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Last Updated: March 24, 2025

CLINICAL TRIALS PROFILE FOR PHENOBARBITAL SODIUM


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All Clinical Trials for Phenobarbital Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00260143 ↗ Testosterone and Physical Function in HIV+ Men Completed Charles Drew University of Medicine and Science Phase 2 2003-05-01 Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT00260143 ↗ Testosterone and Physical Function in HIV+ Men Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2003-05-01 Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT01730313 ↗ Treatment of Nodding Syndrome - A Randomized Blinded Placebo-Controlled Crossover Trial of Oral Pyridoxine and Conventional Anti-Epileptic Therapy, in Northern Uganda - 2012 Unknown status Ministry of Health, Uganda Phase 2 2013-02-01 Nodding Syndrome (NS) is a novel form of epilepsy seen predominantly among children aged 5-15 years and characterized by head nodding, progressively worsening seizures, and cognitive impairment. To date, the cause of NS remains unclear. A recent assessment by the Uganda Ministry of Health (MOH), World Health Organization (WHO), and US CDC conducted in Kitgum District in northern Uganda documented that the nodding episodes themselves resulted from atonic seizures, and that the children also exhibit multiple different seizure types, both clinically and electrographically. The investigation also found that there was significantly greater sero-positivity for onchocerciasis among children with NS compared with control children, and demonstrated low serum concentrations of vitamin B6 (pyridoxine) among both cases and controls. Vitamin B6 is involved in neurotransmission and has been an effective treatment of seizures for certain rare type of epileptic syndrome. Children with nodding syndrome in Kitgum have been episodically treated with multivitamins, ivermectin, and anti-epileptic medications including phenobarbital, phenytoin, carbamazepine, and valproate, but the possible beneficial or harmful effects of any of these medications for nodding syndrome has not been systematically assessed, and reports from parents and guardians about apparent effectiveness are varied. The investigators propose a randomized blinded four group clinical trial with crossover design to study the effect and response to therapeutic doses of oral pyridoxine (vitamin B6) and treatment with currently used conventional anti-epileptics including phenytoin and sodium valproate, among children with nodding syndrome.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Phenobarbital Sodium

Condition Name

Condition Name for Phenobarbital Sodium
Intervention Trials
Onchocerciasis 1
Dyslipidemias 1
Overuse Headache Medication 1
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Condition MeSH

Condition MeSH for Phenobarbital Sodium
Intervention Trials
Seizures 3
Delirium 2
Syndrome 2
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Clinical Trial Locations for Phenobarbital Sodium

Trials by Country

Trials by Country for Phenobarbital Sodium
Location Trials
United States 4
China 2
Mexico 1
Uganda 1
Congo, The Democratic Republic of the 1
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Trials by US State

Trials by US State for Phenobarbital Sodium
Location Trials
Maine 1
Florida 1
New Jersey 1
California 1
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Clinical Trial Progress for Phenobarbital Sodium

Clinical Trial Phase

Clinical Trial Phase for Phenobarbital Sodium
Clinical Trial Phase Trials
Phase 4 4
Phase 3 3
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Phenobarbital Sodium
Clinical Trial Phase Trials
Unknown status 4
Completed 3
Not yet recruiting 3
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Clinical Trial Sponsors for Phenobarbital Sodium

Sponsor Name

Sponsor Name for Phenobarbital Sodium
Sponsor Trials
Bruyere Research Institute 2
First Affiliated Hospital Xi'an Jiaotong University 1
Kingston Health Sciences Centre 1
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Sponsor Type

Sponsor Type for Phenobarbital Sodium
Sponsor Trials
Other 30
Industry 3
U.S. Fed 1
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Phenobarbital Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Phenobarbital Sodium

Phenobarbital sodium is a central nervous system depressant that has been widely used for decades in the management of seizures, anxiety, and other neurological conditions. It works by enhancing the activity of the neurotransmitter gamma-aminobutyric acid (GABA), which inhibits brain activity, resulting in a calming effect.

Clinical Trials and Regulatory Updates

Recent FDA Approvals and Requirements

In 2022, the FDA approved Sezaby (phenobarbital sodium) for injection for the treatment of neonatal seizures in term and preterm infants. This approval came with specific postmarketing requirements aimed at evaluating the long-term neurodevelopmental safety of the drug.

  • Long-term Neurodevelopmental Studies: The FDA has mandated that the drug manufacturer conduct well-executed controlled clinical trials to evaluate the long-term neurodevelopmental safety of Sezaby. Patients must be followed for a minimum of five years using validated, age-appropriate developmental assessments of motor skills, cognition, language, and behavior[3].

  • QTc Interval Evaluation: The FDA also requires an evaluation of the effects of Sezaby on the QTc interval, designed according to ICH E14 guidance. This study is scheduled to follow a specific timeline, with draft protocol submission by June 2023, final protocol submission by December 2023, study completion by December 2025, and final report submission by December 2026[1].

Study Timelines and Objectives

The clinical trials for Sezaby are meticulously planned to ensure comprehensive evaluation of the drug's safety and efficacy.

  • Draft Protocol Submission: June 2023
  • Final Protocol Submission: December 2023
  • Study Completion: December 2025
  • Final Report Submission: December 2026[1].

These studies are crucial for understanding the long-term effects of phenobarbital sodium, especially in vulnerable populations such as neonates.

Market Analysis

Market Size and Growth

The phenobarbital market is significant and growing. As of 2022, the market size was valued at USD 1.48 billion and is projected to reach USD 2.20 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.6% during the forecast period of 2023-2031[2].

Market Segmentation

The phenobarbital market is segmented based on indication, dosage form, and distribution channel.

  • Indication: The market is primarily segmented into epilepsy and neonatal seizures, with the epilepsy segment being a major contributor[2].
  • Dosage Form: The market includes tablets, injectables, and other formulations. Tablets are expected to grow rapidly due to their ease of administration and handling, particularly for geriatric patients[2].
  • Distribution Channel: The market is divided into hospital pharmacies, retail pharmacies, and online pharmacies[2].

Regional Market

The North American market holds a significant revenue share due to the high incidence of alternative anti-convulsant medication and well-developed healthcare infrastructure. Increasing technological developments and the high efficacy and affordability of phenobarbital are key factors driving market growth in this region[2].

Factors Influencing Market Growth

Drivers

  • High Effectiveness: Phenobarbital's effectiveness in the long-term management of seizures and other neurological conditions is a major driver of market growth[2].
  • Patient Compliance: Good patient compliance and ease of management by healthcare practitioners also boost market expansion[2].
  • Raising Awareness: Increasing awareness among healthcare professionals is expected to propel market growth further[2].

Challenges

  • Addiction and Overdose: High chances of addiction and overdose are significant challenges that could hinder market growth[2].
  • Adverse Effects: Potential adverse effects such as drowsiness and vertigo also hamper market expansion[2].
  • Regulatory Constraints: Strict government regulations will continue to pose challenges to the market in the coming years[2].

Adverse Effects and Safety Concerns

Phenobarbital, while effective, is associated with several adverse effects and safety concerns.

  • Cutaneous Adverse Events: Phenobarbital can cause severe cutaneous adverse events such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). These events are rare but can be fatal, with a reported mortality rate of 26.3% in some studies[4].
  • Neurodevelopmental Safety: The FDA has highlighted the need for long-term neurodevelopmental safety evaluations, particularly in neonates, due to potential neurodevelopmental safety concerns associated with phenobarbital use[3].

Future Scope and Opportunities

Despite the challenges, the phenobarbital market presents several opportunities for growth and development.

  • Emerging Markets: The possibility of expanding into emerging markets offers significant growth opportunities[2].
  • Research and Development: Increasing levels of field research and development can lead to new formulations and improved safety profiles, further driving market growth[2].

Key Takeaways

  • Clinical Trials: Ongoing and planned clinical trials are crucial for assessing the long-term safety and efficacy of phenobarbital sodium, particularly in neonates.
  • Market Growth: The phenobarbital market is projected to grow at a CAGR of 4.6% from 2023 to 2031, driven by its effectiveness and increasing awareness.
  • Regional Dominance: The North American market is expected to hold a significant revenue share due to its well-developed healthcare infrastructure and high incidence of neurological conditions.
  • Challenges and Opportunities: While facing challenges such as addiction, adverse effects, and regulatory constraints, the market also offers opportunities for growth through emerging markets and ongoing research and development.

FAQs

What is the current market size of the phenobarbital market?

The phenobarbital market was valued at USD 1.48 billion in 2022[2].

What is the projected growth rate of the phenobarbital market?

The market is projected to grow at a CAGR of 4.6% from 2023 to 2031[2].

What are the primary indications for phenobarbital?

The primary indications are epilepsy and neonatal seizures[2].

What are the common adverse effects associated with phenobarbital?

Common adverse effects include drowsiness, vertigo, and severe cutaneous adverse events such as SJS and TEN[2][4].

Why is the North American market significant for phenobarbital?

The North American market holds a significant revenue share due to the high incidence of alternative anti-convulsant medication and well-developed healthcare infrastructure[2].

Sources

  1. FDA Approval Letter for Sezaby (Phenobarbital Sodium) for Injection. U.S. Food and Drug Administration.
  2. Phenobarbital Market Latest Trends and Future Scope. InsightAce Analytic.
  3. FDA Prioritizes Neurodevelopmental Safety of Medical Products Used in Neonates. U.S. Food and Drug Administration.
  4. Toxic Epidermal Necrolysis Caused by Phenobarbital: A Case Report. Frontiers in Pharmacology.
  5. Research and Markets: Global and Chinese Phenobarbital Sodium Industry, 2010-2020 Market Research Report. Business Wire.

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