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OpenTrials
Completed

NCT Number: NCT00190268

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Henri Mondor Hospital, Créteil, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3,4-diaminopyridine

Drug

3,4-diaminopyridine

Primary outcomes

  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 outcomes

  1. evaluation of safety

    Time frame: 43 months

    evaluation of safety

  2. quality of life impact

    Time frame: 43 months

    quality of life impact

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Feb 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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