Fluoxetine on Motor Rehabilitation After Ischemic Stroke (FLAME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657163
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : September 16, 2011
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
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 or disease Intervention/treatment Phase
Ischemic Stroke Motor Impairment Drug: fluoxetine Drug: placebo Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial
Study Start Date : March 2005
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
Drug Information available for: Fluoxetine

Arm Intervention/treatment
Experimental: 1
Drug: fluoxetine
fluoxetine per os 20 mg daily
Other Name: PROZAC

Placebo Comparator: 2
Drug: placebo
placebo per os daily

Primary Outcome Measures :
  1. Progression in the Fugl-Meyer Motor Scale [ Time Frame: M3 (3 months) ]

Secondary Outcome Measures :
  1. Fugl-Meyer Stroke Scale [ Time Frame: M12 (12 months) ]
  2. NIH stroke scale [ Time Frame: M3 and M12 ]
  3. MADRS depression scale [ Time Frame: M3 and M12 ]
  4. Modified Rankin scale [ Time Frame: M3 and M12 ]
  5. Mortality [ Time Frame: M3 and M12 ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women aged from 18 to 85
  • No motor relapse from a previous stroke
  • Inclusion from day 5 to day 10 after stroke
  • Ischemic stroke with unilateral motor deficit
  • Motor NIHSS ≥ 5 on the affected side of the body
  • NIHSS < 20
  • Fugl Meyer Motor Scale <55
  • Modified Rankin Scale between 1 and 5
  • Informed consent obtained from the subject or a member of his family

Exclusion Criteria:

  • Pregnant or breast-feeding woman
  • Woman able to procreate without valid contraception
  • Subject protected by law
  • Concomitant disease with unfavourable prognosis within 1 year
  • Drug addiction
  • Allergy to fluoxetine
  • Hepatic failure (TGO and TGP >2N)
  • Permanent Renal failure (Creatinin >180micromol/l)
  • Patients treated by tricyclic antidepressant, selective serotonin reuptake inhibitor, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month
  • Depression requiring pharmacological treatment
  • Previous stroke with motor relapse
  • Fugl Meyer Motor Scale > 55
  • Modified Rankin Scale = 0 or 6
  • Patients needing carotid surgery within 3 months
  • Aphasia preventing correct evaluation of motor and depression scales.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657163

University Hospital
Besançon, France, 25030
University Hospital René Dubos
Cergy-Pontoise, France, 95303
University Hospital
Dijon, France, 21000
University Hospital
Grenoble, France, 38048
University Hospital
Nantes, France, 44093
University Hospital Pitié Salpétrière
Paris, France, 75651
University Hospital Sainte Anne
Paris, France, 75674
University Hospital Rangueil
Toulouse, France, 31052
University Hospital Purpan
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Principal Investigator: François Chollet, PhD University Hospital, Toulouse

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse Identifier: NCT00657163     History of Changes
Other Study ID Numbers: 0300501
French PHRC
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: September 16, 2011
Last Verified: July 2009

Keywords provided by University Hospital, Toulouse:
Stroke recovery
Pharmacological modulation
Selective Serotonin Reuptake Inhibitor (SSRI)
Brain plasticity
Ischemic Stroke and Motor impairment
Modulation of recovery and cerebral plasticity by Fluoxetine

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Receptor Agonists