It is hypothesized that reducing the frequency of dosing may increase subject compliance and
providing the drug in an extended-release formulation may alleviate some of the side effects
observed with Trileptal®.
Inclusion Criteria:
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 eight-week 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-the-counter 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.
Exclusion criteria
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 swallowing SM tablets.
26. Any reason which, in the opinion of the Investigator, would prevent the subject from
participating in the study.
Pazardzhik, Bulgaria; Not yet recruiting
Sofia, Bulgaria; Not yet recruiting
Plovdiv, Bulgaria; Not yet recruiting
Blagoevgrad, Bulgaria; Not yet recruiting
Varna, Bulgaria; Not yet recruiting
Veliko Tarnovo, Bulgaria; Not yet recruiting
Pleven, Bulgaria; Not yet recruiting
Zagreb, Croatia; Not yet recruiting
Rijeka, Croatia; Not yet recruiting
Aguascalientes, Mexico; Not yet recruiting
Konskie, Poland; Not yet recruiting
Krakow, Poland; Not yet recruiting
Warszawa, Poland; Not yet recruiting
Gdansk, Poland; Not yet recruiting
Poznan, Poland; Not yet recruiting
Lodz, Poland; Not yet recruiting
Bialystok, Poland; Not yet recruiting
Szczecin, Poland; Not yet recruiting
Zabrze, Poland; Not yet recruiting
Lipno, Poland; Not yet recruiting
Grodzisk Mazowiecki, Poland; Not yet recruiting
Olsztyn, Poland; Not yet recruiting
Siedlce, Poland; Not yet recruiting
Cluj-Napoca, Romania; Not yet recruiting
Bucharest, Romania; Not yet recruiting
Câmpulung, Romania; Not yet recruiting
Craiova, Romania; Not yet recruiting
Moscow, Russian Federation; Not yet recruiting
Saint-Petersburg, Russian Federation; Not yet recruiting
Novosibirsk, Russian Federation; Not yet recruiting
Smolensk, Russian Federation; Not yet recruiting
Krasnoyarsk, Russian Federation; Not yet recruiting
Ekaterinburg, Russian Federation; Not yet recruiting
Northport, Alabama, United States; Recruiting
Huntsville, Alabama, United States; Recruiting
Birmingham, Alabama, United States; Recruiting
Phoenix, Arizona, United States; Recruiting
Phoenix, Arizona, United States; Not yet recruiting
Tucson, Arizona, United States; Recruiting
Little Rock, Arkansas, United States; Not yet recruiting
Redding, California, United States; Not yet recruiting
Burbank, California, United States; Not yet recruiting
San Jose, California, United States; Not yet recruiting
Oxnard, California, United States; Not yet recruiting
Los Angeles, California, United States; Recruiting
West Los Angeles, California, United States; Not yet recruiting
Santa Monica, California, United States; Not yet recruiting
Fountain Valley, California 92708, United States; Recruiting
Aurora, Colorado, United States; Not yet recruiting
Mexico City, DF, Mexico; Not yet recruiting
Toluca, Estado de Mexico, Mexico; Not yet recruiting
West Palm Beach, Florida, United States; Recruiting
Miami, Florida, United States; Recruiting
Miami, Florida, United States; Not yet recruiting
Jacksonville, Florida, United States; Recruiting
Boca Raton, Florida, United States; Recruiting
Sarasota, Florida, United States; Not yet recruiting
Atlanta, Georgia, United States; Not yet recruiting
Columbus, Georgia, United States; Recruiting
Boise, Idaho, United States; Not yet recruiting
Elkhart, Indiana, United States; Recruiting
Guadalajara, Jalisco, Mexico; Not yet recruiting
Lexington, Kentucky, United States; Recruiting
Baltimore, Maryland, United States; Not yet recruiting
Roseville, Michigan, United States; Not yet recruiting
Detroit, Michigan, United States; Not yet recruiting
Toms River, New Jersey, United States; Recruiting
New York, New York, United States; Not yet recruiting
San Pedro, Nuevo Leon, Mexico; Not yet recruiting
Monterrey, Nuevo Leon, Mexico; Not yet recruiting
Toledo, Ohio, United States; Not yet recruiting
Oklahoma City, Oklahoma, United States; Recruiting
Portland, Oregon, United States; Not yet recruiting
Johnstown, Pennsylvania, United States; Recruiting
Souderton, Pennsylvania 18964, United States; Recruiting
Greenfield Park, Quebec, Canada; Recruiting
Montreal-Est, Quebec, Canada; Not yet recruiting
Rousse, Ruse, Bulgaria; Not yet recruiting
San Luis Potosi, San Luis Potosí, Mexico; Not yet recruiting
St Petersburg, Sestroretsk, Russian Federation; Not yet recruiting
Nashville, Tennessee, United States; Not yet recruiting
Houston, Texas, United States; Not yet recruiting
Galveston, Texas, United States; Not yet recruiting
Baytown, Texas, United States; Recruiting
Richmond, Virginia, United States; Not yet recruiting
