Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A double-blinded randomized placebo-controlled trial of intravenous amantadine on gait freezing refractory to oral anti-parkinsonian medications in patients with Parkinson's disease.

• administration of IV amantadine or normal saline for 5 days, 2 times a day while keeping current oral anti-parkinsonian medications unchanged

• follow-up after administration of IV amantadine for 4 weeks

• allocation ratio of amantadine:normal saline is 2:1

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jee-Young Lee
• Collaborators: Hanyang University; Samsung Medical Center; Seoul National University Boramae Hospital; Seoul National University Bundang Hospital
• Treatments: Amantadine

Criteria

Inclusion Criteria:

• the diagnosis of Parkinson's disease according to the United Kingdom Parkinson's Disease Brain Bank criteria

• presence of freezing of gait and the scores of Freezing of Gait Questionnaire 7 or more

• having been treated with oral dopamine replacement therapy for 6 months or more

• score of Korean version of mini-mental status examination is 20 or more

Exclusion Criteria:

• presence of significant cognitive dysfunction, behavioral or psychiatric disorders

• presence of severe cardiac disease

• presence of renal failure, seizure, peptic ulcer disease, liver disease, pheochromocytoma, chronic exhaustive disease, or malignancy

• participation to other clinical trial within 4 weeks

• pregnancy or lactating women

• hypersensitivity to study drugs

• history of intoxication to heavy metals