Action of Amantadine on Post-Stroke Aphasic Patients
CELIC-1
Action of the Amantadine on Post Stroke Aphasic Patients' Language and Communication
1 other identifier
interventional
50
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2009
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2009
CompletedFirst Posted
Study publicly available on registry
January 13, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedApril 21, 2014
June 1, 2013
4.1 years
January 9, 2009
April 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
2 years
Secondary Outcomes (3)
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
Study Arms (2)
1
OTHERAmantadin - 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)
2
OTHERPlacebo - 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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, 06000, France
CHU Rennes
Rennes, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2009
First Posted
January 13, 2009
Study Start
March 1, 2009
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
April 21, 2014
Record last verified: 2013-06