Status:
TERMINATED
EXTENT: EXtended Tolerability and Efficacy of a Novel Formulation of Oxcarbazepine in a Trial in Partial Epilepsy
Lead Sponsor:
Desitin Arzneimittel GmbH
Collaborating Sponsors:
FGK Clinical Research GmbH
Conditions:
Partial Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
This is a multi-centre, randomized, open-label, flexible-titration, controlled, parallel-group study to investigate the safety and efficacy of a novel modified release formulation of oxcarbazepine (OX...
Eligibility Criteria
Inclusion
- Female and male patients with minimal age of 18 years on the date of the first study visit.
- Stable treatment with Oxcarbazepine treatment (Timox® /Trileptal®), dosage: exactly 900 mg or exactly 1200 mg or exactly 1500 mg for at least 1 month prior to screening.
- \>= 2 partial onset seizures with or without secondary generalisation refractory to existing AED therapy within the baseline period.
- Weight between \>= 50 kg and \< 100 kg.
- for females with child-bearing potential: negative pregnancy rest and highly effective form of birth control (females using hormonal contraceptives should use a different or additional means of birth control, e.g. IUD, abstinence, vasectomized partner, double barriere methods with or without oral contraceptives)
- Stable regimen of \<= 2 concomitant AEDs (vagus nerve stimulator included) during the baseline period; lamotrigine dose may be adjusted at baseline.
- Ethnic origin: Caucasian.
- Subjects capable of complying with the study stipulations.
- Patients who have provided written informed consent to participate in this study.
Exclusion
- Epilepsy secondary to progressive metabolic disease, malignant neoplasm, substance abuse, or active infection.
- Status epilepticus at any time during the baseline period.
- Lennox-Gastaut syndrome.
- Generalized epilepsy as primary diagnosis.
- Severe cardiac, pulmonary, haematological, hepatic, renal or neoplastic pathology.
- Acute medical conditions and/or conditions that could interfere with the absorption, metabolism or excretion of oxcarbazepine.
- History of clinically relevant psychiatric illness and/or drug abuse, drug addiction or alcoholism within the last 2 years.
- Treatment with psychotropic drugs, anticholinergic drugs, anti-parkinson medication, α1-antagonists, α2-antagonists, carbamazepine, topiramate, felbamate, vigabatrin. Stable treatment with selective serotonin-reuptake-inhibitor (SSRI) having been given for at least 4 weeks prior to screening as supportive treatment of partial epilepsy can be accepted.
- Intake of sodium lowering medication, e.g. diuretics and non-steroidal anti- inflammatory drugs. Occasional and short-term intake of non-steroidal anti- inflammatory drugs on demand (Ibuprofen, Paracetamol, ASS, Diclofenac and others) is allowed.
- Hypersensitivity towards oxcarbazepine or chemically related drugs.
- Low sodium serum levels (\< 128 mmol/L). Sodium serum levels ≥ 126 and \< 128 mmol/L can be accepted for inclusion, if these levels have been stable for at least 3 months.
- Symptomatic hyponatremia.
- Pregnancy or breast feeding.
- Participation in drug trials during 3 months preceding the study.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00391534
Start Date
October 1 2006
End Date
November 1 2009
Last Update
April 15 2010
Active Locations (6)
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1
Bergisch Gladbach, Germany
2
Bonn, Germany
3
Erlangen, Germany
4
Freiburg im Breisgau, Germany