Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease (TOP-DYSK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01789047
Recruitment Status : Terminated (Sponsor withdrew support)
First Posted : February 11, 2013
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Christopher G. Goetz, MD, Rush University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Idiopathic Parkinson's Disease
Drug Induced Dyskinesia
Interventions Drug: Topiramate
Drug: Placebo
Drug: Amantadine
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topiramate Placebo (Sugar Pill)
Hide Arm/Group Description

Topiramate as adjunct to amantadine.

Topiramate: Topiramate as adjunct to amantadine

Placebo

Placebo: Placebo control

Period Title: Overall Study
Started 21 21
Completed 17 17
Not Completed 4 4
Reason Not Completed
Adverse Event             3             2
Withdrawal by Subject             1             2
Arm/Group Title Topiramate Placebo (Sugar Pill) Total
Hide Arm/Group Description

Topiramate as adjunct to amantadine.

Topiramate: Topiramate as adjunct to amantadine

Placebo

Placebo: Placebo control

Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
61.5  (6.9) 63.1  (8.9) 62.7  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
6
  28.6%
9
  42.9%
15
  35.7%
Male
15
  71.4%
12
  57.1%
27
  64.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 21 participants 21 participants 42 participants
21
 100.0%
21
 100.0%
42
 100.0%
1.Primary Outcome
Title The Unified Dyskinesia Rating Scale (UDysRS)
Hide Description The Unified Dyskinesia Rating Scale (UDysRS) will be the primary outcome measure for this study. This choice is based on the outcome of the Validation of Dyskinesia Rating Scales study. In this study, the UDysRS was identified as the most sensitive scale to detect change in dyskinesia in an 8-week, double-blind, placebo-controlled trial of amatadine. The UDysRS utilizes rater information, patient self-report and objective measures of dyskinesia to provide assessments of impairment and disability due to dyskinesia. Score ranges are 0-108 with higher scores representing more severe impairment.
Time Frame Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward imputation
Arm/Group Title Topiramate Placebo (Sugar Pill)
Hide Arm/Group Description:

Topiramate as adjunct to amantadine.

Topiramate: Topiramate as adjunct to amantadine

Placebo

Placebo: Placebo control

Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.00  (11.34) 1.67  (10.27)
2.Other Pre-specified Outcome
Title Clinical Global Impression - Change Score
Hide Description The Clinical Global Impression - Change score is an ordinal measure of change with a range of 0 (not assessed) to 7 (very much worse). A score of 4 is associated with "no change".
Time Frame Assessed at Week 10 and 14 by blinded treating physician and subject
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Hide Description This is a 4-part scale that rates both non-motor and motor (including dyskinesia) aspects of Parkinson's disease. Parts of the scales will be completed by the blinded treating physician while assessing the subject and other parts will be self-completed by the subject
Time Frame Assessed at baseline, week 6, week 10 and week 14
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Hoehn & Yahr Staging
Hide Description Hoehn & Yahr staging of Parkinson's disease is completed by the blinded treating physician assessing the subject
Time Frame Assessment completed at baseline, week 6, week 10 and week 14
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topiramate Placebo (Sugar Pill)
Hide Arm/Group Description

Topiramate as adjunct to amantadine.

Topiramate: Topiramate as adjunct to amantadine

Placebo

Placebo: Placebo control

All-Cause Mortality
Topiramate Placebo (Sugar Pill)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Topiramate Placebo (Sugar Pill)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/21 (9.52%)      0/21 (0.00%)    
Injury, poisoning and procedural complications     
Fall leading to hospitalization  [1]  1/21 (4.76%)  1 0/21 (0.00%)  0
Nervous system disorders     
Transit Ischemic Attack-like symptoms  [2]  1/21 (4.76%)  1 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Recovered with treatment
[2]
Recovered without treatment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Topiramate Placebo (Sugar Pill)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/21 (76.19%)      12/21 (57.14%)    
Eye disorders     
Blurred vision   3/21 (14.29%)  3 1/21 (4.76%)  1
Gastrointestinal disorders     
Decreased appetite   2/21 (9.52%)  2 0/21 (0.00%)  0
Worsening constipation   0/21 (0.00%)  0 1/21 (4.76%)  1
General disorders     
Biting lower lip   1/21 (4.76%)  1 0/21 (0.00%)  0
Dry mouth   1/21 (4.76%)  1 2/21 (9.52%)  2
Falls   2/21 (9.52%)  2 1/21 (4.76%)  1
Fatigue   1/21 (4.76%)  1 1/21 (4.76%)  1
Headache   1/21 (4.76%)  1 0/21 (0.00%)  0
Tingling fingers and toes   1/21 (4.76%)  1 0/21 (0.00%)  0
Infections and infestations     
Common cold   1/21 (4.76%)  1 0/21 (0.00%)  0
Ottis media   1/21 (4.76%)  1 0/21 (0.00%)  0
Sinus infection   1/21 (4.76%)  1 2/21 (9.52%)  2
Metabolism and nutrition disorders     
Weight gain   0/21 (0.00%)  0 1/21 (4.76%)  1
Weight loss   3/21 (14.29%)  3 0/21 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pre cancerous lesion   1/21 (4.76%)  1 0/21 (0.00%)  0
Nervous system disorders     
Balance instability   1/21 (4.76%)  1 1/21 (4.76%)  1
cognitive decline   0/21 (0.00%)  0 1/21 (4.76%)  1
Confusion   0/21 (0.00%)  0 1/21 (4.76%)  1
Dizziness   2/21 (9.52%)  2 1/21 (4.76%)  1
Increased OFF time   2/21 (9.52%)  2 3/21 (14.29%)  3
Increased dreaming   0/21 (0.00%)  0 1/21 (4.76%)  1
Increased freezing of gait   0/21 (0.00%)  0 1/21 (4.76%)  1
Speech abnormalities   1/21 (4.76%)  1 1/21 (4.76%)  1
Psychiatric disorders     
Hallucinations   2/21 (9.52%)  2 2/21 (9.52%)  2
Respiratory, thoracic and mediastinal disorders     
Cough   2/21 (9.52%)  2 0/21 (0.00%)  0
Intermittent SOB   1/21 (4.76%)  1 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research
Organization: Rush University Medical Center
Phone: 312 942 8002
EMail: Teresa_Chmura@rush.edu
Layout table for additonal information
Responsible Party: Christopher G. Goetz, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01789047     History of Changes
Other Study ID Numbers: TOP-DYSK
First Submitted: February 7, 2013
First Posted: February 11, 2013
Results First Submitted: October 12, 2017
Results First Posted: April 16, 2019
Last Update Posted: April 16, 2019