This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, 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 ]
  • Maximal voluntary isometric contraction, central activation before and after exercise [ Time Frame: at the time of investigation ]
  • Digit Symbol-Coding scores [ Time Frame: Weeks ]
  • Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters) [ Time Frame: at the time of MRI ]
  • Cortical atrophy [ Time Frame: at the time of MRI ]
  • Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine) [ Time Frame: at the time of investigation ]

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

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   (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
  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

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

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

ClinicalTrials.gov processed this record on June 29, 2017