MedPath

Phenytoin

Generic Name
Phenytoin
Brand Names
Dilantin, Phenytek
Drug Type
Small Molecule
Chemical Formula
C15H12N2O2
CAS Number
57-41-0
Unique Ingredient Identifier
6158TKW0C5
Background

Phenytoin is classified as a hydantoin derivative and despite its narrow therapeutic index, it is one of the most commonly used anticonvulsants. Since it's introduction about 80 years ago, phenytoin has not only been established as an effective anti-epileptic, but has also been investigated for several other indications such as bipolar disorder, retina protection, and wound healing.

Clinicians are advised to initiate therapeutic drug monitoring in patients who require phenytoin since even small deviations from the recommended therapeutic range can lead to suboptimal treatment, or adverse effects. Both parenteral and oral formulations of phenytoin are available on the market.

Indication

Phenytoin is indicated to treat grand mal seizures, complex partial seizures, and to prevent and treat seizures during or following neurosurgery. Injectable phenytoin and Fosphenytoin, which is the phosphate ester prodrug formulation of phenytoin, are indicated to treat tonic-clonic status epilepticus, and for the prevention and treatment of seizures occurring during neurosurgery.

Associated Conditions
Complex Partial Seizure Disorder, Generalized Tonic-Clonic Seizures, Grand Mal Status Epilepticus, Jacksonian epilepsy, Partial-Onset Seizures, Petit Mal Epilepsy, Seizure Disorder, Post Traumatic, Seizures, Status; Epilepticus, Tonic-clonic, Temporal Lobe Epilepsy (TLE), Convulsive disorders

A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2023-08-16
Last Posted Date
2024-02-06
Lead Sponsor
Takeda
Target Recruit Count
172
Registration Number
NCT05995249
Locations
🇺🇸

Celerion - Tempe, AZ Site, Tempe, Arizona, United States

A Study to Assess the Effect of Phenytoin on the Drug Levels of Afimetoran and the Effect of Afimetoran on the Drug Levels of Midazolam

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2023-06-13
Last Posted Date
2024-08-07
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
65
Registration Number
NCT05901714
Locations
🇺🇸

Local Institution - 0001, Miami, Florida, United States

The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children

First Posted Date
2023-01-26
Last Posted Date
2023-01-26
Lead Sponsor
Dr Cipto Mangunkusumo General Hospital
Target Recruit Count
100
Registration Number
NCT05697614
Locations
🇮🇩

Cipto Mangunkusumo Hospital, Jakarta Pusat, Jakarta, Indonesia

🇮🇩

Harapan Kita Hospital, Jakarta, Indonesia

🇮🇩

Fatmawati Hospital, Jakarta, Indonesia

Clinical Study Evaluating Safety of Pentoxifylline and Celecoxib in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy

Phase 2
Recruiting
Conditions
Epilepsy
Interventions
First Posted Date
2022-12-05
Last Posted Date
2024-07-18
Lead Sponsor
Mostafa Bahaa
Target Recruit Count
90
Registration Number
NCT05637086
Locations
🇪🇬

Mansoura University, Mansoura, Egypt

A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2021-07-29
Last Posted Date
2021-09-05
Lead Sponsor
Spectrum Pharmaceuticals, Inc
Target Recruit Count
74
Registration Number
NCT04981704
Locations
🇺🇸

Celerion, Phoenix clinical facility, Tempe, Arizona, United States

A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2021-07-09
Last Posted Date
2022-05-13
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
15
Registration Number
NCT04956627
Locations
🇺🇸

Hassman Research Institute, Berlin, New Jersey, United States

DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.

Phase 1
Completed
Conditions
Healthy
NAFLD
Interventions
First Posted Date
2021-04-15
Last Posted Date
2021-07-19
Lead Sponsor
Gannex Pharma Co., Ltd.
Target Recruit Count
24
Registration Number
NCT04845646
Locations
🇺🇸

ICON early Phase Services LLC, San Antonio, Texas, United States

Phenytoin Cream for the Treatment of Neuropathic Pain

Phase 2
Completed
Conditions
Chronic Idiopathic Axonal Polyneuropathy
Interventions
Other: Placebo cream
First Posted Date
2020-12-01
Last Posted Date
2023-06-28
Lead Sponsor
David J. Kopsky
Target Recruit Count
81
Registration Number
NCT04647877
Locations
🇳🇱

University Medical Center Utrecht, Utrecht, Netherlands

Pharmacological Management of Seizures Post Traumatic Brain Injury

Phase 3
Not yet recruiting
Conditions
Traumatic Brain Injury
Post Traumatic Seizures
Interventions
First Posted Date
2020-10-05
Last Posted Date
2020-11-03
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Target Recruit Count
1649
Registration Number
NCT04573803

Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus

Phase 4
Conditions
Management of Pediatric Status Epilepticus
Comparison
the Efficacy of Levetireacetam
Phenytoin
Interventions
First Posted Date
2019-11-25
Last Posted Date
2019-11-25
Lead Sponsor
Tanta University
Target Recruit Count
60
Registration Number
NCT04176887
Locations
🇪🇬

Tanta University, Faculty of Medicine, Tanta, Gharbia, Egypt

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