NCT00982787

Safety and Anticonvulsant Efficacy of Passiflora Incarnata Extract in Patients With Partial Epilepsy

A Phase II Randomized, Placebo Controlled, Double-blind, Cross-over Clinical Trial to Test the Safety and Potential Anticonvulsant Efficacy of a Botanical Extract From Passiflora Incarnata, in Patients With Partial Onset Epilepsy.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partial Epilepsy

Interventions

Type	Name	Description
DRUG	Botanical extract from Passiflora incarnata	Dosage form: Liquid Passiflora extract Dosage: 10ml (equivalent of 2.2 g of dried Passiflora) Frequency: Once/Twice a day Duration: 11 week intervention period

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-09-23
• Last updated: 2019-08-13

Locations

1 site across 1 country: United States