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

NCT ID: NCT00342381

Last Updated: 2007-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-12-31

Brief Summary

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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

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Only recruiting from:

Department of Neurology, Aarhus University Hospital, Denmark

Conditions

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Multiple Sclerosis Fatigue

Keywords

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Motor fatigue Cognitive fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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3.4 diaminopyridine

Single dose 3,4 diaminopyridine

Group Type ACTIVE_COMPARATOR

3,4-diaminopyridine

Intervention Type DRUG

Single dose 3,4 diaminopyridine

Placebo

Two tablets identical to active treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose placebo treatment

Interventions

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3,4-diaminopyridine

Single dose 3,4 diaminopyridine

Intervention Type DRUG

Placebo

Single dose placebo treatment

Intervention Type DRUG

Other Intervention Names

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n/d

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Danish Multiple Sclerosis Society

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Dep of neurology, Aarhus University Hospital

Principal Investigators

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Henning Andersen, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Johannes Jacobsen, Professor

Role: STUDY_CHAIR

Aarhus University Hospital

Locations

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Aarhus University Hospital, Department of Neurology

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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20060003

Identifier Type: -

Identifier Source: org_study_id