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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Cantonal Hospital of St. Gallen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917839
First Posted: June 10, 2009
Last Update Posted: June 10, 2009
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.
Information provided by:
Cantonal Hospital of St. Gallen
June 9, 2009
June 10, 2009
June 10, 2009
June 2009
December 2010   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
Drug: lamotrigine
100 mg, once daily, 12 months
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
88
December 2011
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00917839
LT.01
Yes
Not Provided
Not Provided
Dr. Norman Putzki, Cantonal Hospital of St. Gallen
Cantonal Hospital of St. Gallen
Not Provided
Not Provided
Cantonal Hospital of St. Gallen
June 2009

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