ACTION OF THE AMANTADINE ON POST STROKE APHASIC PATIENTS LANGUAGE AND COMMUNICATION - CELIC-1

Phase 1

• Conditions: post stroke chronic aphasia patients

• Registration Number: EUCTR2008-003945-10-FR
• Lead Sponsor: Centre hospitalier universitaire de nice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-12
• Study Completion: 2014-04-04
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- RANKIN <3
- >18 years and < 75
- francophone
- sans déficit cognitif connu avant l'AVC.
- stroke, single dans le territoire de l’artère sylvienne (territoire antérieur ou territoire profond, ou les deux)
- aphasia « non fluent » following a stroke
- stroke > six month
- stable treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 (<2mois) cognitives.
- pregnant or lactating

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm by a «drug test, using amantadine as dopamine agonist, 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).;Secondary Objective: to codify a drug test to be included in the recommendations to take care of these patients. <br>- to establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment. <br>- to identify extra linguistic components of communication influenced by the amantadine.<br>;Primary end point(s): number of correctly enonce by patient during fluence verbale test.