Condition or disease | Intervention/treatment | Phase |
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Pediatric Epileptic Syndrome Partial-onset Seizures | Drug: Perampanel Oral Suspension Drug: Perampanel Tablet | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy |
Actual Study Start Date : | May 31, 2019 |
Estimated Primary Completion Date : | October 13, 2021 |
Estimated Study Completion Date : | June 30, 2022 |
Arm | Intervention/treatment |
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Experimental: Perampanel
Participants age 1 month to less than 18 years with pediatric epileptic syndrome (Cohort 1) or age 1 month to less than 2 years with POS with or without secondary generalization (Cohort 2) will receive perampanel oral suspension or perampanel tablets, once daily up to 56 weeks.
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Drug: Perampanel Oral Suspension
Perampanel oral suspension
Other Names:
Drug: Perampanel Tablet Perampanel tablet.
Other Names:
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Ages Eligible for Study: | 1 Month to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eisai Medical Information | +1-888-274-2378 | esi_medinfo@eisai.com |
Tracking Information | |||||
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First Submitted Date ICMJE | May 27, 2019 | ||||
First Posted Date ICMJE | July 10, 2019 | ||||
Last Update Posted Date | April 28, 2021 | ||||
Actual Study Start Date ICMJE | May 31, 2019 | ||||
Estimated Primary Completion Date | October 13, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Proportion of 50% Responders For All Seizures During the Maintenance Period of Core Study [ Time Frame: Week 10 to Week 23 ] A response of 50% will be defined as a decrease in 28-day seizure frequency of equal or greater than 50% compared to baseline seizure frequency.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy | ||||
Official Title ICMJE | An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy | ||||
Brief Summary | The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Perampanel
Participants age 1 month to less than 18 years with pediatric epileptic syndrome (Cohort 1) or age 1 month to less than 2 years with POS with or without secondary generalization (Cohort 2) will receive perampanel oral suspension or perampanel tablets, once daily up to 56 weeks.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
100 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 30, 2022 | ||||
Estimated Primary Completion Date | October 13, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Month to 18 Years (Child, Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Belgium, Czechia, Denmark, France, Germany, Spain, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04015141 | ||||
Other Study ID Numbers ICMJE | E2007-G000-236 2018-004456-38 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Eisai Inc. | ||||
Study Sponsor ICMJE | Eisai Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Eisai Inc. | ||||
Verification Date | March 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |