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
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Sponsor:
Cantonal Hospital of St. Gallen
Information provided by:
Cantonal Hospital of St. Gallen
Tracking Information | |||
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First Submitted Date ICMJE | June 9, 2009 | ||
First Posted Date ICMJE | June 10, 2009 | ||
Last Update Posted Date | June 10, 2009 | ||
Study Start Date ICMJE | June 2009 | ||
Estimated Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | 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 ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Relapsing-Remitting Multiple Sclerosis | ||
Intervention ICMJE | Drug: lamotrigine
100 mg, once daily, 12 months
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Estimated Enrollment ICMJE |
88 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date ICMJE | December 2011 | ||
Estimated Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
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 ICMJE | Not Provided | ||
Current Responsible Party | Dr. Norman Putzki, Cantonal Hospital of St. Gallen | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Cantonal Hospital of St. Gallen | ||
Original Study Sponsor ICMJE | Same as current | ||
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 |