| Last Verified: | July/31/2019 |
| First Submitted: | September/21/2009 |
| Estimated Enrollment Submitted: | September/21/2009 |
| First Posted: | September/22/2009 |
| Last Update Submitted: | August/8/2019 |
| Last Update Posted: | August/12/2019 |
| Actual Study Start Date: | August/31/2009 |
| Estimated Primary Completion Date: | December/31/2010 |
| Estimated Study Completion Date: | December/31/2010 |
| Study Type: | Interventional |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 | |
| Placebo Comparator: 2 |
| Ages Eligible for Study: | 18 Years to 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Criteria: | Inclusion Criteria: - Age 18-70 years old. - Reliable history of seizure semiology, EEG or EEG video telemetry confirming the diagnosis of partial epilepsy. - Seizure frequency of at least 6 complex partial seizures over the 9 weeks prior to enrollment, with no 3 week period with less than one seizure, in spite of adequate treatment with a stable anticonvulsant dosage with one or two anticonvulsants for at least one month. Every seizure in a cluster will count as a separate seizure. - Willing to maintain current anticonvulsant dosage for 32 weeks. Tapering off a third anticonvulsant up to one month prior to enrollment to allow study participation is permitted. Consent will be obtained prior to tapering of a third anticonvulsant. Habitual use of an additional rescue medication such as lorazepam for excess seizure activity is permitted but not more frequently than once every three weeks. - Women of childbearing potential need to have a negative urine pregnancy test and practice two simultaneous methods of birth control, which may not include oral contraceptives. Due to drug interactions, oral contraceptives are not considered a safe method of birth control in patients using anticonvulsant medications. Women who are at least two years post-menopausal will be exempt from the pregnancy test or birth control requirements. Exclusion criteria: - Unreliable history of seizure semiology. - Seizure frequency less than six complex partial seizures over 9 weeks or no seizure in any 3-week period in the 9 weeks prior to enrollment. - Patients in whom it is anticipated that current standard of care would mandate a change in their conventional epilepsy treatment during the time period of the study will be excluded. - Patients with a widely fluctuating seizure frequency (good months and bad months) or a history of status epilepsy will be excluded. - Women who are currently pregnant or lactating - Patients with other serious medical problems, such as brain tumors, cancer, stroke, significant heart disease or psychiatric disorders such as schizophrenia or major depression will be excluded. - Patients with progressive epilepsy syndromes, neurodegenerative disorders or dementia will be excluded. - Patients with impaired renal or hepatic function as detected by abnormal BUN or AST/ALT/alk phos on initial screening will be excluded. - Patients at increased risk for ventricular arrhythmias (history of heart failure, prolonged QTc > 450 ms, family history of prolonged QT syndrome, hypokalemia, or those using any diuretics or drugs which prolong the QT, see http://www.azcert.org) will be excluded. - Patients with a high likelihood of psychogenic or non-epileptic seizures will be excluded by the following method previously developed at the Oregon Health and Science University (OHSU) epilepsy program. - Patients who use alcohol, drugs or have participated in another clinical trial in the past 6 months, and patients who are found to be less than 80% compliant with their documentation of seizure and medication diary will be excluded as will patients unwilling to stop using oral contraceptives at the time of study enrollment. Patients who agree to participate and are currently taking botanicals will be asked to discontinue them at enrollment, as these may confound study results or cause safety issues. - Patients who are found to have generalized spike and wave discharges, diagnostic of primary generalized epilepsy, on their EEG will be excluded from the study. |