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Fluoxetine in Multiple System Atrophy Patients (MSA-Fluox)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01146548
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Multiple System Atrophy Drug: FLUOXETINE Phase 2

Detailed Description:
Fluoxetine is first introduced in dose of 20 mg/day and after six weeks the dose is increased to 40 mg/day. If patients have side effects at the dose of 40 mg/day, the dose may be reduced at 20 mg/day. Assessment visits will be conducted at 6 weeks, 3 months, and 6 months of treatment. After 6 months, trial's treatment with fluoxetine is discontinued gradually. A new assessment will be conducted one month after the end of treatment. The expected results are the demonstration of improved scores of the scale UMSARS after 3 and 6 months in the fluoxetine group compared to the placebo group.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Assessment of Fluoxetine's Effect in Patients With Multiple System Atrophy : a Double Blind Placebo-controlled Randomized Trial
Study Start Date : May 2008
Primary Completion Date : June 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: the fluoxetine group
Multiple System Atrophy's patients with fluoxétine
20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.
Other Name: PROZAC®
Placebo Comparator: the placebo group
Multiple System Atrophy's patients with placebo
20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.
Other Name: PROZAC®

Outcome Measures

Primary Outcome Measures :
  1. primary efficacy endpoint [ Time Frame: 3 months ]
    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).

Secondary Outcome Measures :
  1. secondary efficacy endpoints [ Time Frame: 6 weeks, 3 months or 6 months ]
    • comparison of scores in Parts I and II of the UMSARS scale between the visit V0 and V3, i.e. after 6 months of treatment at the dose of 40mg/d
    • comparison of scores in Parts I and II of the UMSARS scale between the visit V0 and V1, i.e. after 6 weeks of treatment at the dose of 20mg/d
    • rate of mortality
    • score of SCOPA AUT scale - assessment of symptomes related to the dysautonomic affect
    • score of Part III of UMSARS scale - assessment of orthostatic hypotension
    • score of Beck scale - assessment of depression
    • score of Schrag scale - assessment of health-related quality of life

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146548

hospital center of Aix enProvence
Aix en Provence, France
Hospital Gabriel Montpied
Clermont-Ferrand, France
University Hospital Henri Mondor
Creteil, France
Dijon, France
Hospital R Salengro
Lille, France
university hospital Dupuytren
Limoges, France
university hospital Timone
Marseille, France
University Hospital
Montpellier, France
Nantes, France
hospital Pitié Salpêtrière
Paris, France
University Hospital La Miletrie
Poitiers, France
Hospital Pontchaillou
Rennes, France
civil hospital of Strasbourg
Strasbourg, France
University Hospital
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Clinical Research Center, Toulouse
Principal Investigator: Olivier Rascol, MD Hospital University Toulouse
More Information

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01146548     History of Changes
Other Study ID Numbers: 0720101
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: February 2012

Keywords provided by University Hospital, Toulouse:
Fluoxetine effect
Multiple System Atrophy

Additional relevant MeSH terms:
Multiple System Atrophy
Shy-Drager Syndrome
Autonomic Nervous System Diseases
Nervous System Diseases
Central Nervous System Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Neurodegenerative Diseases
Vascular Diseases
Cardiovascular Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors