mantadix
Drugdose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
NCT Number: NCT00632762
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.
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Notify Me30 year–80 year
All sexes
Interventional
Phase 4
Hôpital d'Aix en Provence, Aix-en-Provence, France
The trial will involve the participation of the patients for a period of 3 months each. The two groups of patients to be studied are:
The trial visits are scheduled as such:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
dose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
University Hospital, Toulouse
Other
Evaluation of the Long-term Effects of Amantadine in Parkinsonian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK.
Acronym: AMANDYSK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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