Safety and Anticonvulsant Efficacy of Passiflora Incarnata Extract in Patients With Partial Epilepsy
Safety and Anticonvulsant Efficacy of Passiflora Incarnata Extract in Patients With Partial Epilepsy
The purpose of the Phase II clinical trial will be to see if a botanical extract from the
 plant Passiflora incarnata can improve seizure control and reduce anxiety in patients
 diagnosed with partial epilepsy.

 The investigators will randomize approximately 25 participants with partial epilepsy for this
 placebo controlled, double blind, and crossover study. All patients will be scheduled for 10
 clinic visits and four telephone visits during the 32-week period of the trial. After
 enrollment into the study, all participants will begin a 9-week observation phase, which
 serves as an individual baseline control. After 9 weeks participants will be randomized to
 receive either study drug or placebo for an 11 week study period. After completion of the 11
 week study period, patients will crossover to the other study drug/placebo arm for another 11
 weeks. Epilepsy participants will continue taking their anti-epileptic medication as
 currently prescribed. The investigators will find participants through the OHSU clinics, by
 notifying local neurologists, anthroposophical and naturopathic practices, and by advertising
 the study via the local chapter of the American Epilepsy Society.

 Routine blood tests, physical examinations and tests to monitor heart, brain and muscle
 activities will screen for any adverse effects. The primary outcome measure will be seizure
 frequency through seizure diaries. Attention and performance tests, neurological and quality
 of life questionnaires will be completed to assess the secondary outcome measures of anxiety,
 cognitive function and quality of life.
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.