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

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: NCT00190268
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 21, 2011
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: 3,4-diaminopyridine Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2005
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 3,4-diaminopyridine
Drug: 3,4-diaminopyridine

Primary Outcome Measures :
  1. improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group. [ Time Frame: 43 months ]
    improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.

Secondary Outcome Measures :
  1. evaluation of safety [ Time Frame: 43 months ]
    evaluation of safety

  2. quality of life impact [ Time Frame: 43 months ]
    quality of life impact

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00190268

Henri Mondor Hospital
Creteil, France, 94010
Pitié Salpetriere Hospital
Paris, France, 75013
Tenon Hospital
Paris, France, 75020
Pontchaillou Hospital
Rennes, France, 35000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Study Chair: Pierre Cesaro, MD Hopital Henri Mondor-France

Responsible Party: Isabelle BRINDEL, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00190268     History of Changes
Obsolete Identifiers: NCT00169429
Other Study ID Numbers: P020304
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action