Trial Outcomes & Findings for Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease (NCT NCT00794313)
NCT ID: NCT00794313
Last Updated: 2018-02-01
Results Overview
Area under the curve for the root mean squared velocity in the anterior-posterior direction as measured by a forceplate.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
Every 1/2 hour for 8 hour levodopa cycle
Results posted on
2018-02-01
Participant Flow
4 individuals were screened for this study. 3 participants were enrolled in the study. 1 participant screen failed due to inability to reduce/stop Amantadine.
Participant milestones
| Measure |
Amantadine, Then Amantadine + Topiramate, Then Placebo
Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2) then 7 Days washout then Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2) then 7 Days washout then Placebo: Sugar pill 2 capsule three times a day, 2 weeks
|
Amantadine + Topiramate, Then Placebo, Then Amantadine
Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2) then 7 Days washout then Placebo: Sugar pill 2 capsule three times a day, 2 weeks then 7 Days washout then Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2)
|
Placebo, Then Amantadine, Then Amantadine + Topiramate
Placebo: Sugar pill 2 capsule three times a day, 2 weeks then 7 Days washout then Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2) then 7 Days washout then Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2)
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
All Study Participants
n=3 Participants
Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks or Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week or Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
|
MoCA total
|
27.7 units on a scale
STANDARD_DEVIATION 1.3 • n=99 Participants
|
|
UPDRS (Part III) Total Score
|
16.0 units on a scale
STANDARD_DEVIATION 1.0 • n=99 Participants
|
|
mAIMS
|
7 units on a scale
STANDARD_DEVIATION 7.2 • n=99 Participants
|
PRIMARY outcome
Timeframe: Every 1/2 hour for 8 hour levodopa cyclePopulation: triple cross-over study design.
Area under the curve for the root mean squared velocity in the anterior-posterior direction as measured by a forceplate.
Outcome measures
| Measure |
Amantadine
n=3 Participants
Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
|
Amantadine Plus Topiramate
n=3 Participants
Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week
|
Sugar Pill
n=3 Participants
Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
|
|---|---|---|---|
|
Forceplate AUC
|
10.4 (meters/second)*hours
Standard Deviation 5.6
|
9.4 (meters/second)*hours
Standard Deviation 3.5
|
19.1 (meters/second)*hours
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: Measured every 1/2 hour for a levodopa dose cycle (starting 1 hour prior to infusion and ending 4 hours post 2-hour infusion)Area under the curve computed for whole body (total) mAIMS (Modified Abnormal Involuntary Movement Scale) scores at each time measurement. This is a commonly utilized scale that is completed by an observer who judges the severity of levodopa induced dyskinesia (LID) in 7 body parts (face, neck, trunk, both legs, and both arms). All body parts are rated separately on this 0 (none) to 4 (severe - markedly impairs activities) scale. Thus, the total score can range from 0 - 28 with 28 indicating the most severe LID. mAIMS ratings occur as the subject performs the cognitive task while standing on the force plate. mAIMS ratings are made every half hour during the levodopa (LD) dose cycle.
Outcome measures
| Measure |
Amantadine
n=3 Participants
Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
|
Amantadine Plus Topiramate
n=3 Participants
Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week
|
Sugar Pill
n=3 Participants
Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
|
|---|---|---|---|
|
Modified Abnormal Involuntary Movement Scale Area Under the Curve
|
4.0 Units on a Scale * Hours
Standard Deviation 2.9
|
5.3 Units on a Scale * Hours
Standard Deviation 4.4
|
8.5 Units on a Scale * Hours
Standard Deviation 8.6
|
Adverse Events
Amantadine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amantadine Plus Topiramate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amantadine
n=3 participants at risk
Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
|
Amantadine Plus Topiramate
n=3 participants at risk
Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week
|
Sugar Pill
n=3 participants at risk
Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
|
|---|---|---|---|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/3 • 6 Weeks
|
33.3%
1/3 • Number of events 1 • 6 Weeks
|
0.00%
0/3 • 6 Weeks
|
|
Psychiatric disorders
HALLUCINATIONS
|
0.00%
0/3 • 6 Weeks
|
33.3%
1/3 • Number of events 1 • 6 Weeks
|
33.3%
1/3 • Number of events 1 • 6 Weeks
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/3 • 6 Weeks
|
0.00%
0/3 • 6 Weeks
|
33.3%
1/3 • Number of events 1 • 6 Weeks
|
|
General disorders
FATIGUE
|
0.00%
0/3 • 6 Weeks
|
0.00%
0/3 • 6 Weeks
|
33.3%
1/3 • Number of events 1 • 6 Weeks
|
|
General disorders
FLU LIKE SYMPTOMS
|
0.00%
0/3 • 6 Weeks
|
0.00%
0/3 • 6 Weeks
|
33.3%
1/3 • Number of events 1 • 6 Weeks
|
|
Nervous system disorders
PARESTHESIA
|
0.00%
0/3 • 6 Weeks
|
33.3%
1/3 • Number of events 1 • 6 Weeks
|
0.00%
0/3 • 6 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place