Efficacy of 3,4-DAP in Fatigue Associated With Multiple S... | NCT00190268

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

NCT00190268

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Feb 21, 2011Estimated

Enrollment

126Actual

Phase

Phase 3

Conditions

Multiple Sclerosis

Interventions

3,4-diaminopyridine

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2011

Last Update Posted Date

Feb 21, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3,4-diaminopyridine	Experimental	3,4-diaminopyridine	Drug: 3,4-diaminopyridine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3,4-diaminopyridine	Drug	3,4-diaminopyridine	3,4-diaminopyridine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
evaluation of safety	evaluation of safety	43 months
quality of life impact	quality of life impact	43 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Cesaro, MD	Hopital Henri Mondor-France	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henri Mondor Hospital		Créteil		94010	France
Pitié Salpetriere Hospital

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D005221	Fatigue

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077770	Amifampridine

Ancestor Terms

ID	Term
D015761	4-Aminopyridine
D000631	Aminopyridines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided