Action of Amantadine on Post-Stroke Aphasic Patients (CELIC-1)

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Infarction
• Intervention / Treatment: Drug: Amantadin; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • University Hospital of Bordeaux
  • Dijon, France
    • CHU de Dijon
  • Limoges, France
    • CHU Limoges
  • Nice, France, 06000
    • Chu de Nice
  • Rennes, France
    • CHU Rennes
  • Ile de La Réunion
    • Saint Pierre, Ile de La Réunion, France
      • CH Saint Pierre La Réunion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)	Drug: Amantadin; Amantadin caps; Drug: Placebo; Placebo caps
Other: 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)	Drug: Amantadin; Amantadin caps; Drug: Placebo; Placebo caps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Marcel CHATEL, MDPH, University Hospital of Nice; Study Director: Hélène MAHAGNE, PH, University Hospital of Nice; Study Director: Sylvain LACHAUD, PH, University Hospital of Nice

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 9, 2009
• First Submitted That Met QC Criteria: January 12, 2009
• First Posted (Estimate): January 13, 2009

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 18, 2014
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: cerebral infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Cerebral Infarction
• Other Study ID Numbers: 01-APN-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No