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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR GABAPENTIN

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Clinical Trials for Gabapentin

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.
NCT00006773 Bortezomib in Treating Patients With Recurrent Glioma Terminated National Cancer Institute (NCI) Phase 1 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 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 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 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.
NCT00011297 Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 This study will evaluate a safe and useful medication for outpatient detoxification that is as effective as benzodiazepines in the short-term, and more effective in the protracted withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine, lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.
NCT00015106 Resperine, Gabapentin, or Lamotrigine for the Treatment of Cocaine Dependence: 2 - 7 Completed National Institute on Drug Abuse (NIDA) Phase 2 The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the treatment of cocaine dependence using reserpine, gabapentin, or lamotrigine vs. an unmatched placebo control.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Gabapentin

Condition Name

Condition Name for Gabapentin
Intervention Trials
Pain 28
Postoperative Pain 18
Healthy 16
Pain, Postoperative 15
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Condition MeSH

Condition MeSH for Gabapentin
Intervention Trials
Pain, Postoperative 53
Neuralgia 44
Restless Legs Syndrome 23
Syndrome 20
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Clinical Trial Locations for Gabapentin

Trials by Country

Trials by Country for Gabapentin
Location Trials
United States 611
Japan 43
Canada 34
Brazil 16
Germany 12
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Trials by US State

Trials by US State for Gabapentin
Location Trials
California 44
New York 35
Texas 30
Florida 29
North Carolina 26
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Clinical Trial Progress for Gabapentin

Clinical Trial Phase

Clinical Trial Phase for Gabapentin
Clinical Trial Phase Trials
Phase 4 103
Phase 3 70
Phase 2/Phase 3 17
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Clinical Trial Status

Clinical Trial Status for Gabapentin
Clinical Trial Phase Trials
Completed 185
Recruiting 68
Not yet recruiting 37
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Clinical Trial Sponsors for Gabapentin

Sponsor Name

Sponsor Name for Gabapentin
Sponsor Trials
Pfizer 35
XenoPort, Inc. 17
National Cancer Institute (NCI) 12
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Sponsor Type

Sponsor Type for Gabapentin
Sponsor Trials
Other 318
Industry 111
NIH 48
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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Farmers Insurance
Citi
Covington
Express Scripts
Julphar
Mallinckrodt
Healthtrust

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