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Last Updated: April 19, 2025

CLINICAL TRIALS PROFILE FOR PHENYTOIN SODIUM


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All Clinical Trials for Phenytoin Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00140179 ↗ Valnoctamide in Mania Completed Stanley Medical Research Institute Phase 3 2004-09-01 Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00140179 ↗ Valnoctamide in Mania Completed Beersheva Mental Health Center Phase 3 2004-09-01 Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00257855 ↗ A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis Completed University College London Hospitals Phase 2 2005-11-01 A present there is no safe treatment for reducing rate at which disability worsens in people with secondary progressive multiple sclerosis. Recent research has suggested the possibility that drugs that act by blocking the entry of sodium into nerve cells can protect nerve fibres in the brain and spinal cord. In this trial, the investigators will test whether one such drug, called lamotrigine, can prevent damage to nerve fibres and reduce the rate at which MS worsens. The period of treatment in the trial will run for 2 years.
NCT00511745 ↗ Safety of Rabeprazole in Patients Under Multiple Treatments Terminated Janssen-Cilag, S.A. 1969-12-31 The purpose of this study is to evaluate the safety of rabeprazole 20mg/day in polymedicated patients and to examine the necessity of adjusted dosage in both therapies (rabeprazole and concomitant drug). Proton pump inhibitors (PPI) act in the final step of the gastric secretion. PPI's block ATP-ase H+/K+ in gastric parietals cells. It has been described that inhibition of acid secretion has produced the recovery of the gastroesophageal pathology in a high percentage of the patients resistant to conventional drugs. In this context, the objective of the study is to evaluate the safety of rabeprazole as a concomitant treatment and examine the clinical practice the interaction with drugs whose absorption has gastric pH dependence.
NCT00647621 ↗ Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin® Kapseals® 100 mg Completed Mylan Pharmaceuticals Phase 1 2005-10-01 The objective of this study was to investigate the steady-state bioequivalence of Mylan's extended phenytoin sodium capsules, 100mg (3x100mg), to Pfizer's Dilantin® Kapseals®, 100mg (3x100mg), under both fasting and fed conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Phenytoin Sodium

Condition Name

Condition Name for Phenytoin Sodium
Intervention Trials
Healthy 2
Optic Neuritis 2
Gastroesophageal Reflux 1
Post Traumatic Seizures 1
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Condition MeSH

Condition MeSH for Phenytoin Sodium
Intervention Trials
Epilepsy 2
Multiple Sclerosis 2
Sclerosis 2
Optic Neuritis 2
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Clinical Trial Locations for Phenytoin Sodium

Trials by Country

Trials by Country for Phenytoin Sodium
Location Trials
United States 4
United Kingdom 2
Mexico 1
Israel 1
Malaysia 1
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Trials by US State

Trials by US State for Phenytoin Sodium
Location Trials
New York 1
Georgia 1
California 1
North Dakota 1
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Clinical Trial Progress for Phenytoin Sodium

Clinical Trial Phase

Clinical Trial Phase for Phenytoin Sodium
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Phenytoin Sodium
Clinical Trial Phase Trials
Completed 12
Unknown status 3
Not yet recruiting 2
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Clinical Trial Sponsors for Phenytoin Sodium

Sponsor Name

Sponsor Name for Phenytoin Sodium
Sponsor Trials
University of Kiel 1
Taipei City Hospital 1
Cambridge University Hospitals NHS Foundation Trust 1
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Sponsor Type

Sponsor Type for Phenytoin Sodium
Sponsor Trials
Other 28
Industry 5
NIH 1
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Phenytoin Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Phenytoin sodium, a widely used antiepileptic medication, has been a cornerstone in the management of seizures and epilepsy for decades. This article delves into the recent clinical trials, market analysis, and future projections for this essential drug.

Clinical Trials and Efficacy

Comparative Studies

A notable clinical trial compared the efficacy, tolerability, and impact on quality of life and cognitive functioning of phenytoin versus sodium valproate in patients after craniotomy. This prospective, stratified, randomized, double-blind single-center clinical 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. The study found that both drugs were effective in preventing seizures, but there were differences in tolerability and cognitive impact. Phenytoin was associated with fewer cognitive side effects compared to sodium valproate[1].

Pediatric Use

Clinical trials have also focused on the safety and efficacy of phenytoin and its prodrug, fosphenytoin, in pediatric patients. Studies have shown that fosphenytoin is generally safe and well-tolerated in pediatric patients from birth through 16 years of age. The use of modeling and simulation approaches has helped in determining appropriate dosing recommendations for fosphenytoin in pediatric subjects across various age groups[3].

Mechanism of Action and Pharmacology

Phenytoin acts as a non-specific sodium channel blocker, targeting almost all voltage-gated sodium channel subtypes. This mechanism prevents the positive feedback loop that results in neuronal propagation of high-frequency action potentials, thereby preventing seizures. It is highly protein-bound, with only the unbound fraction exerting a pharmacological effect. This necessitates therapeutic drug monitoring to guide dosing due to its narrow therapeutic index[4].

Market Analysis

Global Market Size and Growth

The global phenytoin sodium market was valued at USD 86,984.2 million in 2024 and is projected to expand at a compound annual growth rate (CAGR) of 9.20% from 2024 to 2031, reaching USD 161,064.1 million by 2031. This growth is driven by the increasing prevalence of epilepsy worldwide, particularly in developing countries, and rising awareness about the effectiveness of phenytoin sodium in managing neurological conditions[2].

Regional Market Breakdown

  • North America: Held more than 40% of the global revenue with a market size of USD 34,793.68 million in 2024, expected to grow at a CAGR of 7.4% from 2024 to 2031.
  • Europe: Accounted for more than 30% of the global revenue with a market size of USD 26,095.26 million in 2024, expected to grow at a CAGR of 7.7% from 2024 to 2031.
  • Asia Pacific: Held around 23% of the global revenue with a market size of USD 20,006.37 million in 2024, expected to grow at a CAGR of 11.2% from 2024 to 2031.
  • Latin America: Represented more than 5% of the global revenue with a market size of USD 4,349.21 million in 2024, expected to grow at a CAGR of 8.6% from 2024 to 2031.
  • Middle East and Africa: Held around 2% of the global revenue with a market size of USD 1,739.68 million in 2024, expected to grow at a CAGR of 8.9% from 2024 to 2031[2].

Market Drivers and Restraints

Key drivers include the increasing incidence of epilepsy, technological advancements in drug formulations, and rising awareness about the drug's effectiveness. However, challenges such as generic competition and stringent regulatory requirements for drug approval remain significant restraints[2].

Trends in the Market

The market is seeing a growing preference for generic formulations due to cost-effectiveness, regulatory approvals for new indications beyond epilepsy, and ongoing research to improve drug efficacy and safety profiles[2].

Future Projections

Expanding Healthcare Access

The phenytoin sodium market is poised for steady growth with ongoing research in neurology and expanding healthcare access in emerging economies. As healthcare infrastructure improves in developing countries, the demand for effective antiepileptic medications like phenytoin sodium is expected to increase[2].

Technological Advancements

Advancements in drug formulations and delivery methods are expected to enhance market growth. New formulations and delivery systems could improve the efficacy and safety profile of phenytoin sodium, making it more appealing to both patients and healthcare providers[2].

Regulatory Environment

Regulatory approvals for new indications beyond epilepsy will continue to drive market growth. However, the stringent regulatory environment will remain a challenge, necessitating continuous innovation and compliance from manufacturers[2].

Key Takeaways

  • Phenytoin sodium remains a crucial medication in the management of seizures and epilepsy.
  • Clinical trials have demonstrated its efficacy and tolerability, especially in comparison to other antiepileptic drugs.
  • The global market is projected to grow significantly, driven by increasing prevalence of epilepsy and technological advancements.
  • Regional markets show varied growth rates, with Asia Pacific expected to grow the fastest.
  • Market trends include a preference for generic formulations and ongoing research to improve drug efficacy.

FAQs

What is the primary use of phenytoin sodium?

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

How does phenytoin sodium work?

Phenytoin sodium acts as a non-specific sodium channel blocker, preventing the positive feedback loop that results in neuronal propagation of high-frequency action potentials, thereby preventing seizures[4].

What is the global market size of phenytoin sodium in 2024?

The global phenytoin sodium market size was estimated at USD 86,984.2 million in 2024[2].

What are the key drivers of the phenytoin sodium market?

Key drivers include the increasing prevalence of epilepsy, technological advancements in drug formulations, and rising awareness about the drug's effectiveness[2].

What are the challenges facing the phenytoin sodium market?

Challenges include generic competition and stringent regulatory requirements for drug approval[2].

Sources

  1. Comparative double blind clinical trial of phenytoin and sodium valproate - PubMed
  2. Global Phenytoin Sodium Market Report 2024 - Cognitive Market Research
  3. NDA 20450 Suppl 003, Clinical Review - FDA
  4. Phenytoin: Uses, Interactions, Mechanism of Action - DrugBank Online
  5. Phenytoin Sodium Market Size, Share, Trend and Forecast to 2025 - Prof Research

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