Last updated on February 2018

Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures


Brief description of study

This is an open-label, multicenter study with an extension phase to evaluate the safety and tolerability of an perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to <12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic seizures (PGTC).

Detailed Study Description

This is a multicenter, open-label, single-arm study in children (ages 4 to less than 12 years) with inadequately controlled POS or PGTC. The study will consist of a Core Study and two Extension Phases (Extension A and Extension B). The Core Study will consist of the following 2 phases: Pretreatment and Treatment Phase. The Pretreatment Phase, during which participants will be assessed for eligibility, will consist of up to a 4-week 3 day Screening/Baseline Period. The Treatment Phase will consist of 3 periods: up to an 11-week Titration Period (dose titration on the basis of individual clinical response and tolerability), up to a 12-week Maintenance Period (continuation of perampanel oral suspension once daily at the dose level achieved at the end of the Titration Period), and up to a 4-week Follow-up Period (only for those participants not rolling over into Extension A). Extension A will consist of up to a 29-week Maintenance Period and up to a 4-week Follow-up Period. Visit 10 will be completed within 5 weeks 6 days of Visit 9. All participants who complete all scheduled visits up to and including Visit 9 in the Treatment Phase will be eligible to participate in Extension A of the study. During the Maintenance Period of Extension A, all participants will continue with their optimal perampanel dose (i.e., dose level that they completed on during the Core Study). Participants who do not continue in Extension A or those who prematurely discontinue from the study will enter up to a 4-week Follow-up Period. Participants in Japan, who complete Extension A, may be eligible to participate in Extension B. Extension B will consist of a Treatment Phase which will continue as long as clinically appropriate according to the judgment of the investigator. Treatment of participants in Extension B will be completed when the participant reaches 12 years of age or when perampanel is commercially available in Japan for treatment of POS in pediatric participants (4 to <12 years of age).

Clinical Study Identifier: NCT02849626

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Little Rock, AR United States
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Palo Alto, CA United States
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New Haven, CT United States
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Loxahatchee Groves, FL United States
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Atlanta, GA United States
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Lexington, KY United States
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Lexington, KY United States
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New Orleans, LA United States
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Shreveport, LA United States
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Brooklyn, NY United States
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Winston-Salem, NC United States
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Akron, OH United States
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Cincinnati, OH United States
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Cleveland, OH United States
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Memphis, TN United States
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Austin, TX United States
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San Antonio, TX United States
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Tacoma, WA United States
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Wauwatosa, WI United States
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Pulderbos, Belgium
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Ottignies, Belgium
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Bruxelles, Belgium
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La Louviere, Belgium
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Brussels, Belgium
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Marseille, France
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Lille Cedex, France
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Paris, France
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Paris, France
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Strasbourg, France
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Toulouse Cedex 9, France
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Budapest, Hungary
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Budapest, Hungary
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Miskolc, Hungary
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Pecs, Hungary
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Mantova, Italy
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Calambrone, Italy
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Firenze, Italy
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Milano, Italy
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Sapporo, Japan
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Zentsuji, Japan
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Sendai-shi, Japan
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Hamamatsu, Japan
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Fukuoka-shi, Japan
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Fukuoka, Japan
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Osaka, Japan
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Shizuoka, Japan
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Yamagata, Japan
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Yokohama-shi, Japan
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Daegu, Korea, Republic of
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Daejeon, Korea, Republic of
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Seoul, Korea, Republic of
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Seoul, Korea, Republic of
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Seoul, Korea, Republic of
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Riga, Latvia
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