CLINICAL TRIALS PROFILE FOR LAMICTAL ODT
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All Clinical Trials for LAMICTAL ODT
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00001482 ↗ | New Drugs in the Treatment of Mood Disorders | Completed | National Institute of Mental Health (NIMH) | Phase 2 | 1995-05-01 | This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal) Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so that we examine possible clinical and biological factors predictors of response. The drugs will be given in a randomized order for six weeks each and you will not know when you are on a given one. There will be a 2-4 week "washout" period between treatments. If you respond well to one of these treatments, a longer open continuation period will be offered at the end of this study. This would involve one or both drugs in combination. A variety of rating scales and brain imaging procedures will also be offered before and during each drug evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine, however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually mild, and resolve with continued time on the drug or a decrease in dosage. |
| NCT00043875 ↗ | Pediatric Epilepsy Trial in Subjects 1-24 Months | Completed | GlaxoSmithKline | Phase 2 | 2000-05-01 | This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older. |
| NCT00044278 ↗ | Pediatric Epilepsy Study in Subjects 1-24 Months | Completed | GlaxoSmithKline | Phase 2 | 2000-09-01 | This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications. |
| NCT00056277 ↗ | Bipolar Disorder Study for Men and Women | Completed | GlaxoSmithKline | Phase 3 | 2003-02-27 | A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder |
| NCT00063362 ↗ | Combination Therapy for the Treatment of Bipolar Disorders | Terminated | National Institute of Mental Health (NIMH) | Phase 3 | 2002-02-01 | This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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