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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

Tracking Information
First Submitted Date  ICMJE June 20, 2006
First Posted Date  ICMJE June 21, 2006
Last Update Posted Date December 17, 2007
Study Start Date  ICMJE June 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2006)
  • 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
  • Cortical activity determined by fMRI (+/- 3,4 diaminopyridine)
  • Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine)
Change History Complete list of historical versions of study NCT00342381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2006)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation
Official Title  ICMJE Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation
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.
Detailed Description

Only recruiting from:

Department of Neurology, Aarhus University Hospital, Denmark

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis
  • Fatigue
Intervention  ICMJE
  • Drug: 3,4-diaminopyridine
    Single dose 3,4 diaminopyridine
  • Drug: Placebo
    Single dose placebo treatment
    Other Name: n/d
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 20, 2006)
120
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00342381
Other Study ID Numbers  ICMJE 20060003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henning Andersen, Dep of neurology, Aarhus University Hospital
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE The Danish Multiple Sclerosis Society
Investigators  ICMJE
Principal Investigator: Henning Andersen, MD, DMSc Aarhus University Hospital, Aarhus Denmark
Study Chair: Johannes Jacobsen, Professor Aarhus University Hospital, Aarhus, Denmark
PRS Account University of Aarhus
Verification Date December 2007

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