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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190268
• Other study ID #: P020304
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: February 18, 2011
• Start date: February 2005
• Est. completion date: June 2008

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00169429

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 3,4-diaminopyridine
3,4-diaminopyridine

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil
France	Pitié Salpetriere Hospital	Paris
France	Tenon Hospital	Paris
France	Pontchaillou Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	43 months	Yes
Secondary	evaluation of safety	evaluation of safety	43 months	Yes
Secondary	quality of life impact	quality of life impact	43 months	Yes