Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University Hospital, Toulouse |
---|---|
Information provided by: | University Hospital, Toulouse |
ClinicalTrials.gov Identifier: | NCT00657163 |
Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.
Condition | Intervention | Phase |
---|---|---|
Ischemic Stroke Motor Impairment |
Drug: fluoxetine Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial |
Estimated Enrollment: | 100 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
fluoxetine
|
Drug: fluoxetine
fluoxetine per os 20 mg daily
|
2: Placebo Comparator
Placebo
|
Drug: placebo
placebo per os daily
|
We project to include in the study a maximum of 168 patients with a recent (5 to 10 days) ischemic stroke and unilateral motor deficit in order to obtain 100 completed patients. Nine stroke centers in France are involved.
Each patient will receive daily, during three months, 20 mg of fluoxetin or placebo.
Patients will be evaluated at inclusion, day 30, M3 (3 months), M12.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: François CHOLLET, PhD | chollet.f@chu-toulouse.fr |
France | |
University Hospital Purpan | Recruiting |
Toulouse, France, 31059 | |
Principal Investigator: François Chollet, MD | |
Sub-Investigator: Jean Tardy, MD | |
Sub-Investigator: Jean-François Albucher | |
University Hospital | Recruiting |
Besançon, France, 25030 | |
Principal Investigator: Thierry Moulin | |
University Hospital | Recruiting |
Dijon, France, 21000 | |
Principal Investigator: Maurice Giroud | |
University Hospital | Recruiting |
Grenoble, France, 38048 | |
Principal Investigator: Marc Hommel | |
University Hospital Rangueil | Recruiting |
Toulouse, France, 31052 | |
Principal Investigator: Vincent Larrue | |
Sub-Investigator: Jean Tardy, MD | |
University Hospital Sainte Anne | Recruiting |
Paris, France, 75674 | |
Principal Investigator: Jean-Louis MAS | |
University Hospital Pitié Salpétrière | Recruiting |
Paris, France, 75651 | |
Principal Investigator: Yves Samson | |
University Hospital René Dubos | Recruiting |
Cergy-Pontoise, France, 95303 | |
Principal Investigator: Jérome Servan | |
University Hospital | Recruiting |
Nantes, France, 44093 | |
Principal Investigator: Benoit Guillon |
Principal Investigator: | François Chollet, PhD | University Hospital, Toulouse |
Responsible Party: | University Hospital Toulouse ( LLAU Marie-Elise ) |
Study ID Numbers: | 0300501, French PHRC |
Study First Received: | April 8, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00657163 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Stroke recovery Pharmacological modulation Selective Serotonin Reuptake Inhibitor (SSRI) Fluoxetine |
Brain plasticity Ischemic Stroke and Motor impairment Modulation of recovery and cerebral plasticity by Fluoxetine |
Fluoxetine Cerebral Infarction Stroke Vascular Diseases Brain Ischemia Central Nervous System Diseases |
Brain Infarction Ischemia Brain Diseases Infarction Cerebrovascular Disorders Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions |
Pathologic Processes Serotonin Agents Therapeutic Uses Cardiovascular Diseases Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |