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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014