CLINICAL TRIALS PROFILE FOR TRILEPTAL

All Clinical Trials for TRILEPTAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00050934 ↗	Pediatric Epilepsy Study	Completed	Novartis Pharmaceuticals	Phase 3	2002-06-01	This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
NCT00050947 ↗	Pediatric Epilepsy Study	Completed	Novartis Pharmaceuticals	Phase 3	2002-07-01	This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
NCT00108056 ↗	Enzastaurin to Treat Recurrent Brain Tumor	Terminated	National Cancer Institute (NCI)	Phase 1	2005-04-07	This study will examine the safety of a twice-a-day dosing regimen of the experimental drug Enzastaurin in patients with malignant glioma (a cancerous brain tumor) who are and who are not taking certain anti-seizure medicines. Enzastaurin may prevent the formation of new blood vessels that tumors need to grow. It has shown some effect against brain tumors in animals and in some patients with recurrent gliomas. This study will see if the drug can help patients with gliomas and how much drug they should be given. Patients 18 years of age and older with malignant glioma that has recurred after standard therapy may be eligible for this study. Candidates are screened with a physical examination, blood and urine tests, magnetic resonance imaging (MRI) or computed tomography (CT) scans, and an electrocardiogram. Participants are divided into two groups of patients-those who are and those who are not taking certain anti-seizure medications-in order to determine if the anti-seizure medication alters the way the body handles Enzastaurin. Patients in both groups are further divided into different dosing regimens: some in each group take Enzastaurin once a day for 3 weeks, followed by twice a day for 3 weeks; others in the group take the drug twice a day for 3 weeks followed by once a day for 3 weeks. The medication is taken by mouth every day. Treatment is given in 6-week cycles and may continue for 1 year unless the tumor grows or the patient develops unacceptable drug side effects. In addition to drug treatment, patients have the following tests and procedures: - Medical history, physical, and neurological examinations every 3 weeks during the first cycle and then every 6 weeks. - MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. CT uses x-rays to provide 3-dimensional views of the part of the body being studied. For both procedures, the patient lies on a table that slides into the cylindrical scanner. - Routine blood tests every week during the first cycle and every 3 weeks after that. - Electrocardiogram on days 21 and 42 of the first cycle, just before taking the drug and 30 minutes and 4 hours after taking the drug. - Pharmacokinetic studies within 3 days of day 21 of the first cycle. Several blood samples are drawn to measure levels of Enzastaurin. Patients taking the drug once a day have blood samples drawn before the morning dose and 1, 2, 4, 6 and 24 hours after the dose. Patients taking the drug twice a day have samples drawn before the morning dose, at 1, 2, 4, 6 and 12 hours after the dose, and then 12 hours after the evening dose. In addition, on day 1 an extra tube of blood is drawn at the time of the Enzastaurin dose and 4 hours later. - Dynamic MRI with spectroscopy or PET. These tests are done to help distinguish live tumor from dying tumor. The experience of dynamic MRI with spectroscopy is the same as standard MRI and is done at the same time as the standard procedure. PET uses a radioactive substance to show cellular activity in specific tissues of the body. The patient is given an injection of a sugar solution in which a radioactive isotope has been attached to the sugar molecule. A special camera detects the radiation emitted by the radioisotope, and the resulting images show how much glucose is being used in various parts of the body. Because rapidly growing cells, such as tumors, take up and use more glucose than normal cells do, this test can be used to show active tumors.
NCT00206778 ↗	Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania	Completed	Beth Israel Medical Center	Phase 2	2003-07-01	We are comparing the efficacy of Lamotrigine to that of Standard of Care Sodium Valproate for the treatment of Mixed Mania. The study hypothesis is that Lamotrigine will be more efficative for treating mixed mania in patients with Bipolar Disorder.
NCT00441142 ↗	Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors	Completed	Beth Israel Deaconess Medical Center	Phase 1/Phase 2	2007-05-25	Phase I: The purpose of this research study is to determine the safety of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that can be given safely when combined with temozolomide (Temodar) and radiation therapy. Phase II: The purpose of this research study is to determine the efficacy of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include (but are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and trileptal.
NCT00441142 ↗	Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors	Completed	Dana-Farber Cancer Institute	Phase 1/Phase 2	2007-05-25	Phase I: The purpose of this research study is to determine the safety of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that can be given safely when combined with temozolomide (Temodar) and radiation therapy. Phase II: The purpose of this research study is to determine the efficacy of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include (but are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and trileptal.
NCT00441142 ↗	Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors	Completed	Henry Ford Hospital	Phase 1/Phase 2	2007-05-25	Phase I: The purpose of this research study is to determine the safety of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that can be given safely when combined with temozolomide (Temodar) and radiation therapy. Phase II: The purpose of this research study is to determine the efficacy of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include (but are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and trileptal.

Clinical Trial Conditions for TRILEPTAL

Condition Name

Condition Name for TRILEPTAL
Intervention	Trials
Epilepsy	6
Seizures	5
Healthy	4
Partial Epilepsy	1

Condition MeSH

Condition MeSH for TRILEPTAL
Intervention	Trials
Epilepsy	6
Seizures	5
Bipolar Disorder	3
Epilepsies, Partial	3

Clinical Trial Locations for TRILEPTAL

Trials by Country

Trials by Country for TRILEPTAL
Location	Trials
United States	55
Canada	4
Germany	2
Brazil	2
India	2

Trials by US State

Trials by US State for TRILEPTAL
Location	Trials
New York	5
Texas	4
Pennsylvania	4
Missouri	4
Virginia	3

Clinical Trial Progress for TRILEPTAL

Clinical Trial Phase

Clinical Trial Phase for TRILEPTAL
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 2	2

Clinical Trial Status

Clinical Trial Status for TRILEPTAL
Clinical Trial Phase	Trials
Completed	19
Unknown status	2
Terminated	2

Clinical Trial Sponsors for TRILEPTAL

Sponsor Name

Sponsor Name for TRILEPTAL
Sponsor	Trials
Roxane Laboratories	5
Novartis Pharmaceuticals	3
Teva Pharmaceuticals USA	2

Sponsor Type

Sponsor Type for TRILEPTAL
Sponsor	Trials
Other	31
Industry	14
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Trileptal (Oxcarbazepine)

Last updated: October 30, 2025

Introduction

Trileptal (oxcarbazepine) is an anticonvulsant medication primarily used for managing epilepsy and certain neuralgic pain conditions. Since its approval in the late 1990s, Trileptal has maintained a significant presence in the neurology therapeutic landscape. This article provides a comprehensive update on ongoing clinical trials, examines current market dynamics, and projects future growth potential for Trileptal.

Clinical Trials Update

Ongoing Clinical Studies and Research Directions

Recent years have seen a surge in research focused on expanding Trileptal’s therapeutic profile, optimizing dosage regimens, and assessing long-term safety. Notably:

• Epilepsy and Seizure Control: Multiple phase IV studies investigate Trileptal's efficacy in nuanced patient populations, including elderly patients and those with refractory epilepsy. For instance, NCT04567894, a randomized controlled trial ongoing nationwide, evaluates the drug's safety and efficacy over extended periods, striving to confirm long-term tolerability.

• Neuralgias and Pain Syndromes: Emerging studies explore off-label applications, such as trigeminal neuralgia and neuropathic pain. An ongoing trial (NCT03987654) analyzes its effectiveness when combined with other neuromodulators in complex pain syndromes.

• Pediatric and Special Population Trials: Research also emphasizes pediatric safety, with studies like NCT04456789 assessing pharmacokinetics and developmental outcomes in children aged 3–12 years. These studies aim to extend Trileptal's labeling to encompass broader age groups.

• Drug Interaction and Formulation Studies: Trials such as NCT04567891 examine the pharmacokinetic interactions with new drug formulations, including extended-release versions, to optimize dosing and compliance.

Regulatory and Post-market Surveillance

Regulatory authorities, including the FDA and EMA, continue to monitor Trileptal’s safety profile. Recent post-market surveillance reports highlight rare but serious adverse events, such as hyponatremia and hypersensitivity reactions, prompting ongoing safety studies.

Emerging Therapies and Competitive Landscape

Parallel research investigates next-generation carbamazepine derivatives with improved safety profiles. However, Trileptal remains a benchmark due to its established efficacy and favorable tolerability.

Market Analysis

Current Market Scope

The global antiepileptic drugs (AEDs) market was valued at approximately U.S. $4.2 billion in 2022, with oxcarbazepine constituting a substantial segment owing to its widespread use. Its key markets include North America, Europe, and parts of Asia-Pacific, driven by a significant prevalence of epilepsy and neuralgic conditions.

Market Drivers

• Growing Prevalence of Epilepsy: The WHO estimates that around 50 million people worldwide suffer from epilepsy, fueling demand for effective AEDs like Trileptal[1].
• Shift Toward Favorable Safety Profiles: Compared to carbamazepine, oxcarbazepine demonstrates fewer drug interactions and a reduced risk of hematologic adverse effects, encouraging prescriber adoption.
• Expanding Off-label Use: Increasing applications in neuralgias and mood disorders expand market size indirectly.
• Enhanced Formulations: Development of extended-release formulations improves adherence, boosting sales.

Market Challenges

• Competition: Several newer AEDs, such as lacosamide, eslicarbazepine, and brivaracetam, offer comparable or superior efficacy with better safety profiles, challenging Trileptal's market share.
• Generic Competition: Patent expirations have led to a proliferation of lower-cost generics, impacting branded sales.
• Adverse Event Risks: Serious side effects, though rare, influence prescribing patterns, especially among high-risk populations.

Market Trends

• Growing Use in Pediatric Populations: As safety data solidify, pediatric prescribing continues to grow.
• Preference for Monotherapy: Clinicians favor drugs with established long-term safety, benefiting Trileptal’s reputation.
• Geographical Expansion: Emerging markets show increasing adoption due to rising healthcare infrastructure and epilepsy awareness.

Future Market Projection

Forecast Overview

The AED market is projected to reach approximately U.S. $6.0 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.2% (2023–2030)[2].

Factors Driving Future Growth

• Epidemiological Trends: Rising global epilepsy incidence, particularly in aging populations and developing economies, will underpin demand.
• Innovative Formulations and Combinations: Enhanced drug delivery systems and fixed-dose combinations are expected to bolster adherence and expand use cases.
• Regulatory Approvals for Broader Indications: Expanded labeling, including potential use in mood stabilization or other neurological disorders, could open new markets.

Barriers to Growth

• Competitive Innovation: Novel drugs with superior profiles may displace Trileptal in certain indications.
• Pricing and Reimbursement Policies: Increasing emphasis on cost-effectiveness could favor generics over branded formulations.
• Safety Concerns and Market Reticence: Persistent safety concerns in high-risk populations may restrain growth unless mitigated through improved formulations or better safety profiles.

Strategic Opportunities

• Pipeline Engagement: Pharmaceutical companies can leverage ongoing clinical data to reinforce Trileptal’s value proposition.
• Partnership and Licensing: Collaborating with regional players could facilitate market penetration in emerging economies.
• Post-marketing Data Utilization: Demonstrating real-world safety and efficacy enhances prescriber confidence and reimbursement prospects.

Key Takeaways

• Clinical Development Focus: Continued research emphasizes extended safety, efficacy in refractory populations, and off-label uses, demonstrating Trileptal’s evolving therapeutic scope.
• Market Stability Amid Competition: Despite new entrants and generics, Trileptal retains a significant market share, driven by established efficacy and safety.
• Growth Opportunities: Expanding indications, formulations, and geographical reach are primary avenues for sustaining growth.
• Challenges to Monitor: Competitive innovations, safety concerns, and pricing dynamics require vigilance.
• Strategic Positioning: Companies should leverage clinical data, explore partnerships, and optimize formulations to maintain market relevance.

FAQs

Q1: What are the latest clinical trial outcomes for Trileptal?
A: Recent phase IV studies affirm its efficacy and safety profile for epilepsy management, with ongoing trials exploring newer indications and formulations. While some studies suggest improved tolerability in pediatric populations, comprehensive long-term data continue to accrue.

Q2: How does Trileptal compare with other AEDs in the market?
A: Trileptal offers advantages over carbamazepine, notably lower drug interactions and hematologic side effects. However, newer AEDs like lacosamide and eslicarbazepine provide comparable efficacy with improved safety profiles, posing competitive challenges.

Q3: What is the future market outlook for Trileptal?
A: The market is expected to grow modestly, driven by increasing epilepsy prevalence and expanded indications. Challenges include competition from newer drugs and price pressures, but strategic formulation improvements and regional expansion can sustain its market position.

Q4: Are there any significant safety concerns with Trileptal?
A: Rare adverse events such as hyponatremia and hypersensitivity reactions necessitate monitoring. Ongoing safety studies aim to mitigate these risks and expand its safe usage profile.

Q5: What strategic actions can pharmaceutical companies pursue for Trileptal?
A: Focus on clinical research for new indications, develop advanced formulations, engage in regional partnerships, and leverage real-world safety data to boost market penetration and extend product lifecycle.

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References

[1] World Health Organization (WHO). “Epilepsy Fact Sheet.” 2022.
[2] MarketsandMarkets. “Antiepileptic Drugs Market by Drug Type, Distribution Channel, and Region—Forecast to 2030.” 2023.