- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01146548
Fluoxetine in Multiple System Atrophy Patients (MSA-Fluox)
Assessment of Fluoxetine's Effect in Patients With Multiple System Atrophy : a Double Blind Placebo-controlled Randomized Trial
This is a French national trial, conducted using a double-blind, placebo-controlled, randomised design involving 15 centers and 88 patients of both sexes.
The primary objective of the trial is to evaluate the effect of a selective inhibitor of serotonin reuptake, the Fluoxétine, at a higher dose (40 mg/day) than usually recommended for depressed patients, after three months in patients suffering from an atypical Parkinson's disease called Multiple System Atrophy, compared to the placebo effect.
Secondary objectives of the trial are the evaluation of the effects of Fluoxétine after six weeks at the dose of 20 mg/day, after six months at the dose of 40mg/day, and assess the effects on mortality, quality of life, autonomic disorders, particularly orthostatic hypotension, mood and others symptoms such as sleep, apathy, pain and fatigue.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Aix en Provence, France
- hospital center of Aix enProvence
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Clermont-Ferrand, France
- Hospital Gabriel Montpied
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Creteil, France
- University Hospital Henri Mondor
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Dijon, France
- Hopital
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Lille, France
- Hospital R Salengro
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Limoges, France
- University Hospital Dupuytren
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Marseille, France
- university hospital Timone
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Montpellier, France
- University Hospital
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Nantes, France
- Hospital
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Paris, France
- Hospital Pitie Salpetriere
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Poitiers, France
- University Hospital La MILETRIE
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Rennes, France
- Hospital Pontchaillou
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Strasbourg, France
- Civil Hospital of Strasbourg
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Toulouse, France, 31000
- University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female or Male Patient with Multiple System Atrophy's disease diagnosed according to international consensus criteria (Gilman's criteria)
- Patient between 30 and 80 years of age
- Patient not presenting a cognitive problem that could impair the comprehension of the patient and his participation in the protocol
- Patient receiving an anti-parkinsonian treatment (if applicable) at a stable dose for at least 2 months before entering the study, and with the expectation that the treatment will remain unchanged throughout the course of the patients participation in the trial
- Patient receiving a symptomatic treatment of autonomic disorders (if applicable) at a stable dose for at least 2 months before entering the study, and with the expectation that the treatment will remain unchanged throughout the course of the patient participation in the trial
- Signed informed consent obtained
- Patient eligible for social security (specific requirement under French law)
Exclusion Criteria:
- Patient presenting major swallowing problems as he will not take capsule
- Patient already receiving a selective inhibitor of serotonin reuptake or other antidepressant, or patient having received one in the 3 months preceding the start of the study
- Patient with major depressive syndrome for which the investigator considers that the indication of an antidepressant seems essential
- Bedridden patient or confined to a wheelchair during the whole day
- Patient with severe hyponatremia
- Patient with another Parkinsonian's syndrome that the Multiple System Atrophy (type of atypical Parkinson's disease, progressive supra nuclear paralysis, cortico-basal degeneration)
- Patient with dementia
- Patient with a Mini-Mental State Exam score < 24
- Patient unable to understand the protocol or another endpoint or to consider the clinical trial's process
- Patient with a chronic disease affecting the development or assessment of the patient during the trial
- Patient receiving concomitant medications which could affect the evaluation of outcome measures (e.g. neuroleptics for the assessment of parkinsonian symptoms, vasodilators for the assessment of orthostatic hypotension, sedative drugs prescribed during the day for the assessment of the daytime sleepiness, of apathy or of fatigue)
- Patient with absolute or relative contraindications of Fluoxetine (hypersensitivity to Fluoxetine, patient with a history of epilepsy, of manic state, of severe hepatic or renal impairment, of skin bleeding, of severe heart, of uncontrolled diabete, patient treated by selective or non selective IMAO)
- Person who are: wards of the state or prisoners (requirement under french law)
- Patient pregnant or at risk of same, nursing mother
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: the fluoxetine group
Multiple System Atrophy's patients with fluoxétine
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20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.
Other Names:
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Placebo Comparator: the placebo group
Multiple System Atrophy's patients with placebo
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20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
primary efficacy endpoint
Time Frame: 3 months
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The primary efficacy endpoint is the comparison of scores in Parts I and II of the UMSARS scale between the visit V0 and V2 (i.e. after 3 months of treatment at the dose of 40mg/day).
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
secondary efficacy endpoints
Time Frame: 6 weeks, 3 months or 6 months
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6 weeks, 3 months or 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Olivier Rascol, MD, Hospital University Toulouse
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Pathological Conditions, Anatomical
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Hypotension
- Atrophy
- Multiple System Atrophy
- Shy-Drager Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- 0720101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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