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

Primary Purpose

Cerebral Infarction

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Amantadin
Placebo
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring cerebral infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH Saint Pierre La Réunion
  • University hospital of Bordeaux
  • CHU de Dijon
  • CHU Limoges
  • CHU de Nice
  • CHU Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Codify a drug test to be included in the" recommendations "to take care of these patients
Establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment
Identify extra linguistic components of communication influenced by amantadine

Full Information

First Posted
January 9, 2009
Last Updated
April 18, 2014
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT00821691
Brief Title
Action of Amantadine on Post-Stroke Aphasic Patients
Acronym
CELIC-1
Official Title
Action of the Amantadine on Post Stroke Aphasic Patients' Language and Communication
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
cerebral infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
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)
Arm Title
2
Arm Type
Other
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Amantadin
Intervention Description
Amantadin caps
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo caps
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Codify a drug test to be included in the" recommendations "to take care of these patients
Time Frame
2 years
Title
Establish correlations between clinical, neuroradiological lesions and pharmacological responses, as to argue in favour of long-term treatment
Time Frame
2 years
Title
Identify extra linguistic components of communication influenced by amantadine
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel CHATEL, MDPH
Organizational Affiliation
University hospital of Nice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hélène MAHAGNE, PH
Organizational Affiliation
University hospital of Nice
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sylvain LACHAUD, PH
Organizational Affiliation
University hospital of Nice
Official's Role
Study Director
Facility Information:
Facility Name
CH Saint Pierre La Réunion
City
Saint Pierre
State/Province
Ile de La Réunion
Country
France
Facility Name
University hospital of Bordeaux
City
Bordeaux
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
CHU Limoges
City
Limoges
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
CHU Rennes
City
Rennes
Country
France

12. IPD Sharing Statement

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Action of Amantadine on Post-Stroke Aphasic Patients

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