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Due to lack of recruitment
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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.
Subjects who meet the eligibility requirements for the study will be randomized to Amantadine versus a matching placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amantadine | Active Comparator | Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day |
|
| placebo | Placebo Comparator | Sugar Pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amantadine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go (TUG) - ON Usual Medication | 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. | Baseline, change at 4 weeks |
| Timed Up and Go (TUG) - OFF Usual Medication | 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. | Baseline, change at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Timed Up and Go (mTUG) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanya Simuni, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amantadine, Then Placebo | 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. |
| FG001 | Placebo, Then Amantadine | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amantadine Crossover to Placebo | 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 Amantadine: 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). Crossover to Placebo (sugar pill) at week 7 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Timed Up and Go (TUG) - ON Usual Medication | 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. | 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. | Posted | Median | Full Range | seconds | Baseline, change at 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amantadine | Participants during Amantadine 100 mg tablet orally once a day for one week, then two tablets orally twice a day for one week. |
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Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tanya Simuni | Northwestern University | 312-503-2970 | tsimuni@nm.org |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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|
| Placebo | Drug | Sugar Pill |
|
|
| Baseline, change in 4 weeks |
| Analysis of Motor Functioning Using the Parkinson's Home Diaries | 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. | Baseline, change in 4 weeks |
| Freezing of Gait Questionnaire | A questionnaire that is used to assess the likelihood of the subject freezing in a number of different scenarios. 0=No freezing of gait to 24=severe freezing of gait | Baseline, change in 4 weeks |
| Clinical Global Impression (CGI) | 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. | 4 weeks |
| Parkinson's Disease Questionnaire-39 (PDQ-39) | 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) | Baseline, week 4 |
| Gait Analysis Testing | 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. | Baseline, week 4, week 7, week 11 |
| Fatigue Severity Scale (FSS) | 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. | Baseline, change in 4 weeks |
| Number Who Completed Medication as Randomized | Tolerability analysis as determined by the number of subjects completing each arm of the study. | week 4 |
| Number of Participants With Drug Safety Reports | 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. | Week 4 |
| BG001 | Placebo Crossover to Amantadine | For first 4 weeks of study, Placebo (sugar pill) Crossover to Amantadine at week 7 Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day Amantadine: 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Sugar Pill Placebo: Sugar Pill |
|
|
| Primary | Timed Up and Go (TUG) - OFF Usual Medication | 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. | participants who could complete the task. | Posted | Median | Full Range | seconds | Baseline, change at 4 weeks |
|
|
|
| Secondary | Modified Timed Up and Go (mTUG) | 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. | participants who completed task | Posted | Mean | Standard Deviation | seconds | Baseline, change in 4 weeks |
|
|
|
| Secondary | Analysis of Motor Functioning Using the Parkinson's Home Diaries | 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. | 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. NOTE: 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. | Posted | Median | Standard Deviation | minutes | Baseline, change in 4 weeks |
|
|
|
| Secondary | Freezing of Gait Questionnaire | A questionnaire that is used to assess the likelihood of the subject freezing in a number of different scenarios. 0=No freezing of gait to 24=severe freezing of gait | Participants who completed questionnaire | Posted | Median | Full Range | score on a scale | Baseline, change in 4 weeks |
|
|
|
| Secondary | Clinical Global Impression (CGI) | 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. | number completing study up to assessment | Posted | Median | Full Range | score on a scale | 4 weeks |
|
|
|
| Secondary | Parkinson's Disease Questionnaire-39 (PDQ-39) | 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) | Participants completing questionnaire | Posted | Mean | Full Range | score on a scale | Baseline, week 4 |
|
|
|
| Secondary | Gait Analysis Testing | 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. | No data was collected from the portable devices that were used. | Posted | Baseline, week 4, week 7, week 11 |
|
|
| Secondary | Fatigue Severity Scale (FSS) | 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. | Participants who completed questionnaire | Posted | Mean | Full Range | score on a scale | Baseline, change in 4 weeks |
|
|
|
| Secondary | Number Who Completed Medication as Randomized | Tolerability analysis as determined by the number of subjects completing each arm of the study. | participants who completed study to time of assessment | Posted | Count of Participants | Participants | week 4 |
|
|
|
| Secondary | Number of Participants With Drug Safety Reports | 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. | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Placebo | Participants during Placebo tablet (matching Amantadine 100 mg tablet) | 0 | 2 | 0 | 2 | 0 | 2 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009930 |
| Organic Chemicals |
| D002241 | Carbohydrates |
| Baseline - OFF |
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| change in 4 weeks - OFF |
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| Change at 4 weeks |
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| Week 4 |
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