Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.

NCT02727101 | Terminated Phase 4

• 1 other identifier: maes 008
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the present study is to evaluate ("screen") a large number (12) of different dual therapies of perampanel + another AED ("PMP+") for a large, 75-100% seizure frequency reduction. The design of the study will differ from usual AED studies. The study will be (i) open label, with (ii) a small n per group, n=6, with (iii) outcome measures a 'blockbuster effect': (a) ≥75 seizure frequency reduction; and (b) seizure freedom.

Conditions

Epilepsy

Keywords

Focal epilepsy, Perampanel

Outcome Measures

Primary Outcomes (3)

• responder rate

  responder rate, defined by \>75% seizure frequency reduction. Average seizure frequency per 4 weeks will be compared between the 12 weeks of "PMP+" maintenance treatment and 12 weeks of baseline.

  12 weeks

• seizure freedom rate

  seizure freedom rate. Proportion of responders and of subjects with seizure freedom in each treatment arm will be compared with historical data of 75% seizure reduction from pivotal phase 3 studies for which such data is publicly available

  12 weeks

• treatment discontinuation rate

  To evaluate the safety and tolerability of each perampanel+ combination with treatment discontinuation rate as the primary safety/tolerability outcome measure

  12 weeks

Study Arms (12)

phenobarbital

ACTIVE COMPARATOR

After 12 weeks of baseline observation on phenobarbital medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

valproate

ACTIVE COMPARATOR

After 12 weeks of baseline observation on valproate medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

lamotrigine

ACTIVE COMPARATOR

After 12 weeks of baseline observation on lamotrigine medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

levetiracetam

ACTIVE COMPARATOR

After 12 weeks of baseline observation on levetiracetam medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

zonisamide

ACTIVE COMPARATOR

After 12 weeks of baseline observation on zonisamide medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

pregabalin

ACTIVE COMPARATOR

After 12 weeks of baseline observation on pregabaline medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

lacosamide

ACTIVE COMPARATOR

After 12 weeks of baseline observation on lacosasmide medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

clobazam

ACTIVE COMPARATOR

After 12 weeks of baseline observation on clobazam medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

ezogabine

ACTIVE COMPARATOR

After 12 weeks of baseline observation on ezogabine medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

eslicarbazepine

ACTIVE COMPARATOR

After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

topiramate

ACTIVE COMPARATOR

After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

tiagabine

ACTIVE COMPARATOR

After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.

Drug: perampanel

Interventions

perampanel DRUG

Each group of 6 patients will be followed for 12 weeks of baseline observation on baseline medication. Seizure frequency will be counted, using subjects' self-reported seizure diaries. Perampanel will be titrated to 8-12 mg/day, with the final dose determined by side effects and tolerability of Perampanel at 8-12 mg/day doses. Titration will occur at the rate of 2 mg/week or two weeks, as tolerated.

Also known as: Fycompa

clobazam; eslicarbazepine; ezogabine; lacosamide; lamotrigine; levetiracetam; phenobarbital; pregabalin; tiagabine; topiramate; valproate; zonisamide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Stable focal epilepsy, with partial complex seizures including partial complex seizures with or without secondary generalization, partial simple seizures with a clear motor component with or without secondary generalization, and partial simple seizures with secondary generalization.
• Stable dose for at least 30 days of the chosen background AED dose
• Epilepsy duration for \> 2 years
• Past/current treatment with \> 4 AEDs. Vagal nerve stimulator treatment will be allowed and will not count as an AED. VNS setting must be stable for 3 months prior to enrollment.
• Seizure frequency of ≥1/month

You may not qualify if:

• Primary generalized epilepsy
• Simple partial seizures without motor components or secondary generalization
• Non-epileptic seizures
• Progressive neurological disease including growing neoplasm, CNS degenerative disorders including Alzheimer's disease, other forms of dementia
• Any systemic illness or unstable medical condition that might pose additional risk, including renal or liver disease, clinically uncontrolled cardiac disease, other unstable metabolic or endocrine disturbances, and active systemic cancer
• Change in the dose of any Antiepileptic Drug within 30 days prior to enrollment
• Psychosis within six months of enrollment.
• Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
• Pregnancy
• Use of any CNS-active investigational drugs within 3 months of enrollment.
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Sponsors & Collaborators

• Mid-Atlantic Epilepsy and Sleep Center, LLC: lead
• Eisai Inc.: collaborator

Study Sites (1)

MidAtlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

Location

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pavel Klein, M.B,B.Chir.

  Mid-Atlantic Epilepsy and Sleep Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle study investigator

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 4, 2016
• Study Start: November 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

US (1)