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Last Updated: March 3, 2021

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CLINICAL TRIALS PROFILE FOR LAMOTRIGINE

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505(b)(2) Clinical Trials for Lamotrigine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00214877 Methylene Blue for Cognitive Dysfunction in Bipolar Disorder Completed Stanley Medical Research Institute Phase 3 2003-11-01 While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.
OTC NCT00214877 Methylene Blue for Cognitive Dysfunction in Bipolar Disorder Completed Nova Scotia Health Authority Phase 3 2003-11-01 While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Lamotrigine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000192 Neurobiology of Opioid Dependence: 1 - 1 Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 1993-01-01 The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.
NCT00000192 Neurobiology of Opioid Dependence: 1 - 1 Withdrawn Yale University Phase 2 1993-01-01 The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.
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.
NCT00006773 Bortezomib in Treating Patients With Recurrent Glioma Terminated National Cancer Institute (NCI) Phase 1 2001-05-01 Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
NCT00007670 Does Gabapentin and Lamotriginel Have Significantly Fewer Side-Effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly. Completed Glaxo Wellcome Phase 3 1998-01-01 New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These patients are especially vulnerable to side effects from medications because of changes caused by the aging process and the fact that these patients often have many common diseases for which they are already receiving medications for so that the likelihood of drug interactions is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of partial onset seizures, the most common seizures in the elderly. These new compounds also have favorable side effect profiles and infrequent drug-drug interactions and, therefore, would be expected to be well-tolerated in the elderly.
NCT00007670 Does Gabapentin and Lamotriginel Have Significantly Fewer Side-Effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly. Completed Parke-Davis Phase 3 1998-01-01 New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These patients are especially vulnerable to side effects from medications because of changes caused by the aging process and the fact that these patients often have many common diseases for which they are already receiving medications for so that the likelihood of drug interactions is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of partial onset seizures, the most common seizures in the elderly. These new compounds also have favorable side effect profiles and infrequent drug-drug interactions and, therefore, would be expected to be well-tolerated in the elderly.
NCT00007670 Does Gabapentin and Lamotriginel Have Significantly Fewer Side-Effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly. Completed VA Office of Research and Development Phase 3 1998-01-01 New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These patients are especially vulnerable to side effects from medications because of changes caused by the aging process and the fact that these patients often have many common diseases for which they are already receiving medications for so that the likelihood of drug interactions is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of partial onset seizures, the most common seizures in the elderly. These new compounds also have favorable side effect profiles and infrequent drug-drug interactions and, therefore, would be expected to be well-tolerated in the elderly.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lamotrigine

Condition Name

Condition Name for Lamotrigine
Intervention Trials
Bipolar Disorder 48
Epilepsy 42
Healthy 20
Bipolar Depression 9
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Condition MeSH

Condition MeSH for Lamotrigine
Intervention Trials
Bipolar Disorder 56
Epilepsy 38
Disease 34
Depression 33
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Clinical Trial Locations for Lamotrigine

Trials by Country

Trials by Country for Lamotrigine
Location Trials
United States 452
Germany 32
China 19
India 18
Italy 16
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Trials by US State

Trials by US State for Lamotrigine
Location Trials
Texas 31
Ohio 26
New York 25
Massachusetts 18
California 18
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Clinical Trial Progress for Lamotrigine

Clinical Trial Phase

Clinical Trial Phase for Lamotrigine
Clinical Trial Phase Trials
Phase 4 49
Phase 3 44
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Lamotrigine
Clinical Trial Phase Trials
Completed 129
Recruiting 18
Terminated 11
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Clinical Trial Sponsors for Lamotrigine

Sponsor Name

Sponsor Name for Lamotrigine
Sponsor Trials
GlaxoSmithKline 56
National Institute of Mental Health (NIMH) 13
Dr. Reddy's Laboratories Limited 8
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Sponsor Type

Sponsor Type for Lamotrigine
Sponsor Trials
Other 145
Industry 105
NIH 21
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