Fluoxetine in Multiple System Atrophy Patients

NCT01146548 | Completed Phase 2

• 1 other identifier: 0720101
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 14

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.

Conditions

Multiple System Atrophy

Keywords

Fluoxetine effect; Multiple System Atrophy; MSA

Outcome Measures

Primary Outcomes (1)

• primary efficacy endpoint

  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).

  3 months

Secondary Outcomes (1)

• secondary efficacy endpoints

  6 weeks, 3 months or 6 months

Study Arms (2)

the fluoxetine group

EXPERIMENTAL

Multiple System Atrophy's patients with fluoxétine

Drug: FLUOXETINE

the placebo group

PLACEBO COMPARATOR

Multiple System Atrophy's patients with placebo

Drug: FLUOXETINE

Interventions

FLUOXETINE DRUG

20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.

Also known as: PROZAC®

the fluoxetine group; the placebo group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Clinical Research Center, Toulouse: collaborator

Study Sites (14)

Hospital

Nantes, France, France

Location

hospital center of Aix enProvence

Aix-en-Provence, France

Location

Hospital Gabriel Montpied

Clermont-Ferrand, France

Location

University Hospital Henri Mondor

Créteil, France

Location

Hopital

Dijon, France

Location

Hospital R Salengro

Lille, France

Location

university hospital Dupuytren

Limoges, France

Location

university hospital Timone

Marseille, France

Location

University Hospital

Montpellier, France

Location

hospital Pitié Salpêtrière

Paris, France

Location

University Hospital La Miletrie

Poitiers, France

Location

Hospital Pontchaillou

Rennes, France

Location

civil hospital of Strasbourg

Strasbourg, France

Location

University Hospital

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Multiple System Atrophy

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Olivier Rascol, MD

  Hospital University Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 17, 2010
• Study Start: May 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 26, 2015

Record last verified: 2012-02

Locations

FR (14)