Perampanel Oral Suspension
DrugPerampanel oral suspension.
Other names: E2007, Fycompa
NCT Number: NCT04015141
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).
This study is active but is not currently recruiting participants.
Notify Me1 month–18 year
All sexes
Interventional
Phase 2
Centre Neurologique William Lennox, Ottignies, Brabant Wallon, Belgium
This study will consist of a Core Study, Extension Phase A and Extension Phase B.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Perampanel oral suspension.
Other names: E2007, Fycompa
Perampanel tablet.
Other names: E2007, Fycompa
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.
Time frame: Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56
A response of 50% is defined as a decrease in 28-day seizure frequency of equal or greater than 50% compared to baseline seizure frequency.
Time frame: Maintenance Period of Core study: Week 10 to Week 23; Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56
A response of 25% is defined as a decrease in 28-day seizure frequency of equal or greater than 25% compared to baseline seizure frequency. 75% response is defined as a decrease in 28-day seizure frequency of equal or greater than 75% compared to baseline seizure frequency.
Time frame: Maintenance Period of Core study: Week 10 to Week 23; Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56
Time frame: Baseline, Treatment Period of Core study: Week 23, Treatment Period of Core Study and Extension Phase A: Week 56
Time frame: Baseline, Treatment Period of Core study: Week 23, Treatment Period of Core Study and Extension Phase A: Week 56
Time frame: Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Assessment of disease severity will utilize the CGIC scale at end of treatment to evaluate participant's change in disease status since initiation of treatment. The CGIC is a 7-point scale that measures a physician's global impression of a participant's clinical condition. Scale ranges from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change.
Time frame: Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
SGIC is a 7-Point scale that provides a participant-determined summary measure of change from baseline of participant's status. Scale ranges from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change.
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
The CDR System Global Cognition Score (cognitive test battery) is derived from 5 CDR System domain scores, also called factor scores: Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory. The CDR assessment and Child Behavior Checklist (CBCL) will be administered to participants 6 years and over and 2 years and over, respectively, using an age-appropriate version to assess cognitive function and behavior.
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
The CBCL is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver. It is standardized to evaluate maladaptive behavioral and emotional problems in ages 1.5 to 5 years (CBCL 1.5/5) or 6 to 18 years (CBCL). The CBCL examines three domains (Social Functioning, Mood and Anxiety Symptoms, and Externalizing Symptoms) by assessing 140 problem items that describe specific behavioral and emotional problems. Respondents indicate how accurately the statements describe the child by selecting from options on a 3-point Likert-type scale (0=Not True, 1= Somewhat or Sometimes True, or 2=Very True or Often True).
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
LGPT measures visuomotor skills. This test is a manipulative dexterity test that consist of a metal matrix of 25 holes with randomly positioned slots. Participants require to insert 10 grooved pegs into the holes. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task is timed and the scores are the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds are recorded for the time. An increase in score (longer time) indicates worsening of visuomotor skills.
Time frame: Baseline, Treatment Period of Core Study: Week 23; Extension Phase A: Weeks 28, 40, and 56
Time frame: Baseline, Treatment Period of Core Study: Weeks 2, 5, 8, 10, 14, 18 and 23; Extension Phase A: Weeks 28, 40, 56, and 60
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Time frame: Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56
Sexual maturation including pubic hair growth (both sexes), genital (males only) and breast (females only) development of participants will be assessed using Tanner Staging.
Time frame: Treatment period of Core Study: Weeks 0, 2, 5, 8, 10, 14, 18, and 23; Extension Phase A: Weeks 28, 46, 56 and 60
C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS is used to assess whether participant experienced SI (1:wish to be dead; 2:non-specific active suicidal thoughts; 3:active SI with any methods (not plan) without intent to act; 4:active SI with some intent to act, without specific plan; 5:active SI with specific plan and intent) and suicidal behavior (6:actual attempt; 7:interrupted attempt; 8:aborted attempt; 9:preparatory acts or behavior; 10:suicidal behavior). An assessment of SI and behavior using the C-SSRS will be performed throughout the study for participants aged 6 years and above at the time of consent. In participants younger than 6 years, SI and behavior will be monitored based upon clinical impression.
Time frame: Baseline, End of the Treatment Period of Core Study: Week 23, End of Extension Phase A: Week 56
Time frame: From date of first dose of perampanel up to 28 days after the last dose of perampanel (Week 60)
Time frame: From date of first dose of perampanel up to Week 60
Time frame: From date of first dose of perampanel up to 28 days after the last dose of perampanel (Week 60)
Vital sign measurements include systolic and diastolic blood pressure [millimeters of Mercury (mmHg)], pulse (beats per minute), respiratory rate (per minute), temperature (degree centigrade), and weight (kilogram).
Time frame: From date of first dose of perampanel up to Week 60
Eisai Inc.
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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