to evaluate its effects on hand motor learning and motor recovery in chronic stroke patients in a clinical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic stroke patients\n* Single stroke\n* Chronic (more than 6 months after from stroke)\n* At least 21 years old, but there is no upper age range for this project.\n* Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.\n\nExclusion Criteria:\n\n* History of head injury with loss of consciousness\n* History of severe alcohol or drug abuse\n* History of psychiatric illness\n* Unstable cardiac dysrhythmia\n* High blood pressure (systolic pressure \\>160 mm Hg and/or diastolic pressure \\>100 mm Hg)\n* History of myocardial infarction or unstable angina\n* Pregnancy\n* Glaucoma, history of hypersensitivity or idiosyncrasy to sympathomimetic drugs.\n* Subjects using drugs suspected of interfering with plasticity, such as MAOI, alpha-adrenergic antagonists, benzodiazepines, muscarinic receptor antagonists, dopaminergic antagonists, or other neuroleptics within 3 months of recruitment.'}, 'identificationModule': {'nctId': 'NCT02788357', 'briefTitle': 'Post-stroke Neural Plasticity With Atomoxetine', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Enhancement of Post-stroke Neural Plasticity With Atomoxetine: a Pilot Study', 'orgStudyIdInfo': {'id': 'No ID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atomoxetine with motor training', 'description': '40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays', 'interventionNames': ['Drug: Atomoxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo with motor training', 'description': 'Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atomoxetine', 'type': 'DRUG', 'otherNames': ['Strattera'], 'description': 'Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.', 'armGroupLabels': ['Atomoxetine with motor training']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sham'], 'description': 'Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.', 'armGroupLabels': ['Placebo with motor training']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lumy Sawaki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Lumy Sawaki', 'investigatorAffiliation': 'University of Kentucky'}}}}