perampanel for Aura

Phase-Based Estimates
1
Effectiveness
2
Safety
Children's Clinical University Hospital, Riga, Latvia
Aura
perampanel - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Aura

Study Summary

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

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether perampanel will improve 6 primary outcomes and 12 secondary outcomes in patients with Aura. Measurement will happen over the course of Up to Week 52.

113 Days
Area under the concentration versus time curve at steady state (AUCss) of perampanel during the Maintenance Period of the Core Study (Non-EIAED)
Average steady-state drug concentration (Css,av) of perampanel during the Maintenance Period of the Core Study (Non-EIAED)
Steady-state peak concentration (Cmax,ss) of perampanel during the Maintenance Period of the Core Study (Non-EIAED)
141 Days
Area under the concentration versus time curve at steady state (AUCss) of perampanel during the Maintenance Period of the Core Study (EIAED)
Average steady-state drug concentration (Css,av) of perampanel during the Maintenance Period of the Core Study (EIAED)
Steady-state peak concentration (Cmax,ss) of perampanel during the Maintenance Period of the Core Study (EIAED)
Up to Week 52
Mean change from Baseline in 12-lead electrocardiogram (ECG) findings
Mean change from Baseline in body temperature
Mean change from Baseline in head circumference
Mean change from Baseline in height
Mean change from Baseline in insulin-like growth factor 1 (IGF-1)
Mean change from Baseline in pulse rate
Mean change from Baseline in respiratory rate
Mean change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Mean change from Baseline in the indicated clinical laboratory parameters
Mean change from Baseline in thyroid stimulating hormone (TSH), free triiodothyronine (fT3), and free thyroxine (fT4)
Mean change from Baseline in weight
Up to Week 56
Number of participants with any treatment-emergent adverse events (TEAEs) and any TE serious adverse event (SAE)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Perampanel 2mg
Somnolence
12%
Dizziness
10%
Headache
9%
Upper respiratory tract infection
6%
Fatigue
4%
Nasopharyngitis
4%
Gait disturbance
1%
Ankle fracture
1%
Goitre
1%
Confusional state
1%
Delirium
1%
Aggression
1%
Nephrolithiasis
1%
Soft tissue necrosis
0%
Head injury
0%
Benign lung neoplasm
0%
Traumatic brain injury
0%
Bone erosion
0%
Tremor
0%
Aortic stenosis
0%
Convulsion
0%
Conjunctivitis allergic
0%
Ecchymosis
0%
Road traffic accident
0%
Wound infection
0%
Post concussion syndrome
0%
Contusion
0%
Transient ischaemic attack
0%
Iritis
0%
Cholelithiasis
0%
Orchitis
0%
Simple partial seizures
0%
Grand mal convulsion
0%
Medical device removal
0%
Appendicitis
0%
Bronchitis
0%
Rib fracture
0%
Diabetes mellitus
0%
Epilepsy
0%
This histogram enumerates side effects from a completed 2010 Phase 3 trial (NCT00700310) in the Perampanel 2mg ARM group. Side effects include: Somnolence with 12%, Dizziness with 10%, Headache with 9%, Upper respiratory tract infection with 6%, Fatigue with 4%.

Trial Design

2 Treatment Groups

Control
Perampanel up to 12 or 16 mg/day

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Perampanel 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.

Perampanel up to 12 or 16 mg/day
Drug
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).
ControlNo treatment in the control group
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: 141 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 141 days for reporting.

Closest Location

Children's Hospital at Saint Peter's University Hospital - New Brunswick, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The person must have epilepsy with any type of seizure, as defined by the ILAE's Classification of Epileptic Seizures from 1981 show original
The person visited a doctor and had a brain imaging test (CT or MRI) which ruled out a progressive cause of epilepsy. show original
At the moment, 1 to 4 antiepileptic drugs are being used to treat the subject, with the dose unchanged for at least 5 half-lives show original
Patients must have been taking their current antiepileptic drugs (AEDs) for at least two weeks or five half-lives, whichever is longer, before their first visit. show original
Before the first visit, the subject must have stopped taking any medications that are known to interact with the study drug show original
The text states that the person has had one or more seizures before the first visit. show original
From one month to less than four years of age, any male or female who is at least 36 weeks gestational age can provide consent. show original
to protect you and your device We advise having a minimum weight of 4 kg (8.8 lb) to protect you and your device. show original
If you are entering the Extension Phase, you must have completed the last visit of the Maintenance Period of the Core Study. show original

Patient Q&A Section

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

Can aura be cured?

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There are many other conditions with similar symptomatology, and it is important to be aware of them in every patient presenting with a similar aura.

Unverified Answer

What is aura?

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Aura is an ominous feeling of impending doom, pain, discomfort, and/or disorientation that may arise before a transient illness develops into more serious illness—a pre-epidemic condition. It often has no known underlying medical cause and is of particular concern to women. aura is a common phenomenon that can be diagnosed and treated and is unlikely to be life-threatening. For all persons, though, it is important to report those symptoms to healthcare providers for appropriate diagnosis and treatment. The word is from Greek: “aura”, meaning aura, “breath”.

Unverified Answer

What causes aura?

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The evidence for a causal relationship between the aura of a migraine and the migraine headache is circumstantial. The link is in the brain circuitry which is affected when there is a disturbance in neurons. The key features of the aura include visual field defects, visual imagery, and emotional changes. The role of the aura in triggering migraine with aura is complex and its significance as a diagnostic clue to identifying migraines as migraine depends on its interpretation by the observer.

Unverified Answer

What are the signs of aura?

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The diagnosis can be made using a simple approach when the patients have some signs of aura that do not necessarily correspond to the name of this condition.

Unverified Answer

How many people get aura a year in the United States?

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Although some studies suggest that a lifetime prevalence of aura of 6-12% might be a typical figure, the true extent of aura could be much higher. A systematic review of the literature suggests that aura may be as common as a co-morbidity in some populations; it should be considered not only as something which may be experienced, but also as something which may be diagnosed at various points in life.

Unverified Answer

What are common treatments for aura?

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The data herein have provided some general guidelines for the management of auras and will assist clinicians and research investigators as they attempt to determine treatments specific to the particular aura disorder.

Unverified Answer

How does perampanel work?

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The study results suggest that the treatment reduces the mean number of auras and the intensity of their overall pain. The treatment shows a significant statistical trend to reduce the intensity of aura and the corresponding scores in the group of women in comparison to other studies; and reduces the number of auras, but without achieving a statistical significance (P=0.101).

Unverified Answer

Have there been any new discoveries for treating aura?

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There is a need to establish the correct diagnosis of patients who present with auras. The differential diagnosis of aura should be explored as aura (psychosis). If a patient presents with auras, the following should be recorded: age, current symptoms, history of illness, and possible underlying causes such as head trauma.

Unverified Answer

What does perampanel usually treat?

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When a seizure patient reports perampanel-like symptoms, hens, and especially the patient's spouse, should be aware that perampanel is associated with a high risk of serious seizures. Patients taking perampanel must be carefully monitored. If they have perampanel-like symptoms, they should be referred to a seizure service quickly.

Unverified Answer

How serious can aura be?

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The severity of the symptoms of typical aura is as great as or more intense than the symptoms of other types of aura and can affect the quality of life of patients and their families.

Unverified Answer

Does aura run in families?

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An elevated prevalence of familial auras and prodrome in a large family, the Liddle family with one third of the previous auras in the parents, was found and could be confirmed.

Unverified Answer

Does perampanel improve quality of life for those with aura?

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In this preliminary study, patients receiving Perampanel had a statistically significant improvement in general symptoms of depression, and marginally significant improvements in QoL as measured by the QALY, compared to placebo. Patients enrolled in this trial should therefore be advised to take Perampanel for a minimum of 16 weeks to maximize the potential for treatment change.

Unverified Answer
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