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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2009 by Cantonal Hospital of St. Gallen.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Cantonal Hospital of St. Gallen

ClinicalTrials.gov Identifier:

NCT00917839

First received: June 9, 2009

Last updated: NA

Last verified: June 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 9, 2009

Last Updated Date

June 9, 2009

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Relapsing-Remitting Multiple Sclerosis

Intervention ^ICMJE

Drug: lamotrigine

100 mg, once daily, 12 months

Study Arms

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

Intervention: Drug: lamotrigine
Placebo Comparator: Placebo
300mg Mannitol with 2% Aerosil

Intervention: Drug: lamotrigine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 50 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Switzerland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00917839

Other Study ID Numbers ^ICMJE

LT.01

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Dr. Norman Putzki, Cantonal Hospital of St. Gallen

Study Sponsor ^ICMJE

Cantonal Hospital of St. Gallen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Cantonal Hospital of St. Gallen

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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