NCT00190268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P25-P50 for phase_3 multiple-sclerosis

Timeline
Completed

Started Feb 2005

Typical duration for phase_3 multiple-sclerosis

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 21, 2011

Status Verified

March 1, 2007

Enrollment Period

3.3 years

First QC Date

September 13, 2005

Last Update Submit

February 18, 2011

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisfatigue3,4-diaminopyridine

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • evaluation of safety

    43 months

  • quality of life impact

    43 months

Study Arms (1)

3,4-diaminopyridine

EXPERIMENTAL

3,4-diaminopyridine

Drug: 3,4-diaminopyridine

Interventions

3,4-diaminopyridineDRUG

3,4-diaminopyridine

3,4-diaminopyridine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • ASAT/ALAT \> 2 x ULN
  • MADRS \>= 20
  • Abnormality cardiac rhythm
  • Pregnancy
  • Asthma
  • Evolutive affection
  • Renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Henri Mondor Hospital

Créteil, 94010, France

Location

Pitié Salpetriere Hospital

Paris, 75013, France

Location

Tenon Hospital

Paris, 75020, France

Location

Pontchaillou Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

Multiple SclerosisFatigue

Interventions

Amifampridine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-AminopyridineAminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pierre Cesaro, MD

    Hopital Henri Mondor-France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

February 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 21, 2011

Record last verified: 2007-03

Locations

FR(4)