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perampanel for Epilepsy

Phase 2
Waitlist Available
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have had 1 or more seizure(s) before Visit 1
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up maintenance period of the core phase- days 127 and 141: 1-5 hours post-dose (cohort 1, cohort 2, cohort 3); days 127 and 141: pre-dose, 1-5 hours post-dose (cohort 4)
Awards & highlights

Study Summary

This trial is testing a suspension form of perampanel, given as adjunctive therapy to kids 1mo-4yrs old with epilepsy, to see how well it is tolerated and absorbed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have experienced at least one seizure before your first visit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~maintenance period of the core phase- days 127 and 141: 1-5 hours post-dose (cohort 1, cohort 2, cohort 3); days 127 and 141: pre-dose, 1-5 hours post-dose (cohort 4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and maintenance period of the core phase- days 127 and 141: 1-5 hours post-dose (cohort 1, cohort 2, cohort 3); days 127 and 141: pre-dose, 1-5 hours post-dose (cohort 4) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Normalized AUCtau,ss of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants
Dose Normalized Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants
Dose Normalized Average Steady-state Drug Concentration (Css,Av) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants
+5 more
Secondary outcome measures
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameter: Bilirubin
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase
Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Albumin, Globulin, Protein
+18 more

Side effects data

From 2010 Phase 3 trial • 712 Patients • NCT00700310
12%
Somnolence
10%
Dizziness
9%
Headache
6%
Upper respiratory tract infection
4%
Nasopharyngitis
4%
Fatigue
1%
Confusional state
1%
Ankle fracture
1%
Delirium
1%
Gait disturbance
1%
Goitre
1%
Aggression
1%
Nephrolithiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Perampanel 2mg
Perampanel 4mg
Perampanel 8 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Perampanel up to 12 or 16 mg/dayExperimental Treatment1 Intervention
Pediatric participants, ranging from 1 month to less than 4 years of age, will receive perampanel oral suspension once a day in titration period starting at Week 0 at a dose of 0.50 mg per day (mg/day) titrated up to 4 mg/day (for participants taking non-EIAED) or up to 8 mg/day (for participants taking EIAED). Depending on participants clinical response, tolerability and investigator's decision, dose can be up titrated to 6 mg/day (for participants taking non-EIAED) and up titrated to 8 mg/day (for participants taking EIAED). Dose titration must not exceed 12 mg/day (non-EIAED) and 16 mg/day (EIAED). Participants will continue taking the perampanel oral suspension at dose level achieved at end of titration period through maintenance period of core study and maintenance period of extension phase (Up to Week 52).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
perampanel
2008
Completed Phase 3
~2120

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
153,994 Total Patients Enrolled
29 Trials studying Epilepsy
6,568 Patients Enrolled for Epilepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruiting process still ongoing for this trial?

"Unfortunately, this research study is not taking on new participants at the moment. It was initially advertised in February 2017 and its details were last updated in September 2022. Fortunately, there are 239 trials accepting patients with aura and 11 clinical studies recruiting for perampanel treatments right now."

Answered by AI

Could you elucidate on any additional clinical studies centered around perampanel?

"Perampanel was initially evaluated by Stony Brook University Medical Center in 2017, leading to a total of 52 finished trials. Currently, 11 more are actively recruiting patients, with many being held out of Durham, North carolina."

Answered by AI

To what extent is this study accommodating participants?

"As of the time of writing, this research endeavour is not seeking new individuals for their trial. It was first posted on February 20th 2017 and most recently updated on September 2nd 2022. For those who are interested in similar studies, there are 239 trials recruiting patients with aura and 11 clinical trials searching for participants taking perampanel."

Answered by AI

How many geographical locations is this research taking place in?

"Currently, this trial is seeking patients from 14 clinics distributed across Durham, New Brunswick and Atlanta as well other towns. To reduce travel costs, it would be prudent to select the clinic closest you if participating."

Answered by AI

To whom is participation in this clinical experiment accessible?

"This clinical trial necessitates the recruitment of 50 individuals, aged from 1 Month to 4 Years old, that can demonstrate an aura. Moreover, participants must also meet other qualifications such as having a diagnosis for epilepsy according to ILAE's Classification of Epileptic Seizures (1981), being administered between 1 and 4 antiepileptic drugs within 2 weeks before the first visit with constant doses over 5 half-lives or more prior to said visit, weighing at least 8.8 pounds (4 kilograms) upon consenting for inclusion in the study, and potentially completing all maintenance visits if they decide to enter into its Extension Phase"

Answered by AI

Is the age limit of this experiment greater than 30 years of age?

"The information found in the study's requirements states that children between 1 month and 4 years old are eligible for this medical trial."

Answered by AI

Are there any regulatory approvals for perampanel?

"Perampanel's safety was given a rating of 2 since this is a Phase 2 clinical trial, thus indicating that there is some evidence to support its security but none for efficacy."

Answered by AI

Is this experiment a pioneering endeavor?

"Since 2017, the pharmaceutical company Eisai Inc. has been researching perampanel with its first clinical trial taking place in that year involving 60 participants. Since then, it was granted N/A approval and there are currently 11 studies for this drug happening across 51 cities spread over 9 countries."

Answered by AI

What outcome is expected from the completion of this clinical investigation?

"The primary result of this study, measured over 141 days, is the Steady-state peak concentration (Cmax,ss) of perampanel during the Maintenance Period. Secondary findings include changes in systolic and diastolic blood pressure, insulin-like growth factor 1 levels, and 12-lead electrocardiogram readings from Baseline to post-treatment visits."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy
2017. "Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02914314.
~3 spots leftby Apr 2025
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