The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Pa
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.
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Lamotrigine
Sodium channel alpha subunit blocker
What it measured
Main measures
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
Immune responseSafety
Other measures (4)
relapse rate
12 months
RelapsesExpanded disability status score
12 months
Disability progressionFatigue Severity Score
12 months
FatigueN-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
6 months
Who could take part
Relapsing MS · 18 to 50
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Jun 2009
Main results due
Dec 2010
Finished
Dec 2011