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.

Clinical Trial Conditions for trileptal

Condition Name

Condition Name for trileptal
Intervention	Trials
Epilepsy	6
Seizures	5
Healthy	4
Polyneuropathy	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
Mexico	2
Germany	2
Brazil	2

Trials by US State

Trials by US State for trileptal
Location	Trials
New York	5
Texas	4
Pennsylvania	4
Missouri	4
Massachusetts	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

Trileptal Market Analysis and Financial Projection

Trileptal (Oxcarbazepine): Clinical Trials, Market Analysis, and Projections

Introduction to Trileptal

Trileptal, also known as oxcarbazepine, is an antiepileptic medication used in the treatment of partial-onset seizures in both adults and pediatric patients. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Usage

Current Indications and Usage

Trileptal is indicated for monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and for similar uses in pediatric patients aged 2-16 years[1].

Dosage and Administration

The dosage of Trileptal varies depending on the patient's age and the specific treatment regimen. For adults, the initial dose is typically 600 mg/day, given twice a day, with possible increments to a maximum recommended daily dose of 1200 mg/day. For pediatric patients, the dose is weight-based, starting at 8-10 mg/kg/day and adjusting as necessary[1].

Safety and Side Effects

One of the notable side effects of Trileptal is the risk of hyponatremia (low sodium levels), which can occur in approximately 2.5% of patients. This condition is usually asymptomatic but can be severe in some cases. Patients with a history of hyponatremia or those at risk should be closely monitored[1].

Genetic Considerations

Testing for the HLA-B*1502 allele is recommended in patients from genetically at-risk populations before initiating Trileptal, as this allele is associated with an increased risk of severe skin reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)[1].

Ongoing and Future Clinical Trials

While there are no specific ongoing clinical trials for Trileptal itself mentioned in recent sources, it is important to note that the drug has been well-established in its current indications. However, the broader landscape of epilepsy treatment is evolving, with new drugs and formulations being tested.

For example, Marinus Pharmaceuticals is conducting trials on ganaxolone, another antiepileptic drug, which may provide insights into future treatment options for epilepsy. The Phase 3 RAISE trial evaluating intravenous ganaxolone for refractory status epilepticus is ongoing, with topline results expected in the summer of 2024[3].

Market Analysis

Current Market Position

Trileptal, as an established antiepileptic drug, holds a significant position in the epilepsy treatment market. However, the market dynamics are influenced by various factors including the introduction of new drugs, generic competition, and changes in treatment algorithms.

Competition and Market Trends

The epilepsy market is seeing a shift towards newer therapies, including those targeting specific mechanisms such as ion channels and neurotransmitter modulation. While Trileptal remains a viable option, its market share may be affected by the introduction of newer, potentially more effective or safer alternatives.

Generic Competition

Generic versions of Trileptal have been available since the patent expiration of the original formulation. This has led to increased competition and potentially reduced market share for the branded version. However, the specific impact on Trileptal's market position would depend on factors such as pricing strategies and patient preference.

Projections and Future Outlook

Market Growth and Trends

The overall epilepsy market is expected to grow, driven by an increasing prevalence of epilepsy and the development of new therapeutic options. However, Trileptal's specific growth trajectory may be influenced by the uptake of newer drugs and the generic competition.

Impact of New Therapies

Newer therapies, such as those developed by Marinus Pharmaceuticals, could potentially alter the treatment landscape for epilepsy. If these new drugs demonstrate superior efficacy or safety profiles, they may capture market share from established drugs like Trileptal.

Regulatory and Economic Factors

Regulatory changes and economic factors, such as reimbursement policies and healthcare budgets, can also impact the market position of Trileptal. For instance, the increasing use of biosimilars and generics in other therapeutic areas, as seen in the NSCLC market, could set a precedent for similar trends in the epilepsy market[2].

Key Takeaways

• Established Use: Trileptal is well-established in the treatment of partial-onset seizures in adults and pediatric patients.
• Side Effects: The drug carries a risk of hyponatremia and requires genetic screening for HLA-B*1502 in at-risk populations.
• Market Dynamics: The epilepsy market is evolving with new therapies and generic competition, which may impact Trileptal's market share.
• Future Outlook: The growth of the epilepsy market will be influenced by new therapeutic options, regulatory changes, and economic factors.

FAQs

What are the primary indications for Trileptal?

Trileptal is indicated for the treatment of partial-onset seizures in adults and pediatric patients as monotherapy or adjunctive therapy[1].

What is the typical dosage for Trileptal?

For adults, the initial dose is 600 mg/day, given twice a day, with possible increments to a maximum of 1200 mg/day. For pediatric patients, the dose is weight-based, starting at 8-10 mg/kg/day[1].

What are the common side effects of Trileptal?

One of the notable side effects is hyponatremia (low sodium levels), which can occur in approximately 2.5% of patients. Other side effects include central nervous system (CNS) effects and the risk of severe skin reactions in genetically predisposed individuals[1].

How does Trileptal compare to newer antiepileptic drugs?

Trileptal is an established drug, but newer therapies may offer superior efficacy or safety profiles. The market position of Trileptal will depend on how these new drugs are adopted and their impact on treatment algorithms.

What is the future outlook for the epilepsy market?

The epilepsy market is expected to grow due to increasing prevalence and the development of new therapeutic options. However, the specific growth trajectory for Trileptal will be influenced by factors such as generic competition and the uptake of newer drugs.

Sources

1. Drugs.com: Trileptal: Package Insert / Prescribing Information.
2. GlobalData: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
3. Marinus Pharmaceuticals: Marinus Pharmaceuticals Provides Update on the Phase 3 RAISE Trial and Reports Preliminary First-Quarter 2024 Financial Results.
4. Oxford Academic: Double-blind, randomized, placebo-controlled prophylaxis trial of oxcarbazepine.
5. GlobeNewswire: Clinical Trial Supplies Industry Forecast Report 2025-2033.