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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-spectroscopy

Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.

Secondary outcome:

relapse rate

Expanded 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

Page last updated: August 23, 2015

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