A Study to Evaluate the Pharmacodynamic Activity of E2082 in Adult Participants With Photosensitive Epilepsy
NCT ID: NCT03686033
Last Updated: 2020-09-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2018-10-31
2019-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo, E2082 2.5 mg, E2082 25 mg, E2082 40 mg
Participants will receive a single dose of E2082-matched placebo tablet orally (Treatment A) in Treatment Period 1 followed by a single dose of E2082 tablets at 2.5 mg orally (Treatment B) in Treatment Period 2 followed by a single dose of E2082 tablets at 25 mg orally (Treatment C) in Treatment Period 3 followed by a single dose of E2082 tablets at 40 mg orally in Treatment Period 4. A wash-out phase of at least 2 weeks will be maintained between all the treatment periods.
Placebo
Participants will receive E2082-matched placebo tablets orally.
E2082
Participants will receive E2082 tablets orally.
E2082 2.5 mg, E2082 25 mg, Placebo, E2082 40 mg
Participants will receive a single dose of E2082 tablets at 2.5 mg orally (Treatment B) in Treatment Period 1 followed by a single dose of E2082 tablets at 25 mg orally (Treatment C) in Treatment Period 2 followed by a single dose of E2082-matched placebo tablet orally (Treatment A) in Treatment Period 3 followed by a single dose of E2082 tablets at 40 mg orally in Treatment Period 4. A wash-out phase of at least 2 weeks will be maintained between the treatment periods.
Placebo
Participants will receive E2082-matched placebo tablets orally.
E2082
Participants will receive E2082 tablets orally.
E2082 25 mg, Placebo, E2082 2.5 mg, E2082 40 mg
Participants will receive a single dose of E2082 tablets at 25 mg orally (Treatment C) in Treatment Period 1 followed by a single dose of E2082-matched placebo tablet orally (Treatment A) in Treatment Period 2 followed by a single dose of E2082 tablets at 2.5 mg orally (Treatment B) in Treatment Period 3 followed by a single dose of E2082 tablets at 40 mg orally in Treatment Period 4. A wash-out phase of at least 2 weeks will be maintained between the treatment periods.
Placebo
Participants will receive E2082-matched placebo tablets orally.
E2082
Participants will receive E2082 tablets orally.
Placebo, E2082 25 mg, E2082 2.5 mg, E2082 40 mg
Participants will receive a single dose of E2082-matched placebo tablet orally (Treatment A) in Treatment Period 1 followed by a single dose of E2082 tablets at 25 mg orally (Treatment C) in Treatment Period 2 followed by a single dose of E2082 tablets at 2.5 mg orally (Treatment B) in Treatment Period 3 followed by a single dose of E2082 tablets at 40 mg orally in Treatment Period 4. A wash-out phase of at least 2 weeks will be maintained between the treatment periods.
Placebo
Participants will receive E2082-matched placebo tablets orally.
E2082
Participants will receive E2082 tablets orally.
E2082 2.5 mg, Placebo, E2082 25 mg, E2082 40 mg
Participants will receive a single dose of E2082 tablets at 2.5 mg orally (Treatment B) in Treatment Period 1 followed by a single dose of E2082-matched placebo tablet orally (Treatment A) in Treatment Period 2 followed by a single dose of E2082 tablets at 25 mg orally (Treatment C) in Treatment Period 3 followed by a single dose of E2082 tablets at 40 mg orally in Treatment Period 4. A wash-out phase of at least 2 weeks will be maintained between the treatment periods.
Placebo
Participants will receive E2082-matched placebo tablets orally.
E2082
Participants will receive E2082 tablets orally.
E2082 25 mg, E2082 2.5 mg, Placebo, E2082 40 mg
Participants will receive a single dose of E2082 tablets at 25 mg orally (Treatment C) in Treatment Period 1 followed by a single dose of E2082 tablets at 2.5 mg orally (Treatment B) in Treatment Period 2 followed by a single dose of E2082-matched placebo tablet orally (Treatment A) in Treatment Period 3 followed by a single dose of E2082 tablets at 40 mg orally in Treatment Period 4. A wash-out phase of at least 2 weeks will be maintained between the treatment periods.
Placebo
Participants will receive E2082-matched placebo tablets orally.
E2082
Participants will receive E2082 tablets orally.
Interventions
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Placebo
Participants will receive E2082-matched placebo tablets orally.
E2082
Participants will receive E2082 tablets orally.
Eligibility Criteria
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Exclusion Criteria
2. Male participants who have not had a successful vasectomy, they and their female partners not of childbearing potential, or practicing highly effective contraception throughout the study period and for 28 days after study drug discontinuation. No sperm donation is allowed during the study period and for 28 days after study drug discontinuation.
3. History of nonepileptic seizures (example, metabolic, structural, or pseudoseizures) while on any antiepileptic medication.
4. History of status epilepticus while on any antiepileptic medication(s) within 2 years before screening.
5. Ongoing or history of generalized tonic-clonic seizures (GTCS) within 6 months before screening.
6. Participants who had developed a clinical seizure during previous PPR assessment, or who experiences a clinical seizure during the Screening IPS procedure.
7. Frequent spontaneous background burst or current evidence of proconvulsive activity on EEG (example, increase in spike-wave activity) at screening.
8. Inability to follow restriction on watching television, or use of any device(s) with an animated screen (example, computer, video games, tablets, or smart phone) from the time of arrival at the study center until study procedures are completed for that day.
9. Use of perampanel within 6 weeks before screening.
10. Use of felbamate for less than 2 years or where the dose has not been stable for at least 8 weeks before Visit 1.
11. Use of vigabatrin within 5 months before screening and/or documented evidence of vigabatrin associated clinically significant abnormality in a visual perimetry test.
12. Use of benzodiazepines for non-epilepsy related indications. Intermittent use of benzodiazepines as rescue medication or stable dosage (greater than 4 weeks before screening) for epilepsy indications is allowed.
13. Concomitant use of cannabinoids.
14. Use of concomitant potent cytochrome P450 (CYP)3A inducers or inhibitors within 4 weeks or 5 half-lives, whichever is longer.
15. Vagus nerve stimulation (VNS) implanted within 5 months or changes in parameter within 4 weeks before screening.
16. On a ketogenic diet for which the diet is not a stable regimen for at least 4 weeks before screening.
17. Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
18. A history of prolonged QT syndrome or risk factors for torsade de pointes, or the use of concomitant medications that cause QT prolongation as demonstrated on screening electrocardiogram (ECG).
19. Any suicidal ideation with intent with or without a plan within 6 months before or during screening, and/or any lifetime suicidal behavior.
20. Any psychotic disorder(s) or unstable recurrent affective disorders.
18 Years
60 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trials, Inc. and Arkansas Epilepsy Program
Little Rock, Arkansas, United States
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, United States
Johns Hopkins University- School of Medicine
Baltimore, Maryland, United States
Washington University Hospital
St Louis, Missouri, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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E2082-A001-201
Identifier Type: -
Identifier Source: org_study_id
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