Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation
This study has been completed.
Sponsor:
University of Aarhus
Collaborator:
The Danish Multiple Sclerosis Society
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00342381
First received: June 20, 2006
Last updated: December 12, 2007
Last verified: December 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis Fatigue |
Drug: 3,4-diaminopyridine Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation |
Resource links provided by NLM:
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- Subjective fatigue (FSS) [ Time Frame: Weeks ] [ Designated as safety issue: No ]
- Maximal voluntary isometric contraction, central activation before and after exercise [ Time Frame: at the time of investigation ] [ Designated as safety issue: No ]
- Digit Symbol-Coding scores [ Time Frame: Weeks ] [ Designated as safety issue: No ]
- Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters) [ Time Frame: at the time of MRI ] [ Designated as safety issue: No ]
- Cortical atrophy [ Time Frame: at the time of MRI ] [ Designated as safety issue: No ]
- Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine) [ Time Frame: at the time of investigation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Subjective fatigue (MFI-20, Danish version) [ Time Frame: Weeks ] [ Designated as safety issue: No ]
- Rapid voluntary twitches [ Time Frame: at the time of investigation ] [ Designated as safety issue: No ]
- 6 minute walk test [ Time Frame: at the time of investigation ] [ Designated as safety issue: No ]
- 9-hole peg test [ Time Frame: at the time of investigation ] [ Designated as safety issue: No ]
- WAIS/WMS tests [ Time Frame: at the time of investigation ] [ Designated as safety issue: No ]
- WHO-5 Questionnaire [ Time Frame: at the time of investigation ] [ Designated as safety issue: No ]
- Major Depression Inventory [ Time Frame: at the time of investigation ] [ Designated as safety issue: No ]
- Lesion load [ Time Frame: at the time of MRI ] [ Designated as safety issue: No ]
- Whole brain atrophy [ Time Frame: at the time of MRI ] [ Designated as safety issue: No ]
- Subjective fatigue (VAS) [ Time Frame: at the time of investigation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2006 |
| Study Completion Date: | December 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 3.4 diaminopyridine
Single dose 3,4 diaminopyridine
|
Drug: 3,4-diaminopyridine
Single dose 3,4 diaminopyridine
|
|
Placebo Comparator: Placebo
Two tablets identical to active treatment
|
Drug: Placebo
Single dose placebo treatment
Other Name: n/d
|
Detailed Description:
Only recruiting from:
Department of Neurology, Aarhus University Hospital, Denmark
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00342381
Locations
| Denmark | |
| Aarhus University Hospital, Department of Neurology | |
| Aarhus, Denmark, 8000 | |
Sponsors and Collaborators
University of Aarhus
The Danish Multiple Sclerosis Society
Investigators
| Principal Investigator: | Henning Andersen, MD, DMSc | Aarhus University Hospital, Aarhus Denmark |
| Study Chair: | Johannes Jacobsen, Professor | Aarhus University Hospital, Aarhus, Denmark |
More Information
No publications provided
| Responsible Party: | Henning Andersen, Dep of neurology, Aarhus University Hospital |
| ClinicalTrials.gov Identifier: | NCT00342381 History of Changes |
| Other Study ID Numbers: | 20060003 |
| Study First Received: | June 20, 2006 |
| Last Updated: | December 12, 2007 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by University of Aarhus:
|
Motor fatigue Cognitive fatigue |
Additional relevant MeSH terms:
|
Fatigue Multiple Sclerosis Sclerosis Signs and Symptoms Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes 3,4-diaminopyridine 4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013