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

University of Aarhus

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis; Fatigue

Treatments: Drug: 3,4-diaminopyridine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00342381

20060003

Details and patient eligibility

About

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.

Full description

Only recruiting from:

Department of Neurology, Aarhus University Hospital, Denmark

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

3.4 diaminopyridine

Active Comparator group

Description:

Single dose 3,4 diaminopyridine

Treatment:

Drug: 3,4-diaminopyridine

Placebo

Placebo Comparator group

Description:

Two tablets identical to active treatment

Treatment:

Drug: Placebo