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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR PHENYTOIN

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505(b)(2) Clinical Trials for Phenytoin

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 NCT00011063 Effect of Ginkgo Biloba on Phenytoin Elimination Completed National Institutes of Health Clinical Center (CC) Phase 1 2001-02-01 This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between ginkgo biloba and other medications. This study will look at how ginkgo biloba affects the elimination of phenytoin-a medication used to treat patients with seizures. Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age must use a reliable form of birth control other than oral contraceptives ("the pill"). For at least 2 weeks before the study and throughout its duration, study participants may not have any of the following: 1) medications that can affect platelet function (e.g., aspirin, Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit juice; and 4) all medications except those given by study personnel. On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on this first study day is collected through a catheter (small plastic tube) placed in a vein to avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and then returns to the clinic for the remaining blood draws, which are taken by direct needlestick. When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and 8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure. Subjects continue taking ginkgo during this second phenytoin study.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Phenytoin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000285 Effects of Phenytoin on Cocaine Use in Humans - 2 Completed University of Minnesota - Clinical and Translational Science Institute Phase 1 1996-05-01 The purpose of this study is to determine the effects of phenytoin on the self-administration of smoked cocaine.
NCT00000285 Effects of Phenytoin on Cocaine Use in Humans - 2 Completed National Institute on Drug Abuse (NIDA) Phase 1 1996-05-01 The purpose of this study is to determine the effects of phenytoin on the self-administration of smoked cocaine.
NCT00004403 Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis Completed Johns Hopkins University N/A 2000-05-01 OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the severity and duration of epilepsy due to neurocysticercosis. II. Determine the effect of a short course of albendazole on Taenia solium cysts present in the brain. III. Determine the natural regression of cerebral T. solium cysts in patients given placebo and their response to treatment at the end of the study.
NCT00004817 Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures Completed Harborview Injury Prevention and Research Center Phase 3 1991-02-01 OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will reduce the risk of developing seizures as a result of the head injury. II. Determine the safety of valproate, the appropriate dose, and the effect valproate may have on the recovery of the brain's ability to compute numbers, solve problems, remember information, and control the movement of limbs after head injury.
NCT00004817 Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 3 1991-02-01 OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will reduce the risk of developing seizures as a result of the head injury. II. Determine the safety of valproate, the appropriate dose, and the effect valproate may have on the recovery of the brain's ability to compute numbers, solve problems, remember information, and control the movement of limbs after head injury.
NCT00006025 Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma Completed National Cancer Institute (NCI) Phase 1/Phase 2 2000-11-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
NCT00006025 Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma Completed North American Brain Tumor Consortium Phase 1/Phase 2 2000-11-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Phenytoin

Condition Name

Condition Name for Phenytoin
Intervention Trials
Epilepsy 21
Healthy 8
Seizures 7
Epilepsies, Partial 5
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Condition MeSH

Condition MeSH for Phenytoin
Intervention Trials
Epilepsy 16
Seizures 13
Epilepsies, Partial 6
Glioma 4
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Clinical Trial Locations for Phenytoin

Trials by Country

Trials by Country for Phenytoin
Location Trials
United States 102
United Kingdom 6
Israel 6
Spain 4
Netherlands 3
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Trials by US State

Trials by US State for Phenytoin
Location Trials
Texas 10
Pennsylvania 9
Maryland 9
New York 8
Ohio 7
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Clinical Trial Progress for Phenytoin

Clinical Trial Phase

Clinical Trial Phase for Phenytoin
Clinical Trial Phase Trials
Phase 4 20
Phase 3 15
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Phenytoin
Clinical Trial Phase Trials
Completed 50
Recruiting 18
Unknown status 12
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Clinical Trial Sponsors for Phenytoin

Sponsor Name

Sponsor Name for Phenytoin
Sponsor Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 6
Emory University 5
National Cancer Institute (NCI) 5
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Sponsor Type

Sponsor Type for Phenytoin
Sponsor Trials
Other 140
Industry 38
NIH 12
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