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

June 9, 2009 updated by: Cantonal Hospital of St. Gallen

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Recruiting
        • Cantonal Hospital St. Gallen
        • Contact:
        • Principal Investigator:
          • Norman Putzki, MD
        • Sub-Investigator:
          • Ozgur Yaldizli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lamotrigine
7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral
Drug: lamotrigine
100 mg, once daily, 12 months
Placebo Comparator: Placebo
300mg Mannitol with 2% Aerosil
Drug: lamotrigine
100 mg, once daily, 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
Time Frame: 12 months
12 months
Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.
Time Frame: 6 months, 12 months
6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
relapse rate
Time Frame: 12 months
12 months
Expanded disability status score
Time Frame: 12 months
12 months
Fatigue Severity Score
Time Frame: 12 months
12 months
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Estimate)

June 10, 2009

Last Update Submitted That Met QC Criteria

June 9, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT.01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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