Fluoxetine on Motor Rehabilitation After Ischemic Stroke | NCT00657163

Studies
Fluoxetine on Motor Rehabilitation After Ischemic Stroke

NCT00657163

Sponsor

University Hospital, Toulouse

Status

Completed

Last Update Posted

Sep 16, 2011Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Ischemic Stroke
Motor Impairment

Interventions

fluoxetine
placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
French PHRC

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Apr 8, 2008

First Submission Date that Met QC Criteria

Apr 11, 2008

First Posted Date

Apr 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2011

Last Update Posted Date

Sep 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	fluoxetine	Drug: fluoxetine
2	Placebo Comparator	Placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fluoxetine	Drug	fluoxetine per os 20 mg daily	1	PROZAC

Measure	Description	Time Frame
Progression in the Fugl-Meyer Motor Scale		M3 (3 months)

Measure	Description	Time Frame
Fugl-Meyer Stroke Scale		M12 (12 months)
NIH stroke scale		M3 and M12
MADRS depression scale

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François Chollet, PhD	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Besançon		25030	France
University Hospital René Dubos

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11761469	Background	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. doi: 10.1002/ana.1257.
8685930	Background	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. doi: 10.1161/01.str.27.7.1211.

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals