A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Refractory Partial Seizures - Not Applicable
- Conditions
- Refractory partial epilepsyMedDRA version: 12.0Level: LLTClassification code 10061334Term: Partial seizures
- Registration Number
- EUCTR2004-002069-19-BE
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
Male or female between 18 and 70 years, inclusive.
Weight >/= 40 kg.
Diagnosis of epilepsy for at least 1 year.
History of partial onset seizures, including complex partial and/or partial with secondary generalization and/or simple partial motor seizures.
History of having failed the use of at least 3 different AEDs, administered at appropriate doses and for sufficient treatment periods
In the judgment of the investigator, a history of an established pattern of persistent seizures that approximates a frequency of at least 3 partial onset seizures per month.
Concomitant treatment with 1 to 3 AEDs. The AED doses must have been stable over the past month.
Female subjects of childbearing potential must have a negative serum pregnancy test at screening, and a negative urine pregnancy test at randomization (Day 1). Female subjects of childbearing potential must be practicing an effective method of birth control for at least 1 month prior to study entry and throughout the conduct of this trial.
Must have experienced at least 6 partial onset seizures during the prospective baseline.
Must have had no seizure-free interval of more than 4 weeks' duration at any time during the 8-week baseline phase.
Subjects may have complementary evidence for the diagnosis of partial epilepsy, including either imaging procedures or EEG, or both.
Subjects must have provided informed consent.
Subjects with a history (at any time in their life) of Stevens Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, a drug-related exfoliative rash, or any drug related rash requiring hospitalization will not be allowed to enter the open-label extension study EPY-2006. In addition, subjects with a history of rash associated with an AED that involved conjunctiva or mucosae, or a maculopapular rash that required discontinuation of an AED will not be allowed to enter Study EPY-2006.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
History of status epilepticus in the past 3 months.
Subjects who have seizures that cannot be quantitated accurately.
History of any nonepileptic seizures, either currently or in the past.
History of serious systemic disease
History of progressive neurologic disorder.
History of a major psychiatric disorder within the last 2 years.
Current treatment with VNS for less than 12 months, or VNS discontinuation within the past 3 months.
History of a ketogenic diet initiated within the past 3 months.
History of suicidal ideations or suicide attempt within the past 2 years.
History of drug or alcohol abuse within the past 2 years.
History of felbamate treatment within the past 90 days.
Current treatment with vigabatrin, or prior history of treatment with vigabatrin in the absence of reproducible visual field examinations that are deemed to be reliable by an ophthalmologist or neurophthalmologist.
Current treatment with tricyclic antidepressants, such as amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, maprotiline, nortriptyline, protriptyline, or trimipramine.
History of experimental drug or medical device use within 30 days before the planned start of treatment.
Female subjects of childbearing potential who are not using a reliable method of contraception, who are pregnant, or who are breastfeeding.
Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 (100, 300, 800, and 1.600 mg) as adjunctive treatment of refractory partial epilepsy in subjects who are between 18 and 70 years of age, inclusive;Secondary Objective: to evaluate the population pharmacokinetics of RWJ-333369 and to assess the effects of RWJ-333369 on the pharmacokinetics of concomitant AEDs (specifically oxcarbazepine [OXC], phenytoin [PHT], phenobarbital [PB], topiramate [TPM], CBZ, VPA, and LTG). The potential impact of genetic variation on efficacy and safety of RWJ-333369 will also be assessed in subjects who consent to DNA testing.;Primary end point(s): The primary efficacy variable is the percent reduction in seizure frequency (average monthly seizure rate) between the double-blind treatment and the pretreatment baseline, relative to the percent reduction observed for placebo.
- Secondary Outcome Measures
Name Time Method