Action of Amantadine on Post-Stroke Aphasic Patients

Cerebral Infarction Clinical Trial

— CELIC-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821691
• Other study ID #: 01-APN-08
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 9, 2009
• Last updated: April 18, 2014
• Start date: March 2009
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Centre Hospitalier Universitaire de Nice
• 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

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• Amantadin
Amantadin caps
• Placebo
Placebo caps

Locations

Country	Name	City	State
France	University hospital of Bordeaux	Bordeaux
France	CHU de Dijon	Dijon
France	CHU Limoges	Limoges
France	CHU de Nice	Nice
France	CHU Rennes	Rennes
France	CH Saint Pierre La Réunion	Saint Pierre	Ile de La Réunion

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Codify a drug test to be included in the" recommendations "to take care of these patients		2 years	No
Secondary	Establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment		2 years	No
Secondary	Identify extra linguistic components of communication influenced by amantadine		2 years	No