Fluoxetine on Motor Rehabilitation After Ischemic Stroke - Full Text View

Sponsor:	University Hospital, Toulouse
Information provided by:	University Hospital, Toulouse
ClinicalTrials.gov Identifier:	NCT00657163

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

Drug Information available for: Serotonin Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:

Progression in the Fugl-Meyer Motor Scale [ Time Frame: M3 (3 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fugl-Meyer Stroke Scale [ Time Frame: M12 (12 months) ] [ Designated as safety issue: No ]
NIH stroke scale [ Time Frame: M3 and M12 ] [ Designated as safety issue: No ]
MADRS depression scale [ Time Frame: M3 and M12 ] [ Designated as safety issue: No ]
Modified Rankin scale [ Time Frame: M3 and M12 ] [ Designated as safety issue: No ]
Mortality [ Time Frame: M3 and M12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	March 2005
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657163

Locations

France
University Hospital Purpan
Toulouse, France, 31059
University Hospital
Besançon, France, 25030
University Hospital
Dijon, France, 21000
University Hospital
Grenoble, France, 38048
University Hospital Rangueil
Toulouse, France, 31052
University Hospital Sainte Anne
Paris, France, 75674
University Hospital Pitié Salpétrière
Paris, France, 75651
University Hospital René Dubos
Cergy-Pontoise, France, 95303
University Hospital
Nantes, France, 44093

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator:

François Chollet, PhD

University Hospital, Toulouse

More Information

Publications:

Pariente J, Loubinoux I, Carel C, Albucher JF, Leger A, Manelfe C, Rascol O, Chollet F. Fluoxetine modulates motor performance and cerebral activation of patients recovering from stroke. Ann Neurol. 2001 Dec;50(6):718-29.

Dam M, Tonin P, De Boni A, Pizzolato G, Casson S, Ermani M, Freo U, Piron L, Battistin L. Effects of fluoxetine and maprotiline on functional recovery in poststroke hemiplegic patients undergoing rehabilitation therapy. Stroke. 1996 Jul;27(7):1211-4.

Responsible Party:	University Hospital Toulouse ( LLAU Marie-Elise )
Study ID Numbers:	0300501, French PHRC
Study First Received:	April 8, 2008
Last Updated:	July 16, 2009
ClinicalTrials.gov Identifier:	NCT00657163 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Toulouse:

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

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cerebral Infarction
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Brain Diseases
Cerebrovascular Disorders
Pathologic Processes
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Antidepressive Agents, Second-Generation

Antidepressive Agents
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Serotonin Uptake Inhibitors
Pharmacologic Actions
Fluoxetine
Serotonin Agents
Brain Infarction
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009