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

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: 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

Tracking Information
First Submitted Date  ICMJE November 19, 2008
First Posted Date  ICMJE November 20, 2008
Results First Submitted Date  ICMJE September 29, 2016
Results First Posted Date  ICMJE May 11, 2017
Last Update Posted Date February 1, 2018
Study Start Date  ICMJE September 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
Forceplate AUC [ Time Frame: Every 1/2 hour for 8 hour levodopa cycle ]
Area under the curve for the root mean squared velocity in the anterior-posterior direction as measured by a forceplate.
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
Forceplate Measurement of Dyskinesia [ Time Frame: 2 weeks, 5 weeks, 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
Modified Abnormal Involuntary Movement Scale Area Under the Curve [ 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) ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
Inertial Sensor Signal [ Time Frame: 2 weeks, 5 weeks, 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease
Official Title  ICMJE Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease
Brief Summary Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias. A drug called amantadine can reduce these movements. To date, there are no objective measures of these movements. The purpose of this study is to measure the reduction of the movements by amantadine and/or topiramate using an objective measure.
Detailed Description

Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Currently, one of the very few treatments for these unwanted and involuntary movements is Amantadine. New options to treat dyskinesia would be clinically very valuable. In a previous study, we developed an objective measuring device to quantify dyskinesia.

All PD participants will receive all three of the drug treatment intervention (placebo, Amantadine 300 mg, Amantadine 300 mg plus Topiramate 150 mg). After 2 weeks of one drug treatment, the participants will complete an overnight visit at the OCTRI Inpatient unit. During the next day, participants will complete a mental task while standing on a force plate for one minute every half hour until the end of the study. A levodopa IV infusion will occur from 0900 to 1100. The subjects will be split into 'high' and 'low' dose groups. Those who take <50 mg/hour of oral levodopa or levodopa equivalents will be considered 'low' dose subjects and will receive 1 mg/kg/hr of IV Levodopa during the study visits (1, 2, and 3). Those who administer > 50 mg/hr of oral levodopa to themselves normally will be considered 'high' dose subjects and will received 1.5 mg/kg/hr levodopa. Both groups will receive the infusion for two hours from 0900 - 1100. The study drug will be taken orally at 0800.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: Amantadine 300 mg
    Amantadine, 300 mg, capsule, three times a day, two weeks
  • Drug: 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
    Other Name: Topamax
  • Drug: Sugar Pill
    sugar pill, capsule, three times a day, 2 weeks
Study Arms  ICMJE
  • Experimental: Amantadine
    Intervention: Drug: Amantadine 300 mg
  • Experimental: Amantadine plus Topiramate
    Interventions:
    • Drug: Amantadine 300 mg
    • Drug: Topiramate
  • Placebo Comparator: Sugar Pill
    Intervention: Drug: Sugar Pill
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 3, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2008)
18
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Parkinson's Disease
  • At least 21 years of age
  • Must be taking Oral levodopa
  • Must have dyskinesias by history or previous clinical observation

Exclusion Criteria:

  • Significant cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA) score of < 25
  • Subjects with unstable medical or psychiatric conditions (including hallucinations)
  • Use of dopamine receptor blocking medications (e.g., neuroleptics, certain antiemetics, tetrabenazine)
  • History of unstable medical conditions (ie active cardiovascular disease, recent unwellness or surgery etc.)
  • Use of anticoagulants
  • Current substance abuse
  • Previous adverse event on amantadine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00794313
Other Study ID Numbers  ICMJE e4717
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kathryn Anne Chung, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathryn Chung, MD Oregon Health & Science University, Portland VA Medical Center
Principal Investigator: John G Nutt, MD Oregon Health & Science Unversity
PRS Account Oregon Health and Science University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP