The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
Information source: Cantonal Hospital of St. Gallen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis
Intervention: lamotrigine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Cantonal Hospital of St. Gallen Overall contact: Norman Putzki, MD, Phone: +4171494, Ext: 1663, Email: norman.putzki@kssg.ch
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.
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopySafety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.
Secondary outcome: relapse rateExpanded disability status score Fatigue Severity Score N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Norman Putzki, MD, Phone: +4171494, Ext: 1663, Email: norman.putzki@kssg.ch
Cantonal Hospital St. Gallen, St. Gallen 9007, Switzerland; Recruiting Norman Putzki, MD, Phone: +4171494, Ext: 1663, Email: norman.putzki@kssg.ch Norman Putzki, MD, Principal Investigator Ozgur Yaldizli, MD, Sub-Investigator
Additional Information
Starting date: June 2009
Last updated: June 9, 2009
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