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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR LAMICTAL ODT

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Clinical Trials for Lamictal Odt

Trial ID Title Status Sponsor Phase Summary
NCT00001482 New Drugs in the Treatment of Mood Disorders Completed National Institute of Mental Health (NIMH) Phase 2 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 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 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.
NCT00067938 Bipolar Study in Adults at Least 18 Years of Age Completed GlaxoSmithKline Phase 4 Bipolar study of tolerability, clinical response and patient satisfaction
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Lamictal Odt

Condition Name

Condition Name for Lamictal Odt
Intervention Trials
Healthy 17
Epilepsy 16
Bipolar Disorder 14
Bipolar Depression 3
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Condition MeSH

Condition MeSH for Lamictal Odt
Intervention Trials
Bipolar Disorder 15
Epilepsy 12
Disease 10
Depression 8
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Clinical Trial Locations for Lamictal Odt

Trials by Country

Trials by Country for Lamictal Odt
Location Trials
United States 258
Germany 19
India 14
Italy 12
Argentina 7
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Trials by US State

Trials by US State for Lamictal Odt
Location Trials
Texas 13
North Carolina 12
New York 12
Minnesota 11
Ohio 10
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Clinical Trial Progress for Lamictal Odt

Clinical Trial Phase

Clinical Trial Phase for Lamictal Odt
Clinical Trial Phase Trials
Phase 4 11
Phase 3 11
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Lamictal Odt
Clinical Trial Phase Trials
Completed 52
Recruiting 5
Not yet recruiting 2
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Clinical Trial Sponsors for Lamictal Odt

Sponsor Name

Sponsor Name for Lamictal Odt
Sponsor Trials
GlaxoSmithKline 24
Dr. Reddy's Laboratories Limited 8
Teva Pharmaceuticals USA 4
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Sponsor Type

Sponsor Type for Lamictal Odt
Sponsor Trials
Industry 45
Other 33
U.S. Fed 2
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