Multiple System Atrophy Clinical Trial
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03593512 -
Deep Brain Stimulation for Autonomic and Gait Symptoms in Multiple System Atrophy
|
N/A | |
| Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
| Active, not recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
| Recruiting |
NCT02897063 -
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
|
Phase 1 | |
| Not yet recruiting |
NCT00758849 -
Fipamezole in Neurogenic Orthostatic Hypotension
|
Phase 2 | |
| Completed |
NCT01155492 -
Increased Gut Permeability to Lipopolysaccharides (LPS) in Parkinson's Disease
|
N/A | |
| Recruiting |
NCT04431713 -
Exenatide Once-weekly as a Treatment for Multiple System Atrophy
|
Phase 2 | |
| Completed |
NCT04184063 -
Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA)
|
Phase 2 | |
| Recruiting |
NCT05121012 -
Synaptic Loss in Multiple System Atrophy
|
||
| Terminated |
NCT03589976 -
A Futility Trial of Sirolimus in Multiple System Atrophy
|
Phase 2 | |
| Recruiting |
NCT04706234 -
Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies
|
||
| Completed |
NCT00368199 -
Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes
|
N/A | |
| Recruiting |
NCT04472130 -
Neurodegenerative Diseases Registry
|
||
| Recruiting |
NCT04876326 -
Potential Use of Autologous and Allogeneic Mesenchymal Stem Cells in Patients With Multiple System Atrophy
|
N/A | |
| Recruiting |
NCT04680065 -
GDNF Gene Therapy for Multiple System Atrophy
|
Phase 1 | |
| Completed |
NCT03753763 -
Safinamide for Multiple System Atrophy (MSA)
|
Phase 2 | |
| Recruiting |
NCT04250493 -
Insulin Resistance in Multiple System Atrophy
|
N/A | |
| Recruiting |
NCT06072105 -
Medical Decision Making in Multiple System Atrophy
|
N/A | |
| Terminated |
NCT02149901 -
Water and Sudafed in Autonomic Failure
|
Early Phase 1 | |
| Terminated |
NCT00997672 -
Lithium in Multiple System Atrophy
|
Phase 2 |