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Sponsored by: |
Desitin Arzneimittel GmbH |
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Information provided by: | Desitin Arzneimittel GmbH |
ClinicalTrials.gov Identifier: | NCT00391534 |
This study is intended to investigate the safety and efficacy of a novel formulation of oxcarbazepine that is released more slowly than the current formulation. The study medication will be used as a treatment against partial epilepsy.
Condition | Intervention | Phase |
---|---|---|
Partial Epilepsy |
Drug: modified release formulation of oxcarbazepine (OXC MR) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of a Novel Modified Release Formulation of Oxcarbazepine (OXC MR) vs an Immediate Release Oxcarbazepine (OXC IR) Product in Patients With Partial Epilepsy |
Estimated Enrollment: | 100 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2009 |
This is a multi-centre (5 centres), randomized, open-label, flexible-titration, controlled, parallel-group study to investigate the safety and efficacy of a novel modified release formulation of oxcarbazepine (OXC MR) compared to an immediate release oxcarbazepine (OXC IR) product in patients with partial epilepsy. Adult patients of both gender, aged at least 18 years with refractory partial epilepsy, with or without secondary generalisation receiving a stable background treatment with daily dosages of exactly 900 or 1200 mg Oxcarbazepine will be enrolled. Concomitant medication consisting of maximal 2 additional AEDs (vagus nerve stimulator included) is allowed and must be kept stable throughout the study. Patients, who agree to participate, will first sign and date the informed consent and undergo an evaluation at screening visit to determine eligibility. Those patients who qualify will be enrolled in the study, assigned a patient ID, and will enter the 4-week baseline period. Each patient will receive a seizure diary to record the number of seizures during the baseline period. For Visit 1 the patient will return to the clinic and complete all baseline procedures. Patients who have met the entry criteria will be randomised. The two treatment groups consist of 50 patients each, one group to be treated with OXC MR b.i.d. and the other to be treated with OXC IR b.i.d. in a 1:1 randomization. Following assignment to one of both treatment groups the patient will enter the dose-titration phase. From Visit 1 (Study Day 1) a total daily dose of 1200 mg /1500 mg oxcarbazepine will be given to the randomised patients. From Day 6 the dosage will be titrated to a maximum total daily dose of 2700 mg in steps of 300 mg every 6th day. Patients who experienced intolerable adverse events could reduce their daily dose by 150 mg on the 2nd day of up-titration for the remainder of the treatment period. In case the reduced dosage will also not be tolerated, in a second step the dosage can be reduced by further 150 mg OXC. The maximal tolerated dose achieved on up-titration will be maintained up to the final visit (Study Day 26).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dr. Martina Wangemann Wangemann, PhD | +49 40 59101 ext 396 | Wangemann@Desitin.de |
Germany | |
Klinik für Epileptologie, Universität Bonn | Recruiting |
Bonn, Germany, 53127 | |
Principal Investigator: Christian E. Elger, Prof. MD |
Principal Investigator: | Christian E. Elger, Prof. MD | Klinik für Epileptologie, Universität Bonn, Bonn, Germany |
Study Director: | Martina Wangemann, Dr. | Desitin Arzneimittel GmbH |
Study ID Numbers: | OXC-039/K, EudraCT No: 2006-003834-14 |
Study First Received: | October 23, 2006 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00391534 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Epilepsy oxcarbazepine |
Epilepsies, Partial Oxcarbazepine Carbamazepine |
Epilepsy Central Nervous System Diseases Brain Diseases |
Tranquilizing Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |