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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR TEGRETOL-XR


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All Clinical Trials for Tegretol-xr

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000441 ↗ Drug Therapy for Alcohol Detoxification Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 4 1969-12-31 This project will provide relevant clinical information for primary care practitioners treating alcohol withdrawal syndrome in outpatient settings. This double-blind, placebo- controlled clinical trial will compare the effectiveness of lorazepam (Ativan) and carbamazepine (Tegretol) in alcoholics who meet the criteria for a diagnosis of uncomplicated alcohol withdrawal syndrome. Participants are randomized to five days of treatment with a 1-week posttreatment followup.
NCT00005951 ↗ Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma Completed National Cancer Institute (NCI) Phase 1 2000-08-01 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 trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.
NCT00005951 ↗ Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma Completed Duke University Phase 1 2000-08-01 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 trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tegretol-xr

Condition Name

Condition Name for Tegretol-xr
Intervention Trials
Epilepsy 5
Gliosarcoma 3
Healthy 2
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Condition MeSH

Condition MeSH for Tegretol-xr
Intervention Trials
Epilepsy 7
Glioma 4
Glioblastoma 3
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Clinical Trial Locations for Tegretol-xr

Trials by Country

Trials by Country for Tegretol-xr
Location Trials
United States 14
China 2
Indonesia 2
Belgium 2
Korea, Republic of 2
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Trials by US State

Trials by US State for Tegretol-xr
Location Trials
North Carolina 4
Maryland 2
California 1
Connecticut 1
Virginia 1
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Clinical Trial Progress for Tegretol-xr

Clinical Trial Phase

Clinical Trial Phase for Tegretol-xr
Clinical Trial Phase Trials
Phase 4 13
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Tegretol-xr
Clinical Trial Phase Trials
Completed 19
Recruiting 3
Unknown status 1
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Clinical Trial Sponsors for Tegretol-xr

Sponsor Name

Sponsor Name for Tegretol-xr
Sponsor Trials
Duke University 3
National Cancer Institute (NCI) 2
National Institutes of Health Clinical Center (CC) 1
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Sponsor Type

Sponsor Type for Tegretol-xr
Sponsor Trials
Other 23
Industry 11
NIH 4
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Tegretol-XR: Clinical Trials, Market Analysis, and Projections

Introduction to Tegretol-XR

Tegretol-XR, a extended-release formulation of carbamazepine, is a widely used medication for the treatment of various neurological conditions, including epilepsy, trigeminal neuralgia, and bipolar disorder. Here, we will delve into the clinical trials, market analysis, and future projections for Tegretol-XR.

Clinical Trials and Efficacy

Efficacy in Seizure Control

Clinical trials have consistently shown that Tegretol-XR is effective in the treatment of psychomotor and grand mal seizures. A multicenter, double-blind, crossover study compared Tegretol-XR with conventional Tegretol tablets in terms of trough plasma carbamazepine concentrations, seizure control, tolerability, and safety. The study found that 98% of patients had plasma carbamazepine concentrations within the recommended therapeutic range during Tegretol-XR treatment, and 97% did during Tegretol treatment. The seizure rate decreased in 26% of patients during both treatments, and remained the same in 48% of patients during Tegretol-XR therapy and in 52% during Tegretol therapy[3].

Mechanism of Action

Tegretol-XR acts by reducing polysynaptic responses and blocking the post-tetanic potentiation. It also depresses thalamic potential and bulbar and polysynaptic reflexes, including the linguomandibular reflex in cats. The principal metabolite of Tegretol, carbamazepine-10,11-epoxide, has anticonvulsant activity, although its clinical significance is not fully established[1][4].

Safety and Tolerability

While Tegretol-XR is generally well-tolerated, it carries risks such as aplastic anemia, agranulocytosis, and severe cutaneous reactions like Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Patients testing positive for the HLA-B*1502 allele are at a higher risk for SJS/TEN, particularly those of Chinese ancestry[4].

Pharmacokinetics

Absorption and Bioavailability

Tegretol-XR tablets are designed to release the drug slowly, providing steady-state plasma levels comparable to conventional Tegretol tablets given four times a day when administered at the same total daily dose. The bioavailability of Tegretol-XR tablets is 89% compared to the suspension. Plasma levels peak at approximately 3-12 hours after administration of Tegretol-XR tablets, compared to 1.5 hours for the suspension and 4-5 hours for conventional tablets[1][4].

Metabolism and Half-Life

Tegretol is metabolized in the liver, primarily by cytochrome P450 3A4, which forms the active metabolite carbamazepine-10,11-epoxide. The drug induces its own metabolism, leading to a variable half-life that decreases from 25-65 hours initially to 12-17 hours on repeated doses[1][4].

Market Analysis

Current Market Size and Growth

The global carbamazepine market, which includes Tegretol-XR, is projected to grow from US$ 713.4 million in 2022 to US$ 892.6 million by 2029, at a CAGR of 3.3% during the period of 2023 to 2029[5].

Regional Market Dynamics

The epilepsy treatment market, a significant segment for Tegretol-XR, is expected to expand to USD 15.36 billion by 2035, with a CAGR of 5.7% between 2025 and 2035. North America is the largest market, while the Asia Pacific region is the fastest-growing market due to increasing healthcare expenditure and awareness about neurological disorders[2].

Key Players

Major manufacturers in the carbamazepine market include Novartis, Apotex Corporation, Teva, Biomed Pharma, Nucare Pharmaceuticals, and Taro Pharmaceuticals. These companies play a crucial role in ensuring the global supply and development of carbamazepine products, including Tegretol-XR[5].

Market Projections

Future Growth Drivers

The growing prevalence of neurological disorders such as epilepsy and trigeminal neuralgia is expected to drive the demand for Tegretol-XR. Increasing awareness and better diagnostic tools will also contribute to market growth. Additionally, advancements in drug delivery systems and the development of new formulations may further enhance the market for carbamazepine products[2][5].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as the risk of severe adverse reactions and the need for genetic screening to identify at-risk patients. However, these challenges also present opportunities for innovation in safety monitoring and personalized medicine. The expanding healthcare infrastructure in emerging markets and the increasing focus on mental health treatments are other significant opportunities for growth[4][5].

Key Takeaways

  • Clinical Efficacy: Tegretol-XR is effective in controlling seizures and managing trigeminal neuralgia.
  • Pharmacokinetics: The extended-release formulation provides steady-state plasma levels, reducing the need for frequent dosing.
  • Market Growth: The global carbamazepine market is expected to grow at a CAGR of 3.3% from 2023 to 2029.
  • Regional Dynamics: North America is the largest market, while the Asia Pacific region is the fastest-growing.
  • Challenges and Opportunities: The market faces challenges related to safety, but also presents opportunities for innovation and growth in emerging markets.

FAQs

What is Tegretol-XR used for?

Tegretol-XR is used for the treatment of psychomotor and grand mal seizures, trigeminal neuralgia, and other neurological conditions.

What are the key differences between Tegretol-XR and conventional Tegretol tablets?

Tegretol-XR is an extended-release formulation that provides steady-state plasma levels with less frequent dosing compared to conventional tablets.

What are the potential side effects of Tegretol-XR?

Tegretol-XR can cause severe side effects such as aplastic anemia, agranulocytosis, and severe cutaneous reactions like SJS/TEN, especially in patients with the HLA-B*1502 allele.

How is the carbamazepine market projected to grow?

The global carbamazepine market is projected to grow from US$ 713.4 million in 2022 to US$ 892.6 million by 2029, at a CAGR of 3.3%.

Which regions are driving the growth of the epilepsy treatment market?

North America is the largest market, while the Asia Pacific region is the fastest-growing due to increasing healthcare expenditure and awareness.

Sources

  1. Tegretol Tegretol-XR Rx only Prescribing Information. FDA.
  2. Epilepsy Treatment Market Size, Share & Forecast 2025-2035. MetaTech Insights.
  3. Double-blind crossover comparison of Tegretol-XR and Tegretol tablets. PubMed.
  4. Tegretol® Tegretol®-XR Rx only Prescribing Information WARNINGS. Novartis.
  5. Carbamazepine Market: Size, Share, Growth, Analysis, Key Players, Revenue, Growth. OpenPR.

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