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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00917839
• Other study ID #: LT.01
• Status: Recruiting
• Phase: Phase 2
• First received: June 9, 2009
• Last updated: June 9, 2009
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2009
• Source: Cantonal Hospital of St. Gallen
• Contact: Norman Putzki, MD
• Phone: +4171494
• Email: norman.putzki[@]kssg.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• lamotrigine
100 mg, once daily, 12 months

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy		12 months	No
Primary	Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.		6 months, 12 months	Yes
Secondary	relapse rate		12 months	No
Secondary	Expanded disability status score		12 months	No
Secondary	Fatigue Severity Score		12 months	No
Secondary	N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy		6 months	No