Action of Amantadine on Post-Stroke Aphasic Patients

Study Overview
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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.

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.

Official Title
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Action of the Amantadine on Post Stroke Aphasic Patients' Language and Communication

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Drug: Amantadin
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>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) | Drug: Amantadin<br>* Amantadin caps<br>Drug: Placebo<br>* Placebo caps<br>|
| Other: 2<br>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) | Drug: Amantadin<br>* Amantadin caps<br>Drug: Placebo<br>* Placebo caps<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirm that the possibility of significantly improving the verbal fluency and communication of patients with not fluent aphasia at the chronic stage when logopedic rehabilitation is stabilized (> 6months). |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Codify a drug test to be included in the recommendations to take care of these patients |  | 2 years | 
| Establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment |  | 2 years | 
| Identify extra linguistic components of communication influenced by amantadine |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral infarction