Fluoxetine on Motor Rehabilitation After Ischemic Stroke

Ischemic Stroke Clinical Trial

— FLAME  

Official title:

Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657163
• Other study ID #: 0300501
• Secondary ID: French PHRC
• Status: Completed
• Phase: Phase 2
• First received: April 8, 2008
• Last updated: September 15, 2011
• Start date: March 2005
• Est. completion date: December 2010

Study information

• Verified date: July 2009
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Motor Impairment
• Stroke

Intervention

Drug:
• fluoxetine
fluoxetine per os 20 mg daily
• placebo
placebo per os daily

Locations

Country	Name	City	State
France	University Hospital	Besançon
France	University Hospital René Dubos	Cergy-Pontoise
France	University Hospital	Dijon
France	University Hospital	Grenoble
France	University Hospital	Nantes
France	University Hospital Pitié Salpétrière	Paris
France	University Hospital Sainte Anne	Paris
France	University Hospital Purpan	Toulouse
France	University Hospital Rangueil	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression in the Fugl-Meyer Motor Scale		M3 (3 months)	No
Secondary	Fugl-Meyer Stroke Scale		M12 (12 months)	No
Secondary	NIH stroke scale		M3 and M12	No
Secondary	MADRS depression scale		M3 and M12	No
Secondary	Modified Rankin scale		M3 and M12	No
Secondary	Mortality		M3 and M12	Yes