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

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ClinicalTrials.gov Identifier: NCT00342381
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : December 17, 2007
Sponsor:
Collaborator:
The Danish Multiple Sclerosis Society
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Fatigue Drug: 3,4-diaminopyridine Drug: Placebo Phase 2

Detailed Description:

Only recruiting from:

Department of Neurology, Aarhus University Hospital, Denmark


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation
Study Start Date : June 2006
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Subjective fatigue (FSS) [ Time Frame: Weeks ]
  2. Maximal voluntary isometric contraction, central activation before and after exercise [ Time Frame: at the time of investigation ]
  3. Digit Symbol-Coding scores [ Time Frame: Weeks ]
  4. Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters) [ Time Frame: at the time of MRI ]
  5. Cortical atrophy [ Time Frame: at the time of MRI ]
  6. Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine) [ Time Frame: at the time of investigation ]

Secondary Outcome Measures :
  1. Subjective fatigue (MFI-20, Danish version) [ Time Frame: Weeks ]
  2. Rapid voluntary twitches [ Time Frame: at the time of investigation ]
  3. 6 minute walk test [ Time Frame: at the time of investigation ]
  4. 9-hole peg test [ Time Frame: at the time of investigation ]
  5. WAIS/WMS tests [ Time Frame: at the time of investigation ]
  6. WHO-5 Questionnaire [ Time Frame: at the time of investigation ]
  7. Major Depression Inventory [ Time Frame: at the time of investigation ]
  8. Lesion load [ Time Frame: at the time of MRI ]
  9. Whole brain atrophy [ Time Frame: at the time of MRI ]
  10. Subjective fatigue (VAS) [ Time Frame: at the time of investigation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Henning Andersen, Dep of neurology, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00342381     History of Changes
Other Study ID Numbers: 20060003
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: December 17, 2007
Last Verified: December 2007

Keywords provided by University of Aarhus:
Motor fatigue
Cognitive fatigue

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
3,4-diaminopyridine
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action