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.
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 9, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 10, 2009
June 1, 2009
1.5 years
June 9, 2009
June 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
12 months
Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.
6 months, 12 months
Secondary Outcomes (4)
relapse rate
12 months
Expanded disability status score
12 months
Fatigue Severity Score
12 months
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
6 months
Study Arms (2)
lamotrigine
EXPERIMENTAL7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral
Placebo
PLACEBO COMPARATOR300mg Mannitol with 2% Aerosil
Interventions
Eligibility Criteria
You may qualify if:
- definitive multiple sclerosis according to Mc Donald criteria
- clinical isolated syndrome according to Mc Donald criteria
- Expanded Disability Status Scale Score 0-5
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 9, 2009
First Posted
June 10, 2009
Study Start
June 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
June 10, 2009
Record last verified: 2009-06