drugset / Trial / NCT00632762

Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK)

NCT00632762

Phase 4 Completed 80 enrolled University Hospital, Toulouse
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a French national trial, conducted using a double-blind, placebo-controlled, randomised design involving 7 centers and 80 patients of both sexes. The primary objective of the trial is to evaluate the effects of the interruption of a long term treatment (ex. Greater than 6 months) with Amantadine (prescribed as an antidyskinetic) in patients suffering from Parkinson disease being treated with Levodopa and suffering from mid dose dyskinesias. Secondary objectives of the trial are the evaluation of the other effects of withdrawal of Amantadine on the same group of patients: motor fluctuations, vigilance, apathy, fatigue, certain cognitive aspects, the disappearance or development of undesirable side effects and quality of life.

Timeline

Start
2007-11
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amantadine Unknown 200 mg

Indications