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

This study has been terminated.
(Funding Ended)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00794313
First Posted: November 20, 2008
Last Update Posted: May 11, 2017
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.
Information provided by (Responsible Party):
Kathryn Anne Chung, Oregon Health and Science University
  Purpose
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.

Condition Intervention
Parkinson's Disease Drug: Amantadine 300 mg Drug: Topiramate Drug: Sugar Pill

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Kathryn Anne Chung, Oregon Health and Science University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 3
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amantadine Drug: Amantadine 300 mg
Amantadine, 300 mg, capsule, three times a day, two weeks
Experimental: Amantadine plus Topiramate 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
Placebo Comparator: Sugar Pill Drug: Sugar Pill
sugar pill, capsule, three times a day, 2 weeks

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794313


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Kathryn Chung, MD Oregon Health & Science University, Portland VA Medical Center
Principal Investigator: John G Nutt, MD Oregon Health & Science Unversity
  More Information

Publications:
Responsible Party: Kathryn Anne Chung, Associate Professor, 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: May 11, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kathryn Anne Chung, Oregon Health and Science University:
Parkinsons disease
dyskinesia
amantadine
efficacy

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Topiramate
Amantadine
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents