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Sponsored by: |
Oregon Health and Science University |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00794313 |
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 |
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Parkinson's Disease |
Drug: Amantadine 200 mg Drug: Amantadine 300 mg Drug: Sugar Pill |
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 |
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 |
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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
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Amantadine 300 mg: Experimental |
Drug: Amantadine 300 mg
Amantadine, 300 mg, capsule, three times a day, 2 weeks
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Sugar Pill: Placebo Comparator |
Drug: Sugar Pill
sugar pill, capsule, three times a day, 2 weeks
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brenna Lobb, MS | 503 220 8262 ext 51871 | Brenna.Lobb@va.gov |
Contact: PADRECC | 503 721 1091 |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Kathryn Chung, MD | Oregon Health & Science University, Portland VA Medical Center |
Principal Investigator: | John G Nutt, MD | Oregon Health & Science Unversity |
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 |
Parkinsons disease dyskinesia amantadine efficacy |
Dopamine Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases Central Nervous System Diseases |
Parkinsonian Disorders Amantadine Neurodegenerative Diseases Brain Diseases Dyskinesias |
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 |