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Last Updated: July 12, 2025

CLINICAL TRIALS PROFILE FOR TOPIRAMATE


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All Clinical Trials for Topiramate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001725 ↗ Studies of Dextromethorphan and Topiramate to Treat Oral and Facial Pain Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 1997-12-01 This study will evaluate the safety and effectiveness of two drugs-dextromethorphan and topiramate-in treating orofacial (mouth and face) pain. Dextromethorphan, a commonly used cough suppressant, and topiramate, an anti-seizure medicine, block certain receptors on brain and spinal nerve cells that may cause the cells to produce electrical discharges and pain. Patients 18 years of age and older with oral and facial pain with trigeminal nerve damage and who have had pain daily for at least 3 months may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests and psychiatric evaluation. These results will serve as baseline values for participants. Those enrolled in the study will take either dextromethorphan or topiramate in a 2-part study as follows: Dextromethorphan In Part 1, patients will take dextromethorphan and lorazepam (a commonly used anti-anxiety drug) separately in two 6-week periods. (Lorazepam is used in this study as an "active placebo" for comparison with dextromethorphan. An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug.) They will take dextromethorphan for 4 weeks to determine the maximum tolerated dose (the highest dose that does not cause troubling side effects) and will stay on that dose for the remaining 2 weeks. Then they will repeat this process with lorazepam. Patients who respond to either drug may continue with Part 2 of the study, which compares these two drugs four more times to confirm the response seen in Part 1. In Part 2, the maximum tolerated dose will be determined in a 2-week period and that dose will be continued for another 2 weeks. This procedure will be repeated eight times. Throughout the study, patients will keep a daily pain diary. They will be contacted by telephone 2 to 3 times a week during dose escalation to check for side effects. At the end of each of the two 6-week periods in Part 1 and at the end of each 4-week period in Part 2 of the study, patients will have a 1-hour clinic visit. Participants who live more than a few hours' drive from NIH will have a full telephone follow-up evaluation instead of the clinic visits. Topiramate Patients who receive topiramate will follow a plan similar to that described above for dextromethorphan, with the following exceptions. They will take topiramate and an inactive placebo (a look-alike pill that has no active ingredients) in two separate 12-week periods. Patients' maximum tolerated dose will be determined in the first 8 weeks and they will stay on that dose for the remaining 4 weeks of each period. Patients who respond to the medication in Part 1 may continue with Part 2 to confirm the response. Part 2 consists of six 6-week periods. The first 4 weeks of each will be used to determine the maximum tolerated dose and the patient will remain on that dose for the next 2 weeks. Patients will keep a daily pain diary and will be contacted by phone 2 to 3 times a week while doses are being increased. Patients who complete Part 2 of the topiramate study may participate in another phase of the study that will last for 2 years. Those who continue for this phase will take topiramate for the 2-year period. They will be followed regularly by a study nurse and will come to NIH every 6 months for a follow-up visit.
NCT00004776 ↗ Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome Completed University of California, Los Angeles Phase 3 1993-11-01 OBJECTIVES: I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome.
NCT00004776 ↗ Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome Completed National Center for Research Resources (NCRR) Phase 3 1993-11-01 OBJECTIVES: I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome.
NCT00004807 ↗ Study of the Pathogenesis of Rett Syndrome Completed Johns Hopkins University N/A 1995-01-01 OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome (RS). II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine, while continuing supportive care to modify seizures, respiratory abnormalities, and motor disturbances, and improve nutrition, behavior, and learning. IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence neurologic recovery.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Topiramate

Condition Name

Condition Name for Topiramate
Intervention Trials
Migraine 39
Epilepsy 38
Obesity 32
Seizures 20
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Condition MeSH

Condition MeSH for Topiramate
Intervention Trials
Migraine Disorders 57
Epilepsy 45
Alcoholism 31
Disease 30
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Clinical Trial Locations for Topiramate

Trials by Country

Trials by Country for Topiramate
Location Trials
United States 316
Canada 23
Poland 10
Germany 9
France 8
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Trials by US State

Trials by US State for Topiramate
Location Trials
California 30
Pennsylvania 19
Virginia 19
Ohio 18
Florida 15
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Clinical Trial Progress for Topiramate

Clinical Trial Phase

Clinical Trial Phase for Topiramate
Clinical Trial Phase Trials
Phase 4 66
Phase 3 70
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Topiramate
Clinical Trial Phase Trials
Completed 186
Terminated 29
Recruiting 26
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Clinical Trial Sponsors for Topiramate

Sponsor Name

Sponsor Name for Topiramate
Sponsor Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 52
Ortho-McNeil Neurologics, Inc. 21
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 14
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Sponsor Type

Sponsor Type for Topiramate
Sponsor Trials
Other 257
Industry 160
NIH 51
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Topiramate: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction to Topiramate

Topiramate is a versatile medication primarily used as an anticonvulsant for the treatment of various neurological conditions, including epilepsy, migraines, and bipolar disorder. It is also used for weight loss in some cases. Here, we will delve into the current clinical trials, market analysis, and future projections for topiramate.

Clinical Trials Update

Ongoing and Recent Studies

One of the significant ongoing clinical trials involves comparing the safety and tolerability of atogepant versus topiramate in participants with migraines. This study, conducted globally across approximately 85 sites, aims to evaluate how patients handle these treatments and their safety profiles. Participants are randomly assigned to receive either atogepant or topiramate for 24 weeks, followed by a 52-week period where all eligible participants receive atogepant. The study monitors safety through medical assessments, blood tests, and questionnaires[1].

Safety and Tolerability

Historical data from large, randomized, double-blind, placebo-controlled trials have shown that topiramate is generally well-tolerated for migraine prevention. The most common adverse events (AEs) associated with topiramate are mild or moderate and include paresthesia, fatigue, nausea, and difficulty with concentration. Serious AEs are infrequent, occurring in about 2% of topiramate-treated patients. These studies also highlighted significant reductions in mean migraine frequency compared to placebo, with topiramate 100 mg/day being the recommended target dose for most patients[3].

Market Analysis

Market Size and Growth

The topiramate market is expected to grow steadily, with a projected Compound Annual Growth Rate (CAGR) of around 2.98% from 2024 to 2032. This growth is driven by the increasing adoption of advanced technologies, the presence of large industry players, and rising demand for effective therapeutic solutions for neurological disorders. The market size is anticipated to reach approximately $6.3 billion by 2032[2].

Key Market Segments

The topiramate market can be segmented by application (epilepsy, migraines, bipolar disorder, weight loss), formulation (tablets, oral solution, injectable), strength (25 mg, 50 mg, 100 mg, 200 mg), distribution channel (hospital pharmacies, retail pharmacies, online pharmacies), and end user (patients, hospitals, clinics). The market is also analyzed geographically, with major regions including North America, Europe, Asia-Pacific, South America, Middle East, and Africa[2].

Competitive Landscape

The topiramate market is highly competitive, with key players such as Johnson & Johnson, Novartis, Teva Pharmaceutical Industries, Mylan, Apotex, Sandoz, Hikma Pharmaceuticals, Lupin, Dr. Reddy's Laboratories, Sun Pharmaceutical Industries, Zydus Pharmaceuticals, Boehringer Ingelheim, Merck & Co., GlaxoSmithKline, and Pfizer. These companies are investing heavily in research and development to enhance product formulations and expand their market presence[2].

Market Projections

Future Growth Drivers

The future growth of the topiramate market is expected to be driven by several factors:

  • Increasing Prevalence of Neurological Disorders: The global rise in neurological conditions such as epilepsy and migraines is creating a growing demand for effective treatments.
  • Technological Innovations: Advances in drug formulations and delivery systems are likely to optimize the performance of topiramate, making it more widely used.
  • Expanding Healthcare Infrastructure: Investments in healthcare infrastructure, particularly in developing nations, will provide new opportunities for market expansion[5].

Emerging Trends and Opportunities

  • Enhanced Formulations: Ongoing research is focused on developing new and improved formulations of topiramate, such as extended-release capsules, which can offer better patient compliance and efficacy.
  • Untapped Markets: There are significant opportunities in untapped geographic regions, particularly in emerging markets where access to advanced medications is increasing.
  • Strategic Investments: Companies are making strategic investments in product development, marketing, and distribution channels to capture a larger market share[5].

Precautions and Considerations

Safety and Side Effects

While topiramate is generally well-tolerated, it can cause several side effects, including vision changes, clumsiness, dizziness, drowsiness, and trouble with thinking or speaking. It is crucial for patients to undergo regular medical assessments and blood tests to monitor for these effects. Topiramate can also exacerbate conditions such as metabolic acidosis, kidney disease, and liver disease, requiring careful dose adjustments and monitoring[4].

Special Populations

Topiramate's safety and efficacy have not been established in children younger than 12 years for migraine prevention and younger than 2 years for seizure treatment. In geriatric patients, caution is advised due to potential age-related kidney problems. Additionally, topiramate may not be suitable for pregnant or breastfeeding women due to potential risks to the fetus or infant[4].

Key Takeaways

  • Clinical Trials: Ongoing trials are comparing the safety and tolerability of topiramate with other medications like atogepant.
  • Market Growth: The topiramate market is projected to grow at a CAGR of 2.98% from 2024 to 2032.
  • Market Segments: The market is segmented by application, formulation, strength, distribution channel, and end user.
  • Competitive Landscape: The market is highly competitive with several major pharmaceutical companies.
  • Future Drivers: Growth will be driven by increasing neurological disorders, technological innovations, and expanding healthcare infrastructure.
  • Precautions: Patients need to be monitored for side effects, and special populations require careful consideration.

FAQs

What are the primary uses of topiramate?

Topiramate is primarily used for the treatment of epilepsy, prevention of migraines, and in some cases, for bipolar disorder and weight loss.

What are the common side effects of topiramate?

Common side effects include paresthesia, fatigue, nausea, and difficulty with concentration. Serious side effects are infrequent but can include vision changes, clumsiness, and metabolic acidosis.

How is the topiramate market expected to grow?

The topiramate market is expected to grow at a CAGR of around 2.98% from 2024 to 2032, reaching approximately $6.3 billion by 2032.

Who are the key players in the topiramate market?

Key players include Johnson & Johnson, Novartis, Teva Pharmaceutical Industries, Mylan, Apotex, Sandoz, and several other major pharmaceutical companies.

What are the future growth drivers for the topiramate market?

Future growth will be driven by the increasing prevalence of neurological disorders, technological innovations, and expanding healthcare infrastructure in developing nations.

Are there any special precautions for using topiramate in certain populations?

Yes, topiramate's safety and efficacy have not been established in children under 12 years for migraine prevention and under 2 years for seizure treatment. Geriatric patients and pregnant or breastfeeding women require careful consideration and monitoring.

Sources

  1. Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events and Disease Activity. ClinicalTrials.gov.
  2. Topiramate Market Growth Drivers and Industry Outlook 2024 To 2032. OpenPR.
  3. Analysis of Safety and Tolerability Data Obtained from Over 1,500 Patients with Migraine. Pain Medicine, Oxford Academic.
  4. Topiramate (oral route). Mayo Clinic.
  5. Topiramate Drugs Market Size & Share 2025-2030. 360 Research Reports.

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