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The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00917839
Recruitment Status : Unknown
Verified June 2009 by Cantonal Hospital of St. Gallen.
Recruitment status was:  Recruiting
First Posted : June 10, 2009
Last Update Posted : June 10, 2009
Sponsor:
Information provided by:
Cantonal Hospital of St. Gallen

Tracking Information
First Submitted Date  ICMJE June 9, 2009
First Posted Date  ICMJE June 10, 2009
Last Update Posted Date June 10, 2009
Study Start Date  ICMJE June 2009
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2009)
  • N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy [ Time Frame: 12 months ]
  • Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular. [ Time Frame: 6 months, 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2009)
  • relapse rate [ Time Frame: 12 months ]
  • Expanded disability status score [ Time Frame: 12 months ]
  • Fatigue Severity Score [ Time Frame: 12 months ]
  • N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
Official Title  ICMJE Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis.
Brief Summary This study is designed to evaluate the neuroprotective effect of lamotrigine in the combination of interferon beta 1a once weekly intramuscular in patients with relapsing-remitting multiple sclerosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Relapsing-Remitting Multiple Sclerosis
Intervention  ICMJE Drug: lamotrigine
100 mg, once daily, 12 months
Study Arms  ICMJE
  • Experimental: lamotrigine
    7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral
    Intervention: Drug: lamotrigine
  • Placebo Comparator: Placebo
    300mg Mannitol with 2% Aerosil
    Intervention: Drug: lamotrigine
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 9, 2009)		 88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • definitive multiple sclerosis according to Mc Donald criteria
  • clinical isolated syndrome according to Mc Donald criteria
  • Expanded Disability Status Scale Score 0-5
  • Pre-treatment with interferon beta 1a (Avonex) since at least 2 months before inclusion

Exclusion Criteria:

  • relapse within 30 days prior to randomisation
  • steroid pulse therapy within 30 days prior to randomisation
  • pregnancy or poor contraception
  • contraindication for lamotrigine
  • depressive symptoms
  • drugs with possible interaction with lamotrigine according to instruction leaflet
  • other medical relevant conditions but multiple sclerosis
  • clinically relevant laboratory results
  • contraindication for MRI
  • missing informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00917839
Other Study ID Numbers  ICMJE LT.01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Norman Putzki, Cantonal Hospital of St. Gallen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cantonal Hospital of St. Gallen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cantonal Hospital of St. Gallen
Verification Date June 2009

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