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Sponsored by: |
University Hospital, Toulouse |
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Information provided by: | University Hospital, Toulouse |
ClinicalTrials.gov Identifier: | 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 antidyskenetic) in patients suffering from Parkinsons 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 disapearance or developpment of undesirable side effects and quality of life.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: mantadix |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Evaluation of the Long-Term Effects of Amantadine in Parkinsian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-Blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK. |
Estimated Enrollment: | 80 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
mantadix
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Drug: mantadix
dose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
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2: Placebo Comparator
placebo
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Drug: mantadix
dose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
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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:
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Atypical parkinsonian syndrome (progressive supranuclear palsy, multi-system atrophy, etc)
Contact: Olivier Rascol, MD | 05 61 779103 | rascol@cict.fr |
France | |
CHU Timone | Recruiting |
Marseille, France, 13385 | |
Contact: Jean-Philippe Azulay, MD 04 91 38 65 79 ext 33 jean-philippe-azulay@ap-hm.fr | |
Hôpital Haut-Lévêque | Recruiting |
Nantes, France, 44095 | |
Contact: Philippe Damier, MD 02 40 16 52 05 philippe.damier@chu-nantes.fr | |
Hôpital d'Aix en Provence | Recruiting |
Aix en Provence, France, 13616 | |
Contact: François Viallet, MD 04 42 33 50 73 viallet@ch-aix.fr | |
CHU Pitié-Salpêtrière | Recruiting |
PARIS, France, 75013 | |
Contact: Dr Lucette Lacomblez, MD 01 40 77 97 00 | |
Contact: Dr Jean-Christophe Corvol, MD 01 40 77 97 00 | |
CHU de Clermont-Ferrand | Recruiting |
Clermont-Ferrand, France, 63003 | |
Contact: Pr Franck Durif, MD 04 73 75 07 50 fdurif@chu_clermontferrand.fr |
Principal Investigator: | Olivier Rascol, MD | CHU Toulouse |
Responsible Party: | UH TOULOUSE ( Marie-Elise LLAU ) |
Study ID Numbers: | 06 008 01 |
Study First Received: | February 20, 2008 |
Last Updated: | February 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00632762 History of Changes |
Health Authority: | France: Ministry of Health |
Amantadine benefit Dyskinesia Parkinson's disease |
Neurotransmitter Agents Levodopa Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias Antiviral Agents |
Dopamine Analgesics, Non-Narcotic Parkinson Disease Movement Disorders Dopamine Agents Peripheral Nervous System Agents Analgesics Parkinsonian Disorders Amantadine |
Anti-Infective Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Antiparkinson Agents Brain Diseases Neurodegenerative Diseases Antiviral Agents |
Pharmacologic Actions Sensory System Agents Analgesics, Non-Narcotic Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Analgesics Parkinsonian Disorders Amantadine Central Nervous System Agents |