Status:
COMPLETED
Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK)
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief 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 eval...
Detailed Description
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: * a group who will continue their treatment with Amantadine with ...
Eligibility Criteria
Inclusion
- Female or Male Patients with Idiopathic Parkinson's disease
- Presenting peak dose dyskinesias under levodopa therapy
- Patient receiving Amantadine for dyskinesia at a dose greater or equal to 200 mg/day (minimum dose at which one can observe anti dyskinetic effects) for at least 6 months.
- Patients between 30 and 80 years of age
- Patients having reported a subjective amelioration in their dyskinesias under Amantadine (at the beginning of their treatment with same)
- Patient with a Mini- Mental State Exam score \> 24
- Patient not presenting a cognitive problem that could impair the comprehension of the patient and their participation in the protocol (patient diaries)
- Receiving an anti-parkinsonian treatment at a stable dose for at least 2 months with the expectation that the treatment will remain unchanged throughout the course of the patients participation in the trial.
- Signed informed consent obtained
- Patient eligible for social security (specific requirement under french law)
Exclusion
- Atypical parkinsonian syndrome (progressive supranuclear palsy, multi-system atrophy, etc)
- Patient with parkinsonian syndrome secondary to medication
- Patients presenting with dyskinesias whose severity allow an insufficient margin for observing any aggravation which follows a potential withdrawal of treatment (UPDRS 32+33 \>6)
- Patients receiving treatment with Apokinon© injector pens (unless that treatment enters into a therapeutic schema at fixed hours)
- Patient presenting with dementia or an evolving dopaminergic psychosis
- Patient receiving neuroleptics or anticholinesterases
- Patients having received functional surgery for their Parkinsons' Disease
- Patients pregnant or at risk of same
- Patients who are: wards of the state requirement under french law).
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00632762
Start Date
November 1 2007
End Date
January 1 2011
Last Update
April 8 2011
Active Locations (5)
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1
Hôpital d'Aix en Provence
Aix-en-Provence, France, 13616
2
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
3
CHU Timone
Marseille, France, 13385
4
Hôpital Haut-Lévêque
Nantes, France, 44095