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Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00794313
Recruitment Status : Terminated (Funding Ended)
First Posted : November 20, 2008
Results First Posted : May 11, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Kathryn Anne Chung, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: Amantadine 300 mg
Drug: Topiramate
Drug: Sugar Pill
Enrollment 3
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Amantadine, Then Amantadine + Topiramate, Then Placebo Amantadine + Topiramate, Then Placebo, Then Amantadine Placebo, Then Amantadine, Then Amantadine + Topiramate
Hide Arm/Group Description 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: 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: 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)
Period Title: Overall Study
Started 1 1 1
Completed 1 1 1
Not Completed 0 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description

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

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
MoCA total   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 3 participants
27.7  (1.3)
[1]
Measure Description: The MoCA is a short cognitive screening test designed to assist health care professionals for the detection of mild cognitive impairment. The MoCA assesses cognitive function across a variety of domains. The MoCA is scored on a 0 to 30 scale, with lower numbers indicating more cognitive impairment. A point is added to the MoCA if the subject's education high school or less (12 years or less education). Scores ranging from 26 - 30 are normal, 18 - 26 mild impairment, 10 - 17 moderate impairment, and less than 10 severe cognitive impairment.
UPDRS (Part III) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 3 participants
16.0  (1.0)
[1]
Measure Description: This is the motor subsection of the UPDRS and is a commonly used tool to rate the symptoms of Parkinson‘s disease. Each item on the scale is rated from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. Total score ranges from 0 to 108 with higher values on this scale represent a more severe stage of the disease.
mAIMS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 3 participants
7  (7.2)
[1]
Measure Description: Modified Abnormal Involuntary Movment Rating Scale (mAIMS) is a commonly utilized scale that is completed by an observer who judges the severity of dyskinesia 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 severe dyskinesia.
1.Primary Outcome
Title Forceplate AUC
Hide Description Area under the curve for the root mean squared velocity in the anterior-posterior direction as measured by a forceplate.
Time Frame Every 1/2 hour for 8 hour levodopa cycle
Hide Outcome Measure Data
Hide Analysis Population Description
triple cross-over study design.
Arm/Group Title Amantadine Amantadine Plus Topiramate Sugar Pill
Hide Arm/Group Description:
Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks

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 : sugar pill, capsule, three times a day, 2 weeks
Overall Number of Participants Analyzed 3 3 3
Mean (Standard Deviation)
Unit of Measure: (meters/second)*hours
10.4  (5.6) 9.4  (3.5) 19.1  (18.8)
2.Secondary Outcome
Title Modified Abnormal Involuntary Movement Scale Area Under the Curve
Hide Description 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.
Time Frame Measured every 1/2 hour for a levodopa dose cycle (starting 1 hour prior to infusion and ending 4 hours post 2-hour infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amantadine Amantadine Plus Topiramate Sugar Pill
Hide Arm/Group Description:
Amantadine 300 mg: Amantadine, 300 mg, capsule, three times a day, two weeks

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: sugar pill, capsule, three times a day, 2 weeks
Overall Number of Participants Analyzed 3 3 3
Mean (Standard Deviation)
Unit of Measure: Units on a Scale * Hours
4.0  (2.9) 5.3  (4.4) 8.5  (8.6)
Time Frame 6 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amantadine Amantadine Plus Topiramate Sugar Pill
Hide Arm/Group Description Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks

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 : sugar pill, capsule, three times a day, 2 weeks
All-Cause Mortality
Amantadine Amantadine Plus Topiramate Sugar Pill
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Amantadine Amantadine Plus Topiramate Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Amantadine Amantadine Plus Topiramate Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      2/3 (66.67%)      3/3 (100.00%)    
Gastrointestinal disorders       
NAUSEA * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1
General disorders       
FATIGUE * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1
FLU LIKE SYMPTOMS * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1
Nervous system disorders       
SOMNOLENCE * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0
PARESTHESIA * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0
Psychiatric disorders       
HALLUCINATIONS * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 4.3
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kathyrn Chung MD
Organization: Oregon Health & Science Universtiy
Phone: 503 721 - 1091
Responsible Party: Kathryn Anne Chung, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00794313     History of Changes
Other Study ID Numbers: e4717
First Submitted: November 19, 2008
First Posted: November 20, 2008
Results First Submitted: September 29, 2016
Results First Posted: May 11, 2017
Last Update Posted: February 1, 2018