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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00210535 |
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the prevention of migraine attacks in children (12 to 17 years of age).
Condition | Intervention | Phase |
---|---|---|
Migraine Vascular Headaches |
Drug: topiramate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Topiramate for the Prophylaxis of Migraine in Pediatric Subjects 12 to 17 Years of Age |
Estimated Enrollment: | 102 |
Study Start Date: | June 2005 |
Study Completion Date: | November 2006 |
This is an outpatient, randomized, double-blind, placebo-controlled study to evaluate the effectiveness of 2 dosages of topiramate (50 and 100 milligrams/day) compared with placebo in the prevention of migraine attacks in children 12 to 17 years of age. The study is composed of 3 phases: pretreatment, double-blind treatment for 4 months (16 weeks), and posttreatment. During the study, patients will maintain headache and medication records to document the following: occurrence and duration of headaches; severity of headache pain; whether or not the headache is pulsating or aggravated by physical activity; associated symptoms, such as nausea, vomiting, photophobia, phonophobia, abdominal pain; and medication taken to relieve headache pain or symptoms. Assessment of efficacy include the percent reduction in the frequency of monthly migraine attacks over the last 12 weeks of the double-blind treatment phase compared with the pretreatment phase. In addition, the percent reduction in (a) average monthly migraine days, (b) average monthly headache days, and (c) monthly migraine rate, over the last 12 weeks of the double-blind treatment phase compared with the pretreatment phase will be assessed. Safety assessments include the incidence of adverse events, measurement of vital signs (pulse, blood pressure, oral temperature), results of pregnancy tests, physical and neurologic examinations, clinical laboratory tests (hematology, biochemistry, and urinalysis), and monitoring for signs of vision abnormalities. The study hypothesis is that the percent reduction in frequency of monthly (28-day) migraine attacks (using the 48-hour rule) from the prospective baseline period (pretreatment phase) to the last 12 weeks of the double-blind phase will be significantly better for the topiramate groups than for the placebo group.
Topiramate tablets (25 milligrams) or placebo, beginning at 25mg once daily (Week 1), increasing to twice daily total of 50mg or 100mg (Week 4). Maximum dosage of topiramate (or placebo) continues for next 12 weeks. Dosage may be reduced once at investigator's discretion.
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR002245 |
Study First Received: | September 13, 2005 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00210535 History of Changes |
Health Authority: | United States: Food and Drug Administration |
migraine prevention migraine headache topiramate migraine pediatric |
Vascular Headaches Vascular Diseases Central Nervous System Diseases Headache Disorders, Primary Pain Brain Diseases Neuroprotective Agents Cerebrovascular Disorders Headache Disorders |
Anti-Obesity Agents Signs and Symptoms Headache Disorders, Secondary Migraine Disorders Headache Neoplasm Metastasis Topiramate Neurologic Manifestations Anticonvulsants |
Physiological Effects of Drugs Vascular Headaches Nervous System Diseases Vascular Diseases Central Nervous System Diseases Headache Disorders, Primary Pain Brain Diseases Protective Agents Neuroprotective Agents Cerebrovascular Disorders Pharmacologic Actions |
Headache Disorders Anti-Obesity Agents Signs and Symptoms Headache Disorders, Secondary Migraine Disorders Therapeutic Uses Headache Topiramate Neurologic Manifestations Cardiovascular Diseases Central Nervous System Agents Anticonvulsants |