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Clinical trialNCT00982787WithdrawnPhase 2Interventional

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

SponsorOregon Health and Science UniversityEnrollment0Partial Epilepsy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Oregon Health and Science Universtiy

    Portland, Oregon, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Botanical extract from Passiflora incarnata
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2009
Primary completion
31 Jan 2011
Completion
31 Jan 2011
Last update posted
13 Aug 2019
Registered enrollment
0
Registry id
NCT00982787

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.