| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
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.
|
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 |
Show 46 study locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| 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 | ||||
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* 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 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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