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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Cantonal Hospital of St. Gallen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00917839
First received: June 9, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 9, 2009
June 9, 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 ] [ Designated as safety issue: No ]
  • Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular. [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • relapse rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Expanded disability status score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Fatigue Severity Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Recruiting
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
Both
18 Years to 50 Years
No
Contact: Norman Putzki, MD +4171494 ext 1663 norman.putzki@kssg.ch
Contact: Ozgur Yaldizli, MD +4171494 ext 3587 oezguer.yaldizli@kssg.ch
Switzerland
 
NCT00917839
LT.01
Yes
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