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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
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
  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 2

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:

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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon-beta
Interferons
Interferon beta-1a
Lamotrigine
Anticonvulsants
 Neuroprotective Agents
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 26, 2016