Perampanel Tablet for Aura

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Childrens Hospital Colorado, Aurora, CO
Aura+4 More
Perampanel Tablet - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a medication may help reduce seizures in children with epilepsy.

See full description

Eligible Conditions

  • Aura
  • Partial-onset Seizures
  • Pediatric Epileptic Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Aura

Study Objectives

This trial is evaluating whether Perampanel Tablet will improve 1 primary outcome and 32 secondary outcomes in patients with Aura. Measurement will happen over the course of Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56.

Week 56
Change From Baseline in the Cognitive Drug Research (CDR) at the End of the Treatment Period of Core Study and at the End of Extension Phase
Change from Baseline in CBCL at the End of the Treatment Period of Core Study and at the End of Extension Phase
Week 56
Change from Baseline in Number of Seizures Recorded on Electroencephalogram (EEG) at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Week 56
Change from Baseline in Number of Seizures Recorded on Electroencephalogram (EEG) at the End of the Treatment Period of Core Study and at the End of Extension Phase
Week 56
Change From Baseline in the Cognitive Drug Research (CDR) Parameter at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Change from Baseline in CBCL Parameters at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Change from Baseline in Growth and Development Parameter - Free Triiodothyronine (fT3) and Free Thyroxine (fT4) Levels in Blood
Change from Baseline in Growth and Development Parameter - Insulin Like Growth Factors (IGF)-1
Change from Baseline in Growth and Development Parameter - Thyroid-Stimulating Hormone (TSH) Levels in Blood
Change from Baseline in Growth and Development Parameter- Sexual Maturation Assessed by Tanner Staging
Change from Baseline in Lafayette Grooved Pegboard Test (LGPT) Parameters at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Week 28
Change from Baseline in Growth and Development Parameter - Height
Week 28
Change from Baseline in Growth and Development Parameter - Weight
Week 56
Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase A
Percent Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase A
Week 56
Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase
Percent Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase
Week 56
Clinical Global Impression of Change (CGIC) at the End of the Treatment Period of Core Study and at the End of Extension Phase
Subject Global Impression of Change (SGIC) at the End of the Treatment Period of Core Study and at the End of Extension Phase
Week 60
Number of Participants with Clinically Notable Vital Sign Results
Number of Participants with at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Week 60
Number of Participants with Clinically Significant Abnormal Electrocardiograms
Number of Participants with Treatment Emergent Markedly Abnormal Laboratory Values
Week 56
Proportion of 25% and 75% Responders for all Seizures, During Maintenance Period of Core Study and During Treatment Period of Core Study and Extension Phase A
Proportion of Participants Who Are Seizure-Free During the Maintenance Period of Core Study and During the Treatment Period of Core Study and Extension Phase A
Week 56
Proportion of 25% and 75% Responders for all Seizures, During Maintenance Period of Core Study and During Treatment Period of Core Study and Extension Phase
Proportion of Participants Who Are Seizure-Free During the Maintenance Period of Core Study and During the Treatment Period of Core Study and Extension Phase
Week 56
Proportion of 50% Responders During Treatment Period of Core Study and Extension Phase A
Week 56
Proportion of 50% Responders During Treatment Period of Core Study and Extension Phase
Week 56
Clinical Global Impression of Change (CGIC) at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Subject Global Impression of Change (SGIC) at the End of the Treatment Period of Core Study and at the End of Extension Phase A
Week 28
Proportion of Participants with any Treatment-Emergent Reports of Suicidal Ideation and Behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) and Intensity of These Behaviors Assessed using C-SSRS Scores
Week 23
Proportion of 50% Responders For All Seizures During the Maintenance Period of Core Study

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Aura

Trial Design

1 Treatment Group

Perampanel
1 of 1
Experimental Treatment

This trial requires 100 total participants across 1 different treatment group

This trial involves a single treatment. Perampanel Tablet is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

PerampanelParticipants aged 1 month to less than 18 years with pediatric epileptic syndrome (Cohort 1) or aged 1 month to less than 2 years with POS (Cohort 2) will receive perampanel oral suspension or perampanel tablets, once daily up to 56 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perampanel
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: treatment period of core study: weeks 0, 2, 5, 8, 10, 14, 18, and 23; extension phase a: weeks 28, 46, 56 and 60
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly treatment period of core study: weeks 0, 2, 5, 8, 10, 14, 18, and 23; extension phase a: weeks 28, 46, 56 and 60 for reporting.

Closest Location

Childrens Hospital Colorado - Aurora, CO

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Have a diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) or epilepsy with POS with or without secondary generalization (Cohort 2).
Currently maintained on stable doses of 1 to a maximum of 4 approved antiepileptic drugs (AEDs). A prescription medical marijuana (including products containing cannabidiol) is counted as 1 of the maximum of 4 allowed AEDs; however, it cannot be the only concomitant AED if this product is not an approved AED in the country where the study site is located. Doses must be stable for at least 4 weeks (at least 2 weeks for participant less than [<] 6 months old) before Visit 1/Baseline or screening; only 1 enzyme-inducing antiepileptic drug (EIAED) (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 4 AEDs is allowed.
Cohort 1: participants must be at least 1 month of age at the time of informed consent/assent show original
You have had at least 4 seizures in the 4-week interval prior to enrollment. show original
Absence of any progressive cause of epilepsy that has been confirmed clinically or based on brain imaging (example, magnetic resonance imaging [MRI] scan or computed tomography [CT] or ultrasound [for less than 1 year old]). show original

Patient Q&A Section

What are the signs of familial epilepsies?

"There is a significant amount of literature documenting the use of EEG as a standard method of diagnosing epilepsies. However, many of these studies focus only on focal brain pathology. As epileptic seizures are the most common form of seizure phenomenology, there is always a significant possibility that EEGs in epilepsy patients may show focal alterations in EEG readings. The most common of these is focal slowing, which is associated with frontal and temporal cortical areas. The presence of this phenomenon has been reported in the majority of studies of patients with focal epilepsies. Further research is required, but if it is confirmed, the EEG should be considered an important means of further identifying this condition." - Anonymous Online Contributor

Unverified Answer

How many people get familial epilepsies a year in the United States?

"The incidence of familial epilepsies is still rising and thus the incidence of familial epilepsies is likely to continue increasing, which indicates that the frequency of these diseases is increasing over time." - Anonymous Online Contributor

Unverified Answer

What causes familial epilepsies?

"Variants in the SCN1A gene are related to both infantile-onset spasms and familial partial epilepsy. In our patient family, we have confirmed the mutation as a potential cause of epilepsy in four unrelated members of the same family. In the light of these and previous findings, it is hypothesized that SCN1A deficiency may lead to epilepsy. The pathophysiology of this disease should be further studied." - Anonymous Online Contributor

Unverified Answer

What are common treatments for familial epilepsies?

"As the prevalence of epilepsy is increasing in the older generations of the society, the development of a proper therapeutic approach in this group could be a major priority for both neurologists and general practitioners." - Anonymous Online Contributor

Unverified Answer

Can familial epilepsies be cured?

"There is some evidence that familial epilepsies are curable, with seizure control in many cases by the age of three to five years. In addition, surgical treatment may be effective in a minority of cases. More prospective studies of this intriguing hypothesis are needed." - Anonymous Online Contributor

Unverified Answer

What is familial epilepsies?

"There are hundreds of different family histories of familial epilepsies. The occurrence of epilepsy is variable, but atypical in many of the families. Epilepsies may occur singly within families or in addition to other neurological problems." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating familial epilepsies?

"There have been no definitive breakthrough for the existing clinical therapies for familial epilepsies. While more studies have to be done, it appears hard to find an effective solution for these diseases." - Anonymous Online Contributor

Unverified Answer

Does perampanel tablet improve quality of life for those with familial epilepsies?

"Perampanel tablets significantly improved all aspects of QOL of those with FES compared to placebo across a range of measures. Data from a recent study suggest that more long-term prospective controlled randomized studies investigating QOL outcomes are warranted, and that further studies should explore dosage considerations for higher seizure-free rates." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving perampanel tablet?

"Perampanel is a first-line treatment for the treatment of partial epilepsy. It works best in patients with temporal lobe-related epilepsy. In patients with juvenile myoclonic epilepsy, it reduces seizures in half of the patients. We believe the evidence in this article shows the benefits of perampanel tablet." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of perampanel tablet?

"The common side effects of perampanel in Chinese patients are headache, dizziness, fatigue and drowsiness without insomnia, nausea and constipation. The side effects of perampanel can be greatly improved by adjusting the dosing schedule of the drug according to the individual condition." - Anonymous Online Contributor

Unverified Answer

Does familial epilepsies run in families?

"The familial occurrence of epilepsy in our study family is consistent with reports in the medical literature, and may be related to a novel gene on chromosome 6q24-q27." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of familial epilepsies?

"The causes of familial epilepsy differ from sporadic, non-symptomatic epilepsy. Furthermore, even among those affected by some symptom, the underlying etiology can still be elusive. For this reason, multiple genetic and environmental factors may influence the etiology of familial epilepsy, and the identification of these factors remains difficult." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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