A Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Retention Rate, Efficacy, Safety, and Tolerability of Carisbamate, Topiramate and Levetiracetam as Adjunctive Therapy in Subjects with Partial Onset Seizures - CaReS (Carisbamate Retention Study)
- Conditions
- Partial onset seizuresMedDRA version: 9.1Level: LLTClassification code 10034091Term: Partial seizures, simple
- Registration Number
- EUCTR2007-002929-78-FI
- Lead Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1. Male or female aged 16 years or older
2. Subjects must weigh at least 45 kg (~100lbs)
3. Established diagnosis, for at least 3 months prior to screening, of epilepsy characterized by partial onset seizures, including simple partial motor, complex partial, or secondarily generalized seizures
4. At least 1 partial onset seizure but no more than 120 partial onset seizures during the 3-month retrospective baseline period prior to screening
5. History of monotherapy AED failure (due to lack of efficacy or tolerability) to at least 1 but not more than 4 AEDs in the past. The occasional use of rescue medication is not considered prior AED use
6. Current AED treatment with at least 1 and no more than 2 AEDs given at stable dosage(s) 30 days prior to screening. Additional infrequent (less than 3 days during the 3 month baseline) and occasional use of sedatives or benzodiazepines to prevent breakthrough seizures is permitted
7. Females must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, practicing an acceptable method of birth control (eg, intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study. Females must have a negative serum beta chorionic gonadotropin pregnancy test result at screening/randomization
8. Negative urine drug screen (except for prescription benzodiazepines, prescription barbiturates, or prescription narcotics) at screening
9. Willing to adhere to the prohibitions and restrictions as specified in Section 4.4, Prohibitions and Restrictions
10. Must have signed an informed consent form document (subjects or their legally acceptable representatives) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of adolescents as described in Section 16.2.3, Informed Consent. (Assent applies to adolescents only. Adults not competent to consent will not be allowed into the study.)
11. For adolescents (as defined by local regulations), a responsible person must be available to accompany the subject to the study center at each visit, to provide reliable information for the safety and efficacy evaluations, and to accurately and reliably dispense the study drug as directed, if in the opinion of the investigator, the subject cannot otherwise be compliant with study procedures and study drug
Are the trial subjects under 18? yes
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
1. Have a generalized epileptic syndrome
2. Have primary generalized seizures
3. Have atonic seizures
4. Have typical or atypical absence seizures
5. Have only simple partial type seizures with manifestations other than motor symptoms (ie, simple partial sensory)
6. History of unprovoked status epilepticus in the last 6 months prior to screening
7. History of Lennox-Gastaut Syndrome
8. Any previous and/or current treatment with TPM or LEV (or other medications with equivalent international non-proprietary names)
9. More than 3 days of sedative or benzodiazepine use for seizures in the 3 months prior to screening
10. Diagnosis of psychotic disorder, bipolar disease, or major depression or other neurologic conditions, serious or medically unstable systemic disease, suicidal ideation or attempts, or homicide attempts at any time in the past 2 years
11. History of nephrolithiasis with symptomatic renal stones within the last 2 years prior to screening
12. Diagnosis of autism and/or pervasive developmental disability not otherwise specified (NOS) and/or mental retardation or evidence of an intelligence quotient (IQ) =70
13. ALT greater than 1.5 times the ULN or total bilirubin above the ULN at screening
14. History of drug-induced liver injury (ie, history of ALT elevation 3 times ULN from prior drug exposure) or severe drug-induced, hypersensitivity reactions
15. History of any medical conditions that could potentially disqualify the subject for medical or safety reasons (e.g., renal insufficiency; vascular, pulmonary, gastrointestinal, endocrine, hematologic, or metabolic disturbances)
16. Diagnosis of any form of chronic liver disease, cirrhosis, or liver cancer. Examples of chronic liver disease include autoimmune hepatitis, hemochromatosis, Wilson’s disease, primary biliary cirrhosis, sclerosing cholangitis
17. Positive hepatitis serology as determined by multiantigen enzyme immunoassay (EIA): includes Anti-HCV, HBsAg, Anti-HBc, HepBCoreM, and Anti-HBs. Subjects with positive Anti-HCV test results will be excluded from the study. Criteria for excluding subjects based on hepatitis B results are provided in Attachment 1
18. Known to be positive for human immunodeficiency virus/ acquired immunodeficiency syndrome (HIV/AIDS). Note: HIV testing is not required for this study
19. Clinically relevant abnormalities for laboratory test values at screening
20. History of experimental drug or medical device use within the 30 days prior to screening
21. History of prior participation in a clinical trial of CRS or any prior exposure to CRS
22. Current treatment with a vagal nerve stimulator (VNS) or ketogenic diet
23. Planned epilepsy surgery within the next 12 months
24. Subjects with clinical evidence of significant cardiac disease, including unstable angina, myocardial infarction within the past 2 years, uncontrolled heart failure, congenital short QT syndrome, Brugada syndrome, major arrhythmias, or significant shortening or lengthening of QTcF intervals (<330 ms or >500 ms) should be excluded from the study
25. Females who are pregnant or breast-feeding
26. Unable to meet or perform study requirements (eg, recording of subject diary information), inability to read and comprehend instructions or to use a computer and its peripherals (mouse, keyboard), known or suspected inability to comply with the study protocol
27. Unable to swallow solid oral dosage forms whole with the aid of water (subjects may not chew, divide, dissolve, or crush the stud
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method