CLINICAL TRIALS PROFILE FOR PHENYTOIN

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.

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	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	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	2001-01-05	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.

Clinical Trial Conditions for phenytoin

Condition Name

Condition Name for phenytoin
Intervention	Trials
Epilepsy	23
Healthy	10
Seizures	7
Epilepsies, Partial	5

Condition MeSH

Condition MeSH for phenytoin
Intervention	Trials
Epilepsy	25
Seizures	14
Status Epilepticus	9
Epilepsies, Partial	6

Clinical Trial Locations for phenytoin

Trials by Country

Trials by Country for phenytoin
Location	Trials
United States	129
Spain	6
Israel	6
United Kingdom	4
India	4

Trials by US State

Trials by US State for phenytoin
Location	Trials
New York	11
Texas	10
Maryland	10
California	8
Ohio	7

Clinical Trial Progress for phenytoin

Clinical Trial Phase

Clinical Trial Phase for phenytoin
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	16
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for phenytoin
Clinical Trial Phase	Trials
Completed	67
Unknown status	17
Terminated	17

Clinical Trial Sponsors for phenytoin

Sponsor Name

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

Sponsor Type

Sponsor Type for phenytoin
Sponsor	Trials
Other	182
Industry	45
NIH	14

Phenytoin Market Analysis and Financial Projection

Phenytoin: Clinical Trials, Market Analysis, and Projections

Introduction to Phenytoin

Phenytoin, a well-established antiepileptic medication, has been a cornerstone in the treatment of various seizure disorders for decades. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Comparative Studies

A notable clinical trial compared the efficacy, tolerability, and impact on cognitive functioning of phenytoin versus sodium valproate as anticonvulsant prophylaxis after craniotomy. This prospective, randomized, double-blind trial involved 100 patients, with 50 receiving 300 mg of phenytoin per day and the other 50 receiving 1500 mg of sodium valproate per day for one year post-surgery. The study found that both drugs were effective, but there were differences in tolerability and cognitive impact[1].

Indications and Mechanism of Action

Phenytoin is indicated for treating grand mal seizures, complex partial seizures, and for preventing and treating seizures during or following neurosurgery. It acts by inhibiting the positive feedback loop that results in neuronal propagation of high-frequency action potentials, primarily through its action on voltage-gated sodium channels[4].

Market Analysis

Global Market Growth

The global phenytoin market is expected to experience significant growth from 2020 to 2025, driven by an impressive Compound Annual Growth Rate (CAGR). This growth is attributed to the increasing prevalence of epilepsy and the need for effective antiepileptic medications. The market is segmented by type (pill, injection, and others), application (epilepsy treatment, nerve analgesia, and others), and region[2].

Regional Market Insights

• North America: This region is expected to grow at the highest CAGR due to the presence of major players and a well-developed healthcare infrastructure.
• East Asia: China is a prominent market in this region, driven by the widespread adoption of phenytoin testing and higher incidence of epilepsy.
• Latin America: This region is anticipated to show sluggish growth due to a low adoption rate for phenytoin toxicity testing.
• South Asia: Higher renal failure rates in epileptic patients are expected to drive growth in this region.
• Middle East and Africa: Growth is stagnant due to slow improvements in healthcare standards[3].

Market Segments

The phenytoin market is segmented based on type and application. The tablets segment accounted for a noticeable share of the global market in 2023 and is projected to experience significant growth. The seizures segment is expected to expand at a significant CAGR throughout the forecast period[5].

Market Projections

Revenue and Volume Growth

The global phenytoin market is forecasted to grow significantly from 2024 to 2031. The market size is estimated based on historical data from 2019 to 2023, with projections extending to 2031. The report includes detailed insights into market trends, drivers, opportunities, and restraints[5].

Impact of COVID-19

The COVID-19 pandemic has had various impacts on the phenytoin market, including potential opportunities and challenges. Market growth forecasts are provided under different scenarios (optimistic, pessimistic, very optimistic, most likely) to account for the pandemic's effects[2].

Phenytoin Testing Market

Growth Drivers

The phenytoin testing market is driven by the increasing incidence of phenytoin toxicity, the growing burden of epilepsy, and post-surgical complications causing seizures. Advanced ELISA tests and specific reagents are anticipated to drive this market's growth. The high prescription rate for phenytoin, particularly in the US, also fuels the demand for phenytoin testing[3].

Regional Overview

North America is the prominent regional market for phenytoin testing due to high prescription rates and a wide range of pathological tests available. China is a significant market in East Asia, while Latin America and the Middle East & Africa are expected to show slower growth rates[3].

Key Participants and Competitive Landscape

The phenytoin market includes key players such as Actavis Mid Atlantic LLC, Wockhardt Ltd, and others. These companies are focusing on strategy building and expanding their product portfolios to strengthen their market positions[5].

Technological and Regulatory Trends

Advanced Testing Methods

The development of phenytoin-specific reagents and advanced ELISA tests is expected to enhance the accuracy and efficiency of phenytoin testing. Point-of-care testing and rapid turnaround times for results are also major factors driving the growth of the phenytoin testing market[3].

Regulatory and Awareness Initiatives

Initiatives by non-governmental organizations to raise awareness about drug adherence and drug abuse testing are anticipated to propel the growth of the phenytoin testing market. Regulatory frameworks and guidelines for therapeutic drug monitoring also play a crucial role in shaping the market[3].

Conclusion

Phenytoin remains a vital medication in the management of seizure disorders, with ongoing clinical trials and market analyses highlighting its efficacy and market potential. The global phenytoin market is poised for significant growth, driven by increasing demand, technological advancements, and regulatory support.

Key Takeaways

• Efficacy and Tolerability: Phenytoin is effective in preventing and treating seizures, with varying tolerability compared to other antiepileptic drugs.
• Market Growth: The global phenytoin market is expected to grow significantly from 2020 to 2025, driven by a high CAGR.
• Regional Insights: North America and East Asia are key regions driving market growth, while Latin America and the Middle East & Africa show slower growth.
• Technological Advancements: Advanced testing methods and point-of-care testing are driving the growth of the phenytoin testing market.
• Regulatory and Awareness Initiatives: Initiatives to raise awareness about drug adherence and testing are expected to support market growth.

FAQs

What are the primary indications for phenytoin?

Phenytoin is indicated to treat grand mal seizures, complex partial seizures, and to prevent and treat seizures during or following neurosurgery[4].

How does phenytoin work?

Phenytoin works by inhibiting the positive feedback loop that results in neuronal propagation of high-frequency action potentials, primarily through its action on voltage-gated sodium channels[4].

What are the key drivers of the phenytoin market growth?

The key drivers include the increasing prevalence of epilepsy, technological advancements in testing methods, and regulatory support for therapeutic drug monitoring[2][3].

Which regions are expected to show the highest growth in the phenytoin market?

North America and East Asia are expected to show the highest growth rates due to high prescription rates and advanced healthcare infrastructure[2][3].

What are the challenges faced by the phenytoin market in certain regions?

Latin America and the Middle East & Africa face challenges such as low adoption rates for phenytoin toxicity testing and slow improvements in healthcare standards[3].

Sources

1. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy: efficacy, tolerability, and cognitive functioning. PubMed.
2. Phenytoin Sodium Market Is Likely to Experience a Tremendous Growth during 2020-2025. OpenPR.
3. Phenytoin Testing Market Insights with Upcoming Trends, Segmentation, Opportunities, and Forecast to 2025. PharmiWeb.
4. Phenytoin: Uses, Interactions, Mechanism of Action. DrugBank Online.
5. Phenytoin Market Report 2024 (Global Edition). Cognitive Market Research.