Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-03-02 @ 5:01 PM
Study NCT ID:
NCT01652534
Status:
TERMINATED
Last Update Posted:
2019-11-13
First Post:
2011-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tsimuni@nm.org', 'phone': '312-503-2970', 'title': 'Dr. Tanya Simuni', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Amantadine', 'description': 'Participants during Amantadine 100 mg tablet orally once a day for one week, then two tablets orally twice a day for one week.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants during Placebo tablet (matching Amantadine 100 mg tablet)', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Timed Up and Go (TUG) - ON Usual Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar Pill\n\nPlacebo: Sugar Pill'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '15.86', 'upperLimit': '18.16'}, {'value': '17.4', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '17.4'}]}]}, {'title': 'Change at 4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '1.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, change at 4 weeks', 'description': 'This is a walking assessment. The subject will begin in the seated position, stand up, walk 7 meters, turn around, and sit back down. The entire process from leaving the chair to returning to the chair will be timed. Also, the Timed Up and Go (TUG) will be done both in the ON and OFF states.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who could complete the task. Note: for the 2 participants who were tested while on placebo, one did not complete baseline, and one did not complete week 4, so a change could not be computed.'}, {'type': 'PRIMARY', 'title': 'Timed Up and Go (TUG) - OFF Usual Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar Pill\n\nPlacebo: Sugar Pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '24'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '22'}]}]}, {'title': 'Change at 4 weeks', 'categories': [{'measurements': [{'value': '-3.5', 'groupId': 'OG000', 'lowerLimit': '-4.3', 'upperLimit': '-2.7'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '17.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, change at 4 weeks', 'description': 'This is a walking assessment. The subject will begin in the seated position, stand up, walk 7 meters, turn around, and sit back down. The entire process from leaving the chair to returning to the chair will be timed. Also, the Timed Up and Go (TUG) will be done both in the ON and OFF states.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who could complete the task.'}, {'type': 'SECONDARY', 'title': 'Modified Timed Up and Go (mTUG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar Pill\n\nPlacebo: Sugar Pill'}], 'classes': [{'title': 'Baseline - ON', 'categories': [{'measurements': [{'value': '14', 'spread': '0', 'groupId': 'OG000'}, {'value': '16', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'change in 4 weeks - ON', 'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG000'}, {'value': '-1', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - OFF', 'categories': [{'measurements': [{'value': '16', 'spread': '0', 'groupId': 'OG000'}, {'value': '20', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'change in 4 weeks - OFF', 'categories': [{'measurements': [{'value': '2', 'spread': '0', 'groupId': 'OG000'}, {'value': '1', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, change in 4 weeks', 'description': 'The subject sits in the chair approximately 3 1/2 meters away from doorway with the door closed. Subject then stands up and walks one meter to a 40cm X 40cm box taped on the floor. Within the box the patient turns clockwise (360 degrees), then turns counterclockwise (360 degrees). Walk to open the door and walk through the doorway, turn around and return to the chair. Modified Timed Up and Go (mTUG) completed in three components including walking the course without additional tasks, carrying a tray with a cup of water, and counting backwards from 100, in both ON and OFF state.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed task'}, {'type': 'SECONDARY', 'title': "Analysis of Motor Functioning Using the Parkinson's Home Diaries", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar Pill\n\nPlacebo: Sugar Pill'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90', 'spread': '0', 'groupId': 'OG000'}, {'value': '150', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change at 4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '450', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, change in 4 weeks', 'description': 'Subject will record motor activity as OFF, ON (mobility improved) or asleep on the diary every half hour for two days. Subjects further define ON time according to dyskinesia categories "none", "non-troublesome" or "troublesome." The home diaries are used as an evaluation measure of the intervention by assessing the change in off time and change in on time with troublesome dyskinesia. The difference in time experiencing dyskinesia while ON meds relative to the time OFF meds at baseline and at 4 weeks is compared.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'patients who report being ON and OFF medication and experience dyskinesia under either condition at baseline and after 4 weeks of either Amantadine or Placebo.\n\nNOTE: only one patient reported both dyskinesia at baseline and 4 weeks and only under the placebo condition. Others did not report any OFF time, so the difference could not be calculated.'}, {'type': 'SECONDARY', 'title': 'Freezing of Gait Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar Pill\n\nPlacebo: Sugar Pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '17'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '17'}]}]}, {'title': 'Change at 4 weeks', 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, change in 4 weeks', 'description': 'A questionnaire that is used to assess the likelihood of the subject freezing in a number of different scenarios.\n\n0=No freezing of gait to 24=severe freezing of gait', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed questionnaire'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression (CGI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar Pill\n\nPlacebo: Sugar Pill'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'Global Improvement is the second scale in the clinical global impression (CGI). Total overall improvement is judged by whether or not, in the judgment of the assessor, the improvement is entirely due to the drug treatment. It is also a 1-7 point weighted scale, going from "very much improved" (1) to "very much worse" (7). A zero score is assigned if the score is not assessed.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'number completing study up to assessment'}, {'type': 'SECONDARY', 'title': "Parkinson's Disease Questionnaire-39 (PDQ-39)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar Pill\n\nPlacebo: Sugar Pill'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '43'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4', 'description': "The Parkinson's Disease Questionnaire-39 (PDQ39) is a copyrighted instrument to assess symptoms of Parkinson's disease (PD) with 39 questions relating to mobility, activities of daily living, emotional well-being, social support, cognition, communication and bodily discomfort. The test asks subjects to rate each question regarding their Parkinson's disease symptoms over the past month. (range 0 to 100, lower scores reflect better quality of life)", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing questionnaire'}, {'type': 'SECONDARY', 'title': 'Gait Analysis Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar Pill\n\nPlacebo: Sugar Pill'}], 'timeFrame': 'Baseline, week 4, week 7, week 11', 'description': "Use of an accelerometer such as Motorola Droid and wireless acceleration sensors to record gait parameters step time, walking speed, and cadence during the timed up and go (TUG) and modified timed up and go (mTUG) components. The sensors will be attached to the subject's legs and trunk using Velcro straps. The accelerometer will be held or clipped onto the subject in order to measure his or her acceleration. This is done within clinic and during the visit time.", 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected from the portable devices that were used.'}, {'type': 'SECONDARY', 'title': 'Fatigue Severity Scale (FSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar Pill\n\nPlacebo: Sugar Pill'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '32'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '40'}]}]}, {'title': 'change in 4 weeks', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '-5', 'groupId': 'OG001', 'lowerLimit': '-10', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, change in 4 weeks', 'description': 'A questionnaire used to discriminate between Parkinson Disease (PD) patients with fatigue and those without fatigue. Range 9 to 63, higher scores indicate greater fatigue severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed questionnaire'}, {'type': 'SECONDARY', 'title': 'Number Who Completed Medication as Randomized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar Pill\n\nPlacebo: Sugar Pill'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 4', 'description': 'Tolerability analysis as determined by the number of subjects completing each arm of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed study to time of assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Drug Safety Reports', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sugar Pill\n\nPlacebo: Sugar Pill'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4', 'description': 'Analyzing the safety of the medication, Amantadine. Data regarding the medication will be collected from the patient on each visit including any adverse events since the last visit, frequency and severity of falls. This is done in order to determine the safety of Amantadine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amantadine, Then Placebo', 'description': 'Participants first received Amantadine 100 mg tablet orally once a day for one week, then two tablets orally twice a day for one week. After a washout period of 3 weeks, they then placebo tablet (matching Amantadine 100mg tablet) orally for 4 weeks.'}, {'id': 'FG001', 'title': 'Placebo, Then Amantadine', 'description': 'Participants first received Placebo tablet (matching Amantadine 100 mg tablet) orally once a day for one week, then Amantadine placebo two tablets orally twice a day for one week. After a washout period of 4 weeks, then they received Amantadine 100mg tablet orally for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'There was a total of 3 participants enrolled into the study. All 3 participants were randomized to receive either Amantadine or Placebo and crossed over after a washout period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Amantadine Crossover to Placebo', 'description': 'For first 4 weeks of study Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).\n\nCrossover to Placebo (sugar pill) at week 7'}, {'id': 'BG001', 'title': 'Placebo Crossover to Amantadine', 'description': 'For first 4 weeks of study, Placebo (sugar pill)\n\nCrossover to Amantadine at week 7 Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day\n\nAmantadine: Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).'}, {'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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Due to lack of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-23', 'studyFirstSubmitDate': '2011-08-15', 'resultsFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2012-07-27', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-23', 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go (TUG) - ON Usual Medication', 'timeFrame': 'Baseline, change at 4 weeks', 'description': 'This is a walking assessment. The subject will begin in the seated position, stand up, walk 7 meters, turn around, and sit back down. The entire process from leaving the chair to returning to the chair will be timed. Also, the Timed Up and Go (TUG) will be done both in the ON and OFF states.'}, {'measure': 'Timed Up and Go (TUG) - OFF Usual Medication', 'timeFrame': 'Baseline, change at 4 weeks', 'description': 'This is a walking assessment. The subject will begin in the seated position, stand up, walk 7 meters, turn around, and sit back down. The entire process from leaving the chair to returning to the chair will be timed. Also, the Timed Up and Go (TUG) will be done both in the ON and OFF states.'}], 'secondaryOutcomes': [{'measure': 'Modified Timed Up and Go (mTUG)', 'timeFrame': 'Baseline, change in 4 weeks', 'description': 'The subject sits in the chair approximately 3 1/2 meters away from doorway with the door closed. Subject then stands up and walks one meter to a 40cm X 40cm box taped on the floor. Within the box the patient turns clockwise (360 degrees), then turns counterclockwise (360 degrees). Walk to open the door and walk through the doorway, turn around and return to the chair. Modified Timed Up and Go (mTUG) completed in three components including walking the course without additional tasks, carrying a tray with a cup of water, and counting backwards from 100, in both ON and OFF state.'}, {'measure': "Analysis of Motor Functioning Using the Parkinson's Home Diaries", 'timeFrame': 'Baseline, change in 4 weeks', 'description': 'Subject will record motor activity as OFF, ON (mobility improved) or asleep on the diary every half hour for two days. Subjects further define ON time according to dyskinesia categories "none", "non-troublesome" or "troublesome." The home diaries are used as an evaluation measure of the intervention by assessing the change in off time and change in on time with troublesome dyskinesia. The difference in time experiencing dyskinesia while ON meds relative to the time OFF meds at baseline and at 4 weeks is compared.'}, {'measure': 'Freezing of Gait Questionnaire', 'timeFrame': 'Baseline, change in 4 weeks', 'description': 'A questionnaire that is used to assess the likelihood of the subject freezing in a number of different scenarios.\n\n0=No freezing of gait to 24=severe freezing of gait'}, {'measure': 'Clinical Global Impression (CGI)', 'timeFrame': '4 weeks', 'description': 'Global Improvement is the second scale in the clinical global impression (CGI). Total overall improvement is judged by whether or not, in the judgment of the assessor, the improvement is entirely due to the drug treatment. It is also a 1-7 point weighted scale, going from "very much improved" (1) to "very much worse" (7). A zero score is assigned if the score is not assessed.'}, {'measure': "Parkinson's Disease Questionnaire-39 (PDQ-39)", 'timeFrame': 'Baseline, week 4', 'description': "The Parkinson's Disease Questionnaire-39 (PDQ39) is a copyrighted instrument to assess symptoms of Parkinson's disease (PD) with 39 questions relating to mobility, activities of daily living, emotional well-being, social support, cognition, communication and bodily discomfort. The test asks subjects to rate each question regarding their Parkinson's disease symptoms over the past month. (range 0 to 100, lower scores reflect better quality of life)"}, {'measure': 'Gait Analysis Testing', 'timeFrame': 'Baseline, week 4, week 7, week 11', 'description': "Use of an accelerometer such as Motorola Droid and wireless acceleration sensors to record gait parameters step time, walking speed, and cadence during the timed up and go (TUG) and modified timed up and go (mTUG) components. The sensors will be attached to the subject's legs and trunk using Velcro straps. The accelerometer will be held or clipped onto the subject in order to measure his or her acceleration. This is done within clinic and during the visit time."}, {'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': 'Baseline, change in 4 weeks', 'description': 'A questionnaire used to discriminate between Parkinson Disease (PD) patients with fatigue and those without fatigue. Range 9 to 63, higher scores indicate greater fatigue severity.'}, {'measure': 'Number Who Completed Medication as Randomized', 'timeFrame': 'week 4', 'description': 'Tolerability analysis as determined by the number of subjects completing each arm of the study.'}, {'measure': 'Number of Participants With Drug Safety Reports', 'timeFrame': 'Week 4', 'description': 'Analyzing the safety of the medication, Amantadine. Data regarding the medication will be collected from the patient on each visit including any adverse events since the last visit, frequency and severity of falls. This is done in order to determine the safety of Amantadine.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Freezing of gait', 'gait dysfunction'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to explore the efficacy of the drug Amantadine for the treatment of freezing of gait in patients with Parkinson's Disease. The investigators hypothesize that amantadine is useful for management of freezing of gait in subjects with Parkinson's Disease.", 'detailedDescription': 'Subjects who meet the eligibility requirements for the study will be randomized to Amantadine versus a matching placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects with idiopathic PD as determined by UK brain bank diagnostic criteria\n2. H\\&Y stage 2.5-3\n3. Presence of freezing of gait (FOG) as determined by UPDRS Part I score \\> 2\n4. Ability to walk for 2 minutes in the ON and OFF state\n5. Stable regimen of PD medications for 30 days prior to screening\n6. Ability to comply with the study procedures\n7. If female, be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in Section 6.4.10 for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.\n8. Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. Presence of other co morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)\n2. Presence of freezing of gait (FOG) ONLY in medications ON state\n3. Presence of freezing of gait (FOG) ONLY in medications OFF state\n4. Presence of significant cognitive dysfunction as determined by Montreal Cognitive Assessment (MoCA) \\<20\n5. Presence of clinically significant depression as determined by geriatric depression scale (GDS)- 15\\>5\n6. Presence of clinically significant hallucinations\n7. Inability to sign informed consent\n8. Participation in the physical therapy aimed at management of PD for the duration of the study (PT for orthopedic issues will be allowed)\n9. Contraindications for use of Amantadine ( prior history of allergic reaction, history of known renal insufficiency with Cr \\> 2)\n10. If female, be pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT01652534', 'briefTitle': "Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': "Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'M012010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amantadine', 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day', 'interventionNames': ['Drug: Amantadine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Sugar Pill', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Amantadine', 'type': 'DRUG', 'otherNames': ['Symmetrel'], 'description': 'Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).', 'armGroupLabels': ['Amantadine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar Pill'], 'description': 'Sugar Pill', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Tanya Simuni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Professor of Neurology Director, Parkinson's Disease and Movement Disorders Center", 'investigatorFullName': 'Tanya Simuni', 'investigatorAffiliation': 'Northwestern University'}}}}