The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsing-Remitting Multiple Sclerosis | Drug: lamotrigine | Phase 2 |
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 |

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 |
- 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 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Norman Putzki, MD | +4171494 ext 1663 | norman.putzki@kssg.ch | |
Contact: Ozgur Yaldizli, MD | +4171494 ext 3587 | oezguer.yaldizli@kssg.ch |
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 |
Responsible Party: | Dr. Norman Putzki, Cantonal Hospital of St. Gallen |
ClinicalTrials.gov Identifier: | NCT00917839 |
Other Study ID Numbers: |
LT.01 |
First Posted: | June 10, 2009 Key Record Dates |
Last Update Posted: | June 10, 2009 |
Last Verified: | June 2009 |
neuroprotection multiple sclerosis brain atrophy mr-spectroscopy |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Lamotrigine |
Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Sodium Channel Blockers |