Action of Amantadine on Post-Stroke Aphasic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-04-30

Brief Summary

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The objective of the study is to test the action of the amantadine, as DOPA-agonist, in a double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post stroke aphasic patients.

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Detailed Description

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In France, there are around 30000 aphasic patients. The actual taking care of these patients after stroke includes the treatment of acute stage in stroke unit, followed by rehabilitation program. However, most non fluent aphasic patients remain chronically handicapped despite of intensive logopedic training.

The objective of this clinical project is to test the action of pharmacologic agents on verbal fluency of aphasic patients victims of cerebral infarctions. Only a few studies have been done with various pharmacologic agents, and although the results were not clearly conclusive, they were sufficiently positive for suggesting to launch a well controlled randomized cross-over study.

Then the objective of study is to test the action of the amantadine, as DOPA-agonist, in a double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post stroke aphasic patients.

Conditions

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Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Amantadin - Placebo: 5 amantadin caps - 4 days wash out - 5 placebo caps

5 amantadin caps (100mg); 2 caps a day during 3 days; after wash out period (4 days): 5 placebo caps (2 caps a day during 3 days)

Group Type OTHER

Amantadin

Intervention Type DRUG

Amantadin caps

Placebo

Intervention Type DRUG

Placebo caps

2

Placebo - Amantadin: 5 placebo caps - 4 days wash out - 5 amantadin caps

5 placebo caps: 2 caps a day during 3 days after wash out period (4 days): 5 amantadin caps(100mg) (2 caps a day during 3 days)

Group Type OTHER

Amantadin

Intervention Type DRUG

Amantadin caps

Placebo

Intervention Type DRUG

Placebo caps

Interventions

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Amantadin

Amantadin caps

Intervention Type DRUG

Placebo

Placebo caps

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* RANKIN \< 3
* \> 18 years and \< 75
* francophone
* within cognitive deficit known before stroke
* stroke, single in sylvian artery area
* aphasia " non fluent " following a stroke
* stroke \> six month
* stable treatment

Exclusion Criteria

* RANKIN \> 3
* non francophone
* do not read nor write
* many stroke - against indication
* participated in another clinical trial
* deaf or blind
* intercurrent disease
* new treatment (\< 2 months) cognitive
* pregnant or lactating

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No