Fluoxetine in Multiple System Atrophy Patients (MSA-Fluox)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01146548
First received: June 16, 2010
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Multiple System Atrophy
Drug: FLUOXETINE
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • primary efficacy endpoint [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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:
  • secondary efficacy endpoints [ Time Frame: 6 weeks, 3 months or 6 months ] [ Designated as safety issue: Yes ]
    • 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


Enrollment: 87
Study Start Date: May 2008
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: the fluoxetine group
Multiple System Atrophy's patients with fluoxétine
Drug: FLUOXETINE
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
Drug: FLUOXETINE
20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.
Other Name: PROZAC®

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146548

Locations
France
hospital center of Aix enProvence
Aix en Provence, France
Hospital Gabriel Montpied
Clermont-Ferrand, France
University Hospital Henri Mondor
Creteil, France
Hopital
Dijon, France
Hospital R Salengro
Lille, France
university hospital Dupuytren
Limoges, France
university hospital Timone
Marseille, France
University Hospital
Montpellier, France
Hospital
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
Investigators
Principal Investigator: Olivier Rascol, MD Hospital University Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01146548     History of Changes
Other Study ID Numbers: 0720101
Study First Received: June 16, 2010
Last Updated: February 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014