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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821691
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Drug: Amantadin Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Action of the Amantadine on Post Stroke Aphasic Patients' Language and Communication
Study Start Date : March 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013
Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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). [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Codify a drug test to be included in the" recommendations "to take care of these patients [ Time Frame: 2 years ]
  2. Establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment [ Time Frame: 2 years ]
  3. Identify extra linguistic components of communication influenced by amantadine [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821691


Locations
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France
CH Saint Pierre La Réunion
Saint Pierre, Ile de La Réunion, France
University hospital of Bordeaux
Bordeaux, France
CHU de Dijon
Dijon, France
CHU Limoges
Limoges, France
CHU de Nice
Nice, France, 06000
CHU Rennes
Rennes, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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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
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00821691    
Other Study ID Numbers: 01-APN-08
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: June 2013
Keywords provided by Centre Hospitalier Universitaire de Nice:
cerebral infarction
Additional relevant MeSH terms:
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Cerebral Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases