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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00342381
• Other study ID #: 20060003
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2006
• Last updated: December 12, 2007
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Only recruiting from:

Department of Neurology, Aarhus University Hospital, Denmark

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 3,4-diaminopyridine
Single dose 3,4 diaminopyridine
• Placebo
Single dose placebo treatment

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Neurology	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Danish Multiple Sclerosis Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective fatigue (FSS)		Weeks	No
Primary	Maximal voluntary isometric contraction, central activation before and after exercise		at the time of investigation	No
Primary	Digit Symbol-Coding scores		Weeks	No
Primary	Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters)		at the time of MRI	No
Primary	Cortical atrophy		at the time of MRI	No
Primary	Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine)		at the time of investigation	No
Secondary	Subjective fatigue (MFI-20, Danish version)		Weeks	No
Secondary	Rapid voluntary twitches		at the time of investigation	No
Secondary	6 minute walk test		at the time of investigation	No
Secondary	9-hole peg test		at the time of investigation	No
Secondary	WAIS/WMS tests		at the time of investigation	No
Secondary	WHO-5 Questionnaire		at the time of investigation	No
Secondary	Major Depression Inventory		at the time of investigation	No
Secondary	Lesion load		at the time of MRI	No
Secondary	Whole brain atrophy		at the time of MRI	No
Secondary	Subjective fatigue (VAS)		at the time of investigation	No