CLINICAL TRIALS PROFILE FOR TEGRETOL

All Clinical Trials for Tegretol

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.
NCT00006395 ↗	Drug Interaction Study of Tegretol (Carbamazepine) and St. John's Wort in Normal Volunteers	Completed	National Institutes of Health Clinical Center (CC)	Phase 4	2000-10-01	St. John's Wort is a popular dietary supplement that many patients-including those with epilepsy or seizures-take in addition to their regular medicines to elevate mood or relieve stress. Preliminary research indicates that this supplement can speed the metabolism of the anti-seizure drug Tegretol, causing reduced blood levels of the drug. Patients who take Tegretol to control their seizures may have more frequent seizures if the blood level of the drug drops too low. A recent study shows that this effect is not seen when Tegretol is taken for at least 3 weeks. The present study will examine whether there is a medically important drug interaction between St. John's wort and Tegretol when Tegretol is taken for 1 day. Normal healthy volunteers between 21 and 65 years old who are not taking medicines that can affect the metabolism of drugs in the liver and have not used St. John's wort for at least 30 days may be eligible for this 25-day study. Participants will take a 400-mg dose of Tegretol after fasting overnight. Blood samples will be drawn the next day during a 12-hour clinic stay at the following intervals: just before the Tegretol dose and at 1, 2, 4, 6, 8, 10, 24, 34, 48 and 72 hours after the dose. A catheter will be placed in the vein to prevent the need for multiple needle sticks until after the 10-hour sample. After completing the blood sampling, participants will take 300 mg of St. John's wort 3 times a day with meals for 2 weeks. After 2 weeks, another fasting dose of Tegretol will be given and the 72-hour blood study will be repeated. This study may provide information important for the care of patients with epilepsy who take both Tegretol and St. John's Wort.
NCT00108069 ↗	Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors	Completed	National Cancer Institute (NCI)	Phase 2	2005-04-01	This study will determine whether the drugs tamoxifen and bortezomib can delay tumor growth in patients with recurrent glioma (malignant brain tumor). Tamoxifen may work by interfering with the internal signaling needed for the cancer to grow. Bortezomib may also interfere with tumor growth processes. Laboratory studies show that low doses of bortezomib significantly enhance glioma cell death when used with tamoxifen. Patients 18 years of age and older with glioma whose tumor does not respond to standard medical treatment and who are not taking enzyme-inducing anti-seizure medications such as Dilantin, phenobarbitol, or Tegretol, may be eligible for this study. Candidates are screened with a physical examination, blood tests, and magnetic resonance imaging (MRI) or computed tomography (CT). MRI and CT scans produce images of the brain that can show if the brain tumor is growing (see below). Participants receive treatment in 6-week cycles for up to 1 year. (The treatment duration may be extended in some patients who continue to tolerate the drug and show no signs of tumor growth after 1 year.) During each cycle, patients take six tamoxifen tablets twice a day every day and receive bortezomib by infusion into a vein on days 3, 6, 10, 13, 24, 27, 31 and 34. Treatment may continue as long as the tumor does not grow and the patient does not develop unacceptable side effects. In addition to drug treatment, patients undergo the following tests and procedures: - Periodic routine blood tests. - 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. - Blood test to measure levels of bortezomib. Blood is drawn before the bortezomib infusion on days 3 and 24, and 4 hours after the infusion on day 24 of the first treatment cycle only. - Dynamic MRI with spectroscopy or positron emission tomography (PET). Patients may be asked to undergo one of these tests, which 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 (see above). 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. - Drug diary. Patients maintain a calendar to record when they take their study drugs and what side effects they develop.

Clinical Trial Conditions for Tegretol

Condition Name

Condition Name for Tegretol
Intervention	Trials
Epilepsy	5
Gliosarcoma	3
Healthy	2
Focal Epilepsy	2

Condition MeSH

Condition MeSH for Tegretol
Intervention	Trials
Epilepsy	7
Glioma	4
Gliosarcoma	3
Glioblastoma	3

Clinical Trial Locations for Tegretol

Trials by Country

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

Trials by US State

Trials by US State for Tegretol
Location	Trials
North Carolina	4
Maryland	2
California	1
Connecticut	1
Virginia	1

Clinical Trial Progress for Tegretol

Clinical Trial Phase

Clinical Trial Phase for Tegretol
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	2

Clinical Trial Status

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

Clinical Trial Sponsors for Tegretol

Sponsor Name

Sponsor Name for Tegretol
Sponsor	Trials
Duke University	3
National Cancer Institute (NCI)	2
Eisai Limited	1

Sponsor Type

Sponsor Type for Tegretol
Sponsor	Trials
Other	23
Industry	11
NIH	4

Tegretol (Carbamazepine): Clinical Trials, Market Analysis, and Projections

Introduction to Tegretol (Carbamazepine)

Tegretol, commonly known by its generic name carbamazepine, is a versatile medication used in the treatment of various neurological and psychiatric conditions. It is widely recognized for its efficacy in managing epilepsy, trigeminal neuralgia, and as a prophylaxis for manic-depressive psychosis[4].

Clinical Trials and Efficacy

Trigeminal Neuralgia

A notable study on the use of Tegretol in treating trigeminal neuralgia involved 30 patients, with all patients becoming pain-free within 24 hours of receiving the medication. The study, conducted from 1965 to 1968, showed that 28 patients had complete remission of pain with no recurrences over a period ranging from 19 months to three years. However, two patients experienced recurrence of pain, which was eventually relieved after neurolysis. The study highlighted the effectiveness of Tegretol in managing trigeminal neuralgia with minimal adverse effects[1].

Mechanism of Action

Tegretol has been shown to inhibit polysynaptic transmission in both the spinal trigeminal nucleus and the centrum medianum of the thalamus. This inhibition is more pronounced in the centrum medianum, although it is not certain if this is the primary site of action[1].

Market Analysis

Global Market Size and Growth

The global carbamazepine market is projected to grow significantly over the coming years. As of 2022, the market was valued at approximately $713.4 million and is expected to reach $892.6 million by 2029, with a Compound Annual Growth Rate (CAGR) of 3.3% during the period from 2023 to 2029[2].

Key Players

The market is dominated by several key manufacturers, including Novartis, Apotex Corporation, Teva, Biomed Pharma, Nucare Pharmaceuticals, and Taro Pharmaceuticals. These top players ensure a significant supply of carbamazepine worldwide[2].

Market Trends

The increasing demand for effective treatments for neurological and psychiatric disorders, such as epilepsy, bipolar disorder, and trigeminal neuralgia, drives the growth of the carbamazepine market. Additionally, the expansion of healthcare infrastructure and government initiatives supporting drug development contribute to the market's growth[5].

Market Projections

Future Outlook

By 2025, the carbamazepine market is expected to continue its upward trend, driven by the increasing prevalence of chronic diseases and the need for effective treatments. The market is also influenced by advancements in clinical trials and regulatory approvals, such as the FDA's approval of carnexiv in 2016[2][5].

Competitive Landscape

The vendor landscape of the global carbamazepine market is highly competitive, with key vendors focusing on product specification, portfolio expansion, and financial stability. The market analysis includes a detailed assessment of the strengths, weaknesses, opportunities, and threats (SWOT analysis) of these vendors, providing insights into their strategies and future prospects[5].

Safety and Genomic Considerations

Genomic Testing

For patients of Han Chinese and Thai origin, it is recommended to screen for the HLA-B15:02 allele before starting carbamazepine treatment due to the risk of severe cutaneous adverse reactions. However, there is currently insufficient data to recommend HLA-A31:01 screening[4].

Adverse Effects

Common adverse effects associated with Tegretol include lethargy, headache, nausea, and light-headedness. In rare cases, more severe reactions such as erythematous rash and abnormal laboratory test results may occur, necessitating careful monitoring and adjustment of treatment[1].

Conclusion

Tegretol (carbamazepine) remains a crucial medication in the treatment of various neurological and psychiatric conditions. Its efficacy, as demonstrated in clinical trials, and its growing market demand underscore its importance in healthcare.

Key Takeaways

• Efficacy in Trigeminal Neuralgia: Tegretol is highly effective in managing trigeminal neuralgia, with most patients experiencing complete remission of pain.
• Market Growth: The global carbamazepine market is projected to reach $892.6 million by 2029, driven by increasing demand for neurological treatments.
• Key Players: Major pharmaceutical companies like Novartis, Apotex Corporation, and Teva dominate the market.
• Safety Considerations: Genomic testing for HLA-B*15:02 is recommended for certain populations, and patients should be monitored for potential adverse effects.

FAQs

What is Tegretol used for?

Tegretol (carbamazepine) is used to treat epilepsy, trigeminal neuralgia, and as a prophylaxis for manic-depressive psychosis. It is also used for various other neurological and psychiatric conditions[4].

What are the common adverse effects of Tegretol?

Common adverse effects include lethargy, headache, nausea, and light-headedness. Rare but more severe reactions such as erythematous rash and abnormal laboratory test results can also occur[1].

Why is genomic testing recommended for some patients taking Tegretol?

Genomic testing for the HLA-B*15:02 allele is recommended for patients of Han Chinese and Thai origin to prevent severe cutaneous adverse reactions[4].

What is the projected growth of the global carbamazepine market?

The global carbamazepine market is expected to grow from $713.4 million in 2022 to $892.6 million by 2029, with a CAGR of 3.3% during the period from 2023 to 2029[2].

Who are the key players in the carbamazepine market?

Key players include Novartis, Apotex Corporation, Teva, Biomed Pharma, Nucare Pharmaceuticals, and Taro Pharmaceuticals[2].

What is the significance of the FDA's approval of carnexiv?

The FDA's approval of carnexiv in 2016 highlights the ongoing development and regulatory support for carbamazepine-based treatments, contributing to the market's growth[2].

Last updated: 2025-01-03