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

NCT00794313 | Terminated Results

• 1 other identifier: e4717
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinsons disease; dyskinesia; amantadine; efficacy

Outcome Measures

Primary Outcomes (1)

• Forceplate AUC

  Area under the curve for the root mean squared velocity in the anterior-posterior direction as measured by a forceplate.

  Every 1/2 hour for 8 hour levodopa cycle

Secondary Outcomes (1)

• Modified Abnormal Involuntary Movement Scale Area Under the Curve

  Measured every 1/2 hour for a levodopa dose cycle (starting 1 hour prior to infusion and ending 4 hours post 2-hour infusion)

Study Arms (3)

Amantadine

EXPERIMENTAL

Drug: Amantadine 300 mg

Amantadine plus Topiramate

EXPERIMENTAL

Drug: Amantadine 300 mg; Drug: Topiramate

Sugar Pill

PLACEBO COMPARATOR

Drug: Sugar Pill

Interventions

Amantadine 300 mg DRUG

Amantadine, 300 mg, capsule, three times a day, two weeks

Amantadine; Amantadine plus Topiramate

Topiramate DRUG

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

Also known as: Topamax

Amantadine plus Topiramate

Sugar Pill DRUG

sugar pill, capsule, three times a day, 2 weeks

Sugar Pill

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (5)

• Snow BJ, Macdonald L, Mcauley D, Wallis W. The effect of amantadine on levodopa-induced dyskinesias in Parkinson's disease: a double-blind, placebo-controlled study. Clin Neuropharmacol. 2000 Mar-Apr;23(2):82-5. doi: 10.1097/00002826-200003000-00004.

  PMID: 10803797 BACKGROUND

• Verhagen Metman L, Del Dotto P, van den Munckhof P, Fang J, Mouradian MM, Chase TN. Amantadine as treatment for dyskinesias and motor fluctuations in Parkinson's disease. Neurology. 1998 May;50(5):1323-6. doi: 10.1212/wnl.50.5.1323.

  PMID: 9595981 BACKGROUND

• Del Dotto P, Pavese N, Gambaccini G, Bernardini S, Metman LV, Chase TN, Bonuccelli U. Intravenous amantadine improves levadopa-induced dyskinesias: an acute double-blind placebo-controlled study. Mov Disord. 2001 May;16(3):515-20. doi: 10.1002/mds.1112.

  PMID: 11391748 BACKGROUND

• Hagell P, Widner H. Clinical rating of dyskinesias in Parkinson's disease: use and reliability of a new rating scale. Mov Disord. 1999 May;14(3):448-55. doi: 10.1002/1531-8257(199905)14:33.0.co;2-0.

  PMID: 10348468 BACKGROUND

• da Silva-Junior FP, Braga-Neto P, Sueli Monte F, de Bruin VM. Amantadine reduces the duration of levodopa-induced dyskinesia: a randomized, double-blind, placebo-controlled study. Parkinsonism Relat Disord. 2005 Nov;11(7):449-52. doi: 10.1016/j.parkreldis.2005.05.008. Epub 2005 Sep 9.

  PMID: 16154788 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

Amantadine; Topiramate; Sugars

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fructose; Hexoses; Monosaccharides; Carbohydrates; Ketoses

Results Point of Contact

• Title: Kathyrn Chung MD
• Organization: Oregon Health & Science Universtiy

chungka@ohsu.edu

503 721 - 1091

Study Officials

• Kathryn Chung, MD

  Oregon Health & Science University, Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

• John G Nutt, MD

  Oregon Health & Science Unversity

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 20, 2008
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 1, 2018
• Results First Posted: May 11, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)