Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation

Phase 2

Completed

• Conditions: Multiple Sclerosis; Fatigue
• Interventions: Drug: Placebo; Drug: 3,4-diaminopyridine

• Registration Number: NCT00342381
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Only recruiting from:

Department of Neurology, Aarhus University Hospital, Denmark

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-20
• Study First Submitted QC: 2006-06-20
• Study First Posted: 2006-06-21
• Status Verified: 2007-12
• Study Completion: 2007-12
• Last Update Submitted: 2007-12-12
• Last Update Posted: 2007-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Two tablets identical to active treatment
3.4 diaminopyridine	3,4-diaminopyridine	Single dose 3,4 diaminopyridine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
6 minute walk test	at the time of investigation
Subjective fatigue (MFI-20, Danish version)	Weeks
Rapid voluntary twitches	at the time of investigation
9-hole peg test	at the time of investigation
WAIS/WMS tests	at the time of investigation
WHO-5 Questionnaire	at the time of investigation
Major Depression Inventory	at the time of investigation
Lesion load	at the time of MRI
Whole brain atrophy	at the time of MRI
Subjective fatigue (VAS)	at the time of investigation

Trial Locations

Locations (1)

Aarhus University Hospital, Department of Neurology; 🇩🇰 Aarhus, Denmark