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

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ClinicalTrials.gov Identifier: NCT00917839
Recruitment Status : Unknown
Verified June 2009 by Cantonal Hospital of St. Gallen.
Recruitment status was:  Recruiting
First Posted : June 10, 2009
Last Update Posted : June 10, 2009
Sponsor:
Information provided by:
Cantonal Hospital of St. Gallen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Drug: lamotrigine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : June 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

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Arms and Interventions
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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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Dr. Norman Putzki, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00917839     History of Changes
Other Study ID Numbers: LT.01
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: June 10, 2009
Last Verified: June 2009

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
Interferons
Interferon-beta
Interferon beta-1a
Lamotrigine
Anticonvulsants
 Neuroprotective Agents
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Immunologic Factors
Adjuvants, Immunologic