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Quantification of the Antidyskinetic Effect of Amantadine in Parkinson's Disease
This study is not yet open for participant recruitment.
Verified by Oregon Health and Science University, November 2008
Sponsored by: Oregon Health and Science University
Information provided by: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00794313
  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 using an objective measure.


Condition Intervention
Parkinson's Disease
Drug: Amantadine 200 mg
Drug: Amantadine 300 mg
Drug: Sugar Pill

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Amantadine Amantadine hydrochloride Amantadine sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Quantification of the Antidyskinetic Effect of Amantadine in Parkinson's Disease

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Forceplate Measurement of Dyskinesia [ Time Frame: 2 weeks, 5 weeks, 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inertial Sensor Signal [ Time Frame: 2 weeks, 5 weeks, 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Amantadine 200 mg: Experimental Drug: Amantadine 200 mg
Amantadine, 200 mg, capsule, two times a day, two weeks Placebo, n/a, capsule, one time a day, two weeks
Amantadine 300 mg: Experimental Drug: Amantadine 300 mg
Amantadine, 300 mg, capsule, three times a day, 2 weeks
Sugar Pill: Placebo Comparator 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. 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 200 mg, Amantadine 300 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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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 <255
  • Subjects with unstable medical or psychiatric conditions (including hallucinations).
  • Use of dopamine receptor blocking medications (e.g.neuroleptics, certain antiemertics, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794313

Contacts
Contact: Brenna Lobb, MS 503 220 8262 ext 51871 Brenna.Lobb@va.gov
Contact: PADRECC 503 721 1091

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: Oregon Health & Science University ( Kathryn Chung, MD )
Study ID Numbers: e4717
Study First Received: November 19, 2008
Last Updated: November 19, 2008
ClinicalTrials.gov Identifier: NCT00794313  
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
Parkinsons disease
dyskinesia
amantadine
efficacy

Study placed in the following topic categories:
Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Amantadine
Neurodegenerative Diseases
Brain Diseases
Dyskinesias

Additional relevant MeSH terms:
Anti-Infective Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Antiviral Agents
Pharmacologic Actions
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009