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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014