Fluoxetine in Multiple System Atrophy Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT01146548
• Date of registration: 16/06/2010
• Prospective Registration: No
• Primary sponsor: University Hospital, Toulouse
• Public title: Fluoxetine in Multiple System Atrophy Patients MSA-Fluox
• Scientific title: Assessment of Fluoxetine's Effect in Patients With Multiple System Atrophy : a Double Blind Placebo-controlled Randomized Trial
• Date of first enrolment: May 2008
• Target sample size: 87
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01146548
• 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
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Olivier Rascol, MD
• Affiliation: Hospital University Toulouse

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple System Atrophy

Intervention(s)

Drug: FLUOXETINE

Primary Outcome(s)

primary efficacy endpoint [Time Frame: 3 months]

Secondary Outcome(s)

secondary efficacy endpoints [Time Frame: 6 weeks, 3 months or 6 months]

Secondary ID(s)

0720101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Clinical Research Center, Toulouse