NCT00342381

Brief Summary

The purpose of this study is to investigate fatigue in patients with multiple sclerosis (MS) and to determine the correlation between the symptom and cerebral changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 multiple-sclerosis

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

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

June 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 17, 2007

Status Verified

December 1, 2007

First QC Date

June 20, 2006

Last Update Submit

December 12, 2007

Conditions

Multiple SclerosisFatigue

Keywords

Motor fatigueCognitive fatigue

Outcome Measures

Primary Outcomes (6)

  • Subjective fatigue (FSS)

    Weeks

  • Maximal voluntary isometric contraction, central activation before and after exercise

    at the time of investigation

  • Digit Symbol-Coding scores

    Weeks

  • Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters)

    at the time of MRI

  • Cortical atrophy

    at the time of MRI

  • Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine)

    at the time of investigation

Secondary Outcomes (10)

  • Subjective fatigue (MFI-20, Danish version)

    Weeks

  • Rapid voluntary twitches

    at the time of investigation

  • 6 minute walk test

    at the time of investigation

  • 9-hole peg test

    at the time of investigation

  • WAIS/WMS tests

    at the time of investigation

  • +5 more secondary outcomes

Study Arms (2)

3.4 diaminopyridine

ACTIVE COMPARATOR

Single dose 3,4 diaminopyridine

Drug: 3,4-diaminopyridine

Placebo

PLACEBO COMPARATOR

Two tablets identical to active treatment

Drug: Placebo

Interventions

3,4-diaminopyridineDRUG

Single dose 3,4 diaminopyridine

3.4 diaminopyridine
PlaceboDRUG

Single dose placebo treatment

Also known as: n/d
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Relapsing remitting-multiple sclerosis (RR-MS) according to Poser criteria
  • EDSS: max 3.5
  • Right handed
  • Normal function of the right hand

You may not qualify if:

  • Disease interfering with MS
  • Known dementia
  • Drug or alcohol abuse
  • Treatment with psychoactive drugs within one week before study entry
  • Major changes of medical treatment within 3 weeks before study entry
  • Attack within 4 weeks before study entry
  • Pregnancy
  • Conditions interfering with 3,4-diaminopyridine treatment
  • Conditions interfering with MRI
  • Conditions interfering with transcranial magnetic stimulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Neurology

Aarhus, 8000, Denmark

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

  • Henning Andersen, MD, DMSc

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Johannes Jacobsen, Professor

    Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2006

First Posted

June 21, 2006

Study Start

June 1, 2006

Study Completion

December 1, 2007

Last Updated

December 17, 2007

Record last verified: 2007-12

Locations

DK(1)