Multiple System AtrophyPhase 2MSA-FluoxNCT01146548
Fluoxetine in Multiple System Atrophy Patients
A Phase 2 study testing FLUOXETINE in people with Multiple System Atrophy, run by University Hospital, Toulouse at 14 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- FLUOXETINE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 14 sitesFrance
- Study dates
- May 2008to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
hospital center of Aix enProvence
Aix-en-Provence
Hospital Gabriel Montpied
Clermont-Ferrand
University Hospital Henri Mondor
Créteil
Hopital
Dijon
Hospital R Salengro
Lille
university hospital Dupuytren
Limoges
university hospital Timone
Marseille
University Hospital
Montpellier
Hospital
Nantes, France
hospital Pitié Salpêtrière
Paris
University Hospital La Miletrie
Poitiers
Hospital Pontchaillou
Rennes
civil hospital of Strasbourg
Strasbourg
University Hospital
Toulouse, 31000
About this study
Official title: Assessment of Fluoxetine's Effect in Patients With Multiple System Atrophy : a Double Blind Placebo-controlled Randomized Trial
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.
Read the 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.
- Conditions
- Multiple System Atrophy
- Being tested
- FLUOXETINE
- Keywords
- Fluoxetine effect, Multiple System Atrophy, MSA
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLUOXETINEDrug
Also called PROZAC®
20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| the fluoxetine group | Experimental | Multiple System Atrophy's patients with fluoxétine Receives: Drug: FLUOXETINE |
| the placebo group | Placebo comparator | Multiple System Atrophy's patients with placebo Receives: Drug: FLUOXETINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (1)
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
Measured: 6 weeks, 3 months or 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startMay 2008
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research Center, Toulouse
- Responsible party
- Sponsor
- Investigators
- Olivier Rascol, MD, Principal investigator, Hospital University Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146548
- Sponsor's protocol ID
- 0720101
- Acronym
- MSA-Fluox
- Status last verified
- Feb 2012
- First submitted
- 16 Jun 2010
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fluoxetine's Effect in Patients With Multiple System Atrophy : a Double Blind Placebo-controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT01146548
- Acronym / sponsor ID
- MSA-Fluox / 0720101
- Conditions
- Multiple System Atrophy
- Keywords
- Fluoxetine effect, Multiple System Atrophy, MSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Clinical Research Center, Toulouse
- Study start
- May 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the fluoxetine group | Experimental | Drug: FLUOXETINEMultiple System Atrophy's patients with fluoxétine |
| the placebo group | Placebo comparator | Drug: FLUOXETINEMultiple System Atrophy's patients with placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLUOXETINEAlso: PROZAC®20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months. | Drug | the fluoxetine group, the placebo group |
Primary outcome
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).
1 secondary outcome
secondary efficacy endpoints
Time frame: 6 weeks, 3 months or 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Rascol, MD principal investigator
Hospital University Toulouse
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FLUOXETINE in people with Multiple System Atrophy, run by University Hospital, Toulouse at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary efficacy endpoint (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.