Safety and Anticonvulsant Efficacy of Passiflora Incarnata Extract in Patients With Partial Epilepsy
Primary Purpose
Partial Epilepsy
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botanical extract from Passiflora incarnata
Sponsored by
About this trial
This is an interventional treatment trial for Partial Epilepsy focused on measuring Epilepsy, Seizures, Passiflora
Eligibility Criteria
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.
Sites / Locations
- Oregon Health and Science Universtiy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Seizure frequency
Secondary Outcome Measures
Anxiety, sedation, quality of life
Cognitive testing
Full Information
NCT ID
NCT00982787
First Posted
September 22, 2009
Last Updated
August 9, 2019
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
1. Study Identification
Unique Protocol Identification Number
NCT00982787
Brief Title
Safety and Anticonvulsant Efficacy of Passiflora Incarnata Extract in Patients With Partial Epilepsy
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy
Keywords
Epilepsy, Seizures, Passiflora
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Botanical extract from Passiflora incarnata
Other Intervention Name(s)
Whole ethanolic extract from Passiflora Incarnata dried herb
Intervention Description
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
Primary Outcome Measure Information:
Title
Seizure frequency
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Anxiety, sedation, quality of life
Time Frame
32 weeks
Title
Cognitive testing
Time Frame
32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siegward M Elsas, M.D.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science Universtiy
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Anticonvulsant Efficacy of Passiflora Incarnata Extract in Patients With Partial Epilepsy
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