Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00190268 |
Date of registration:
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13/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis
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Scientific title:
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Multicentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis |
Date of first enrolment:
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February 2005 |
Target sample size:
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126 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00190268 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Pierre Cesaro, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Henri Mondor-France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age >= 18 years and = <60 years
- Patients with multiple sclerosis clinically defined and with MIFS-SEP score > 44,
without deficit sleep and without depression.
- Patients without treatment by 3,4-DAP since 3 months
- EDSS score < 6
Exclusion Criteria:
- ASAT/ALAT > 2 x ULN
- MADRS >= 20
- Abnormality cardiac rhythm
- Pregnancy
- Asthma
- Evolutive affection
- Renal failure
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: 3,4-diaminopyridine
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Primary Outcome(s)
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improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
[Time Frame: 43 months]
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Secondary Outcome(s)
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evaluation of safety
[Time Frame: 43 months]
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quality of life impact
[Time Frame: 43 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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