Phenytoin

Generic Name: Phenytoin

Brand Names: Dilantin, Phenytek

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₂N_₂O_₂

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

Clinical Trials

Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.

Phase 1

Completed

Conditions: Epilepsy

Interventions: Drug: BIA 2-093
Drug: Phenytoin

First Posted Date: 2014-11-05

Last Posted Date: 2014-12-18

Lead Sponsor: Bial - Portela C S.A.

Target Recruit Count: 32

Registration Number: NCT02283827

Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures

Phase 2

Terminated

Conditions: Nonconvulsive Electrographic Seizures

Interventions: Drug: Brivaracetam intravenous solution
Drug: Phenytoin intravenous solution
Drug: Brivaracetam oral tablets
Drug: Phenytoin oral tablets

First Posted Date: 2014-03-17

Last Posted Date: 2018-07-11

Lead Sponsor: UCB BIOSCIENCES, Inc.

Target Recruit Count: 1

Registration Number: NCT02088957

Locations: 🇺🇸
1, Jackson, Mississippi, United States
🇺🇸
3, Lexington, Kentucky, United States

The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients

Phase 1

Terminated

Conditions: Epilepsy

Interventions: Drug: Placebo
Drug: Eslicarbazepine acetate
Drug: phenytoin

First Posted Date: 2013-06-17

Last Posted Date: 2014-02-27

Lead Sponsor: Bial - Portela C S.A.

Target Recruit Count: 4

Registration Number: NCT01878578

Locations: 🇵🇹
Neurology Department, Hospital of Santa Maria, Lisbon, Portugal

Treatment of Nodding Syndrome - A Randomized Blinded Placebo-Controlled Crossover Trial of Oral Pyridoxine and Conventional Anti-Epileptic Therapy, in Northern Uganda - 2012

Phase 2

Withdrawn

Conditions: Nodding Syndrome

Interventions: Drug: Pyridoxine
Drug: Sodium Valproate
Drug: Phenytoin
Drug: Placebo

First Posted Date: 2012-11-21

Last Posted Date: 2022-05-18

Lead Sponsor: Centers for Disease Control and Prevention

Registration Number: NCT01730313

Locations: 🇺🇬
Kitgum Nodding Syndrome Treatment Center, Kitgum General Hospital, Kitgum, Uganda

Clinical Effect of Phenytoin Mucoadhesive Paste on Wound Healing After Oral Biopsy

Phase 1

Conditions: Wound Healing
Pain

Interventions: Drug: Phenytoin paste
Drug: Placebo

First Posted Date: 2012-09-06

Last Posted Date: 2012-10-02

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Target Recruit Count: 40

Registration Number: NCT01680042

Locations: 🇮🇷
Shahid Beheshti Medical University, Tehran, Iran, Islamic Republic of
🇮🇷
Shaheed Beheshti University, Tehran, Iran, Islamic Republic of

A Study to Investigate the Potential Pharmacokinetic Interactions Between Phenytoin or Carbamazepine and Telaprevir

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Telaprevir
Drug: Phenytoin
Drug: Carbamazepine

First Posted Date: 2012-07-10

Last Posted Date: 2013-10-24

Lead Sponsor: Janssen Infectious Diseases BVBA

Target Recruit Count: 24

Registration Number: NCT01635829

Study on the Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old.

Phase 4

Terminated

Conditions: Pneumococcal Meningitis
Seizures

Interventions: Drug: placebo
Drug: Phenytoin

First Posted Date: 2011-11-23

Last Posted Date: 2023-03-02

Lead Sponsor: M. Carmen Cabellos Minguez

Target Recruit Count: 26

Registration Number: NCT01478035

Locations: 🇪🇸
Hospital Virgen del Rocio, Sevilla, Spain
🇪🇸
Hospital Juan Canalejo, A Coruña, Spain
🇪🇸
Fundacio Institut per la Recerca de l'hospital de la Santa Creu i Sant Pau, Barcelona, Spain

and more 1 locations