Partial EpilepsyPhase 2NCT00982787
Safety and Anticonvulsant Efficacy of Passiflora Incarnata Extract in Patients With Partial Epilepsy
A Phase 2 study testing Botanical extract from Passiflora incarnata in people with Partial Epilepsy, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Partial Epilepsy
- What is being tested?
- Botanical extract from Passiflora incarnata
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science Universtiy
Portland, Oregon, 97239
About this study
Official title: 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.
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
- Being tested
- Botanical extract from Passiflora incarnata
- Keywords
- Epilepsy, Seizures, Passiflora
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botanical extract from Passiflora incarnataDrug
Also called Whole ethanolic extract from Passiflora Incarnata dried herb
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Botanical extract from Passiflora incarnata |
| 2 | Placebo comparator | Not described Receives: Drug: Botanical extract from Passiflora incarnata |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
Measured: 32 weeks
Secondary outcomes (2)
Anxiety, sedation, quality of life
Measured: 32 weeks
Cognitive testing
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial EpilepsyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Oregon Clinical and Translational Research Institute, Oregon's Wild Harvest
- Responsible party
- Sponsor
- Investigators
- Siegward M Elsas, M.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982787
- Sponsor's protocol ID
- 3107
- Other IDs
- 5K23AT001933-03
- Status last verified
- Aug 2019
- First submitted
- 22 Sep 2009
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00982787
- Acronym / sponsor ID
- 3107
- Conditions
- Partial Epilepsy
- Keywords
- Epilepsy, Seizures, Passiflora
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Oregon Clinical and Translational Research Institute, Oregon's Wild Harvest
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Botanical extract from Passiflora incarnata |
| 2 | Placebo comparator | Drug: Botanical extract from Passiflora incarnata |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botanical extract from Passiflora incarnataAlso: Whole ethanolic extract from Passiflora Incarnata dried herbDosage form: Liquid Passiflora extract Dosage: 10ml (equivalent of 2.2 g of dried Passiflora) Frequency: Once/Twice a day Duration: 11 week intervention period | Drug | 1, 2 |
Primary outcome
Seizure frequency
Time frame: 32 weeks
2 secondary outcomes
Anxiety, sedation, quality of life
Time frame: 32 weeks
Cognitive testing
Time frame: 32 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siegward M Elsas, M.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botanical extract from Passiflora incarnata in people with Partial Epilepsy, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.