Fluoxetine in Multiple System Atrophy Patients (MSA-Fluox)
Primary Purpose
Multiple System Atrophy
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FLUOXETINE
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple System Atrophy focused on measuring Fluoxetine effect, Multiple System Atrophy, MSA
Eligibility 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
Sites / Locations
- hospital center of Aix enProvence
- Hospital Gabriel Montpied
- University Hospital Henri Mondor
- Hopital
- Hospital R Salengro
- university hospital Dupuytren
- university hospital Timone
- University Hospital
- Hospital
- hospital Pitié Salpêtrière
- University Hospital La Miletrie
- Hospital Pontchaillou
- civil hospital of Strasbourg
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
the fluoxetine group
the placebo group
Arm Description
Multiple System Atrophy's patients with fluoxétine
Multiple System Atrophy's patients with placebo
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
secondary efficacy endpoints
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
Full Information
NCT ID
NCT01146548
First Posted
June 16, 2010
Last Updated
March 25, 2015
Sponsor
University Hospital, Toulouse
Collaborators
Clinical Research Center, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT01146548
Brief Title
Fluoxetine in Multiple System Atrophy Patients
Acronym
MSA-Fluox
Official Title
Assessment of Fluoxetine's Effect in Patients With Multiple System Atrophy : a Double Blind Placebo-controlled Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Clinical Research Center, Toulouse
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy
Keywords
Fluoxetine effect, Multiple System Atrophy, MSA
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the fluoxetine group
Arm Type
Experimental
Arm Description
Multiple System Atrophy's patients with fluoxétine
Arm Title
the placebo group
Arm Type
Placebo Comparator
Arm Description
Multiple System Atrophy's patients with placebo
Intervention Type
Drug
Intervention Name(s)
FLUOXETINE
Other Intervention Name(s)
PROZAC®
Intervention Description
20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.
Primary Outcome Measure Information:
Title
primary efficacy endpoint
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
secondary efficacy endpoints
Description
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
Time Frame
6 weeks, 3 months or 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Rascol, MD
Organizational Affiliation
Hospital University Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
hospital center of Aix enProvence
City
Aix en Provence
Country
France
Facility Name
Hospital Gabriel Montpied
City
Clermont-Ferrand
Country
France
Facility Name
University Hospital Henri Mondor
City
Creteil
Country
France
Facility Name
Hopital
City
Dijon
Country
France
Facility Name
Hospital R Salengro
City
Lille
Country
France
Facility Name
university hospital Dupuytren
City
Limoges
Country
France
Facility Name
university hospital Timone
City
Marseille
Country
France
Facility Name
University Hospital
City
Montpellier
Country
France
Facility Name
Hospital
City
Nantes
Country
France
Facility Name
hospital Pitié Salpêtrière
City
Paris
Country
France
Facility Name
University Hospital La Miletrie
City
Poitiers
Country
France
Facility Name
Hospital Pontchaillou
City
Rennes
Country
France
Facility Name
civil hospital of Strasbourg
City
Strasbourg
Country
France
Facility Name
University Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
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Fluoxetine in Multiple System Atrophy Patients
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