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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190268
First received: September 13, 2005
Last updated: February 18, 2011
Last verified: March 2007
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: 3,4-diaminopyridine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group. [ Time Frame: 43 months ] [ Designated as safety issue: Yes ]
    improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.


Secondary Outcome Measures:
  • evaluation of safety [ Time Frame: 43 months ] [ Designated as safety issue: Yes ]
    evaluation of safety

  • quality of life impact [ Time Frame: 43 months ] [ Designated as safety issue: Yes ]
    quality of life impact


Enrollment: 126
Study Start Date: February 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3,4-diaminopyridine
3,4-diaminopyridine
Drug: 3,4-diaminopyridine
3,4-diaminopyridine
Other Name: 3,4-diaminopyridine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190268

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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: February 18, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
multiple sclerosis
fatigue
3,4-diaminopyridine

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
3,4-diaminopyridine
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014