Multicenter, Double-Blind, Randomized, Placebo-Controlled, Three-Arm,Parallel Group Study to Evaluate the Efficacy and Safety of OxcarbazepineExtended-Release (OXC XR) (1200 and 2400mg/day) as AdjunctiveTherapy in Subjects with Refractory Partial Seizures due to Epilepsy on upto Three Concomitant Antiepileptic Medications - PROSPER
- Conditions
- Treatment of seizures of partial origin in subjects with refractory epilepsyMedDRA version: 9.1Level: LLTClassification code 10015037Term: Epilepsy
- Registration Number
- EUCTR2008-003333-25-BG
- Lead Sponsor
- Supernus Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
1) Capable of complying with the study procedures.
2) Able to provide written informed consent prior to any study procedure being conducted.
3) Male or female aged 18 to 65 years, inclusive.
4) Current diagnosis of partial onset seizures with or without secondarily generalized seizures as
confirmed by the 1981 and 1989 International League Against Epilepsy [ILAE] Classifications.
5) Experiencing at least three countable partial seizures per 28 days on average during the eightweek
Baseline Phase, or during the four-week Baseline plus the four-week period prior to
Baseline, assuming the recording method is considered acceptable. Simple partial seizures in the
Baseline Phase must have had an observable motor component.
6) Currently receiving treatment with at least one and up to three AEDs with AED therapy remaining
at a stable dose for at least four weeks prior to Baseline (equivalent to 12 weeks prior to
randomization). A vagal nerve stimulator (VNS) will be allowed, but will not be considered as one
of the concomitant AEDs for the purpose of inclusion into the study. The VNS must have been
implanted for at least six months prior to randomization. Stimulator parameters may not be
changed for at least one month prior to screening (equivalent to 12 weeks prior to randomization)
or during the study. Note, magnet use will be allowed, but must be documented throughout the
study.
7) History of being refractory on at least one and up to three AEDs in single or combination use.
8) Magnetic resonance imaging (MRI), with or without contrast, or computerized tomography (CT),
within the past 5 years showing no progressive neurological conditions. For subjects with MRI or
CT older than 5 years, the MRI or CT can be performed in screening.
9) Use of prescription medications, except those specifically prohibited by protocol, and over-thecounter
products, including natural food supplements, vitamins, garlic as a supplement, will be
permitted as long as a stable dose has been maintained for four weeks prior to receiving study
medication (SM).
10) Weight = 41kg.
11) Sexually active women, unless surgically sterile (at least 6 months prior to SM administration) or
at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including
oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a
secondary method], intrauterine device, female condom with spermicide, diaphragm with
spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile
[at least 6 months prior to SM administration] sexual partner) for at least four weeks prior to SM
administration, and must agree to continue using such precautions through the End of Study visit.
Cessation of birth control after this point should be discussed with a responsible physician.
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) no
F.1.3.1 Number of subjects for this age range
1) History of being refractory to OXC for reasons of efficacy based on 1200mg/day dose and
2-month trial period.
2) A documented history of generalized status epilepticus within the past 2 years.
3) A documented history of non-epileptic seizures in the past 2 years.
4) Seizures secondary to illicit drug or alcohol use, infection, neoplasia, demyelinating disease,
degenerative neurological disease, or central nervous system disease deemed progressive,
metabolic illness, or progressive degenerative disease.
5) Diagnosis or an encephalogram consistent with a diagnosis of seizure disorders other than partial
epilepsy.
6) Meets criteria for current major depressive episode, according to Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition Text Revision, within 6 months prior to
Screening (Visit 1).
7) Current use of antidepressants. However, those subjects who are only taking a stable dose of
either a selective serotonin reuptake inhibitor (SSRI) antidepressant drug or a serotonin and
norepinephrine reuptake inhibitor (SNRI) antidepressant drug for a diagnosed depressive disorder
can be included as long as they have been on the SSRI or SNRI for a period of at least 56 days
prior to randomization. Other antidepressant medications will not be allowed.
8) Active suicidal plan/intent or active suicidal thoughts in the past 6 month.
9) Suicide attempt within the last 2 years;
10) More than one lifetime suicide attempt.
11) History or presence of clinically significant, chronic medical condition, including hyponatremia,
especially those contraindicating antiseizure medication (e.g., any neurological, gastrointestinal,
endocrine, cardiovascular, pulmonary, hematological, immunologic, renal, hepatic, or metabolic
disease) that may affect the safety of the subject in the opinion of the Investigator.
12) Current use of oxcarbazepine.
13) Phenytoin use is allowed if the subject is on a stable dose and the results of two consecutive
serum phenytoin levels are <15 mcg/mL. One of the two levels must be drawn at screening.
14) Use of felbamate with less than 18 months of continuous exposure prior to screening.
15) Frequent need of rescue benzodiazepines (more than once in a 7 day period).
16) Current use of diuretics or other sodium (Na+) lowering non-anti-epileptic medications.
17) History or presence of clinically significant laboratory, electrocardiogram (ECG), or vital sign
(systolic blood pressure [SBP] <90 or >140 millimeters of mercury [mmHg], diastolic blood
pressure [DBP] <40 or >90mmHg, or heart rate [HR] <40 or >100 beats per minute [BPM])
abnormalities at screening that may affect the safety of the subject, in the opinion of the
Investigator.
18) Presence of potential hepatic function impairment as shown by, but not limited to alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) values >3 times upper limit of
normal (ULN), or total bilirubin >1.5 ULN.
19) Presence of suspected impairment of renal function defined by serum creatinine =1.5 times ULN.
20) History of alcohol abuse within two years prior to the screening.
21) History of substance abuse or dependence within two years prior to screening.
22) Females who are pregnant or lactating.
23) Previous known hypersensitivity to OXC or other related drugs, such as carbamazepine, or any of
the product components.
24) Use of an investigational drug or device, or participation in an investigational study within 30 days
prior to the first dose of SM.
25) Difficulty s
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