Safety and Anticonvulsant Efficacy of Passiflora Incarnata Extract in Patients With Partial Epilepsy
Status:
Withdrawn
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Oregon Health and Science University
Collaborators:
National Center for Complementary and Integrative Health (NCCIH) Oregon Clinical and Translational Research Institute Oregon's Wild Harvest