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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: | NCT00231673 |
The purpose of the study is to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy. The study will also evaluate the safety of topiramate in this patient population.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 Polyneuropathies Diabetic Neuropathies |
Drug: topiramate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Topiramate on Electrophysicological Parameters in Subjects With Diabetic Peripheral Polyneuropathy |
Estimated Enrollment: | 72 |
Study Start Date: | February 2001 |
Estimated Study Completion Date: | January 2003 |
This is a multicenter, double-blind, placebo-controlled study to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy. Patients will undergo the Baseline Phase when they are tapered off other pain medications, have diabetes controlled and eligibility reassessed. Patients will then be randomized to receive either topiramate or placebo and enter the Double-Blind Phase, which consists of Titration Period (topiramate dose will be titrated from 25mg/day to 200mg/day over 42 days) and Maintenance Period (study medication will be continued for 12 weeks). After the Double-Blind Phase, study medication will be tapered off during the Taper Phase, whose duration will vary depending on each patient. The evaluations include electrophysiological assessment, quantitative sensory assessment, and clinical assessment such as subjective pain scales. Safety evaluations (vital signs, clinical laboratory evaluations, physical and neurological examination, and evaluations of adverse events) will be conducted during the trial.
During the first 42 days, doses of topiramate gradually increase to achieve the target dose (200mg daily by mouth), and then the dose is maintained for 12 weeks, after which the dose is slowly reduced and stopped over 12 weeks.
Ages Eligible for Study: | 18 Years to 75 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: | CR003202 |
Study First Received: | September 30, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00231673 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurological Examination Electrophysiology Diabetic peripheral polyneuropathy |
Quantitative Sensory Testing Nerve Conduction Study Topiramate |
Metabolic Diseases Diabetic Neuropathies Polyneuropathies Diabetes Mellitus Endocrine System Diseases Neuroprotective Agents Anti-Obesity Agents Neuromuscular Diseases |
Peripheral Nervous System Diseases Diabetes Mellitus, Type 2 Topiramate Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Anticonvulsants Diabetes Complications |
Metabolic Diseases Diabetic Neuropathies Physiological Effects of Drugs Nervous System Diseases Diabetes Mellitus Polyneuropathies Endocrine System Diseases Protective Agents Neuroprotective Agents Pharmacologic Actions |
Anti-Obesity Agents Neuromuscular Diseases Therapeutic Uses Peripheral Nervous System Diseases Diabetes Mellitus, Type 2 Topiramate Glucose Metabolism Disorders Central Nervous System Agents Diabetes Complications Anticonvulsants |