Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 20, 2006
December 12, 2007
June 2006
Not Provided
  • 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 ]
  • Subjective fatigue (FSS)
  • Maximal voluntary isometric contraction, central activation before and after exercise
  • Digit Symbol-Coding scores
  • Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters)
  • Cortical atrophy
  • Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine)
  • Cortical activity determined by fMRI (+/- 3,4 diaminopyridine)
Complete list of historical versions of study NCT00342381 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Subjective fatigue (MFI-20, danish version)
  • Rapid voluntary twitches
  • 6 minute walk test
  • WAIS/WMS tests
  • WHO-5 Questionnaire
  • Major Depression Inventory
  • Lesion load
  • Whole brain atrophy
  • Subjective fatigue (VAS)
Not Provided
Not Provided
 
Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation
Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation

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.

Only recruiting from:

Department of Neurology, Aarhus University Hospital, Denmark

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Multiple Sclerosis
  • Fatigue
  • Drug: 3,4-diaminopyridine
    Single dose 3,4 diaminopyridine
  • Drug: Placebo
    Single dose placebo treatment
    Other Name: n/d
  • Active Comparator: 3.4 diaminopyridine
    Single dose 3,4 diaminopyridine
    Intervention: Drug: 3,4-diaminopyridine
  • Placebo Comparator: Placebo
    Two tablets identical to active treatment
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2007
Not Provided

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00342381
20060003
Yes
Henning Andersen, Dep of neurology, Aarhus University Hospital
University of Aarhus
The Danish Multiple Sclerosis Society
Principal Investigator: Henning Andersen, MD, DMSc Aarhus University Hospital, Aarhus Denmark
Study Chair: Johannes Jacobsen, Professor Aarhus University Hospital, Aarhus, Denmark
University of Aarhus
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP