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Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR LAMICTAL


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All Clinical Trials for LAMICTAL

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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for LAMICTAL

Condition Name

Condition Name for LAMICTAL
Intervention Trials
Bipolar Disorder 24
Epilepsy 21
Healthy 17
Bipolar Depression 6
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Condition MeSH

Condition MeSH for LAMICTAL
Intervention Trials
Bipolar Disorder 27
Epilepsy 24
Disease 17
Depression 17
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Clinical Trial Locations for LAMICTAL

Trials by Country

Trials by Country for LAMICTAL
Location Trials
United States 336
Germany 27
India 14
Italy 12
Korea, Republic of 8
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Trials by US State

Trials by US State for LAMICTAL
Location Trials
New York 20
Texas 17
Ohio 16
North Carolina 14
California 14
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Clinical Trial Progress for LAMICTAL

Clinical Trial Phase

Clinical Trial Phase for LAMICTAL
Clinical Trial Phase Trials
Phase 4 19
Phase 3 20
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for LAMICTAL
Clinical Trial Phase Trials
Completed 79
Terminated 7
Unknown status 4
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Clinical Trial Sponsors for LAMICTAL

Sponsor Name

Sponsor Name for LAMICTAL
Sponsor Trials
GlaxoSmithKline 34
Dr. Reddy's Laboratories Limited 8
National Institute of Mental Health (NIMH) 7
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Sponsor Type

Sponsor Type for LAMICTAL
Sponsor Trials
Other 76
Industry 60
NIH 10
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