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Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
3,4-diaminopyridine
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, fatigue, 3,4-diaminopyridine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henri Mondor Hospital
  • Pitié Salpetriere Hospital
  • Tenon Hospital
  • Pontchaillou Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3,4-diaminopyridine

Arm Description

3,4-diaminopyridine

Outcomes

Primary Outcome Measures

improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.

Secondary Outcome Measures

evaluation of safety
evaluation of safety
quality of life impact
quality of life impact

Full Information

First Posted
September 13, 2005
Last Updated
February 18, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00190268
Brief Title
Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in patient's multiple sclerosis. In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded study is performed.
Detailed Description
We proposed a randomized controlled trial between 3,4-diaminopyridine and placebo . The main objective : improvement of fatigue by diminution of EMIF-SEP score between the arm treatment and placebo arm. The hypothesis tested is that the 3,4-DAP is efficacy in the fatigue of multiple sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, fatigue, 3,4-diaminopyridine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3,4-diaminopyridine
Arm Type
Experimental
Arm Description
3,4-diaminopyridine
Intervention Type
Drug
Intervention Name(s)
3,4-diaminopyridine
Intervention Description
3,4-diaminopyridine
Primary Outcome Measure Information:
Title
improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
Description
improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
Time Frame
43 months
Secondary Outcome Measure Information:
Title
evaluation of safety
Description
evaluation of safety
Time Frame
43 months
Title
quality of life impact
Description
quality of life impact
Time Frame
43 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Cesaro, MD
Organizational Affiliation
Hopital Henri Mondor-France
Official's Role
Study Chair
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Pitié Salpetriere Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Tenon Hospital
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Pontchaillou Hospital
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis

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