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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR TOPIRAMATE

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Clinical Trials for Topiramate

Trial ID Title Status Sponsor Phase Summary
NCT00001725 Studies of Dextromethorphan and Topiramate to Treat Oral and Facial Pain Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 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 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 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 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.
NCT00004807 Study of the Pathogenesis of Rett Syndrome Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) N/A 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.
NCT00006205 Alcohol Dependency Study: Combining Medication Treatment for Alcoholism Unknown status National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
NCT00006205 Alcohol Dependency Study: Combining Medication Treatment for Alcoholism Unknown status Bankole Johnson Phase 2 The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Topiramate

Condition Name

Condition Name for Topiramate
Intervention Trials
Epilepsy 38
Migraine 29
Obesity 24
Seizures 20
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Condition MeSH

Condition MeSH for Topiramate
Intervention Trials
Migraine Disorders 42
Epilepsy 38
Disease 28
Alcoholism 27
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Clinical Trial Locations for Topiramate

Trials by Country

Trials by Country for Topiramate
Location Trials
United States 276
Canada 19
France 6
Brazil 6
Poland 4
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Trials by US State

Trials by US State for Topiramate
Location Trials
California 23
Virginia 18
Pennsylvania 17
Ohio 15
Florida 13
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Clinical Trial Progress for Topiramate

Clinical Trial Phase

Clinical Trial Phase for Topiramate
Clinical Trial Phase Trials
Phase 4 54
Phase 3 62
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Topiramate
Clinical Trial Phase Trials
Completed 161
Recruiting 28
Terminated 19
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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 Drug Abuse (NIDA) 13
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Sponsor Type

Sponsor Type for Topiramate
Sponsor Trials
Other 178
Industry 152
NIH 41
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