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

The recruitment status of this study is unknown because the information has not been verified recently.

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

First Received on June 9, 2009. No Changes Posted

Sponsor:	Cantonal Hospital of St. Gallen
Information provided by:	Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:	NCT00917839

Purpose

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.

Condition	Intervention	Phase
Relapsing-Remitting Multiple Sclerosis	Drug: lamotrigine	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon-beta Lamotrigine Interferon beta 1a Interferons

U.S. FDA Resources

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:

N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular. [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

relapse rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Expanded disability status score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Fatigue Severity Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	88
Study Start Date:	June 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917839

Contacts

Contact: Norman Putzki, MD	+4171494 ext 1663	norman.putzki@kssg.ch
Contact: Ozgur Yaldizli, MD	+4171494 ext 3587	oezguer.yaldizli@kssg.ch

Locations

Switzerland
Cantonal Hospital St. Gallen	Recruiting
St. Gallen, Switzerland, 9007
Contact: Norman Putzki, MD +4171494 ext 1663 norman.putzki@kssg.ch
Principal Investigator: Norman Putzki, MD
Sub-Investigator: Ozgur Yaldizli, MD

Sponsors and Collaborators

Cantonal Hospital of St. Gallen

More Information

No publications provided

Responsible Party:	Dr. Norman Putzki, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:	NCT00917839 History of Changes
Other Study ID Numbers:	LT.01
Study First Received:	June 9, 2009
Last Updated:	June 9, 2009
Health Authority:	Switzerland: Swissmedic

Keywords provided by Cantonal Hospital of St. Gallen:

neuroprotection
multiple sclerosis
brain atrophy
mr-spectroscopy

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta 1a
Lamotrigine
Neuroprotective Agents

Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anticonvulsants
Central Nervous System Agents
Adjuvants, Immunologic
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012