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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00355082 |
This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.
Condition | Intervention | Phase |
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Epilepsy, Partial |
Drug: lamotrigine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures |
Enrollment: | 230 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | November 2008 |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
NOTE: With prior authorization from GlaxoSmithKline (GSK), retrospective data may take the place of up to the first 4 weeks (i.e., first 28 days) of the Baseline Phase for subjects providing reliable documentation of the following (see Appendix 3):
All subjects permitted to use retrospective baseline data must complete a minimum of four weeks (i.e., 28 days) of the prospective Baseline Phase. The retrospective plus the prospective Baseline Phases must equal the 56 consecutive days prior to the start of dosing with study drug.
if female, and of childbearing potential be using an acceptable form of birth control, to include one of the following:
Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject.
Any intrauterine device (IUD) with a documented failure rate of less than 1% per year
Double barrier method consisting of spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm).
NOTE: Women who have had a hysterectomy, tubal ligation, or are post-menopausal are considered to be of non-childbearing potential.
NOTE: A pharmacokinetic interaction has been observed between LTG and estrogen-based oral contraceptives. Therefore, the use of hormonal therapy (e.g., for contraception or hormone replacement therapy) is not allowed.
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | LAM30055 |
Study First Received: | July 19, 2006 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00355082 |
Health Authority: | United States: Food and Drug Administration; Russia: Ministry of Health and Social Development of the Russian Federation |
epilepsy monotherapy lamotrigine Lamictal |
Epilepsies, Partial Calcium, Dietary Epilepsy Seizures |
Lamotrigine Central Nervous System Diseases Brain Diseases |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Nervous System Diseases Calcium Channel Blockers |
Cardiovascular Agents Central Nervous System Agents Anticonvulsants Pharmacologic Actions |