EpilepsyPhase 4NCT02727101
Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.
A Phase 4 study testing perampanel in people with Epilepsy, run by Mid-Atlantic Epilepsy and Sleep Center, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- perampanel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MidAtlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
About this study
Official title: "Rational Polytherapy" Using Perampanel Dual Therapy Anticonvulsant Combination Treatments of Adults With Refractory Focal Epilepsy : a Pilot Study.
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.
Read the detailed description
Investigators will compare rates of seizure freedom and >75% seizure frequency reduction among 12 treatment arms consisting of 6 subjects each with refractory focal epilepsy treated with perampanel and one other AED ("PMP+"). Treatment arms will include (1) Perampanel +phenobarbital, (2) PMP+valproate, (3) PMP+ lamotrigine, (4) PMP + topiramate, (5) PMP + tiagabine, (6) PMP + levetiracetam, (7) PMP + zonisamide, (8) PMP + pregabalin, (9) PMP + lacosamide, (10) PMP+ clobazam, (11) PMP + ezogabine; and (12) PMP + eslicarbazepine. Each group of 6 will be followed for 12 weeks of baseline observation on baseline medication. Seizure frequency will be counted, using subjects' self-reported seizure diaries. PMP will be titrated to 8-12 mg/day, with the final dose determined by side effects and tolerability of PMP at 8-12 mg/day doses. Titration will occur at the rate of 2 mg/week or two weeks (in accordance with FDA labeling), as tolerated. Subjects will be observed for 12 weeks of maintenance treatment on the target PMP doses. Seizure frequency will be compared between the 12 weeks of baseline observation and 12 weeks of maintenance treatment.
- Conditions
- Epilepsy
- Being tested
- perampanel
- Keywords
- Focal epilepsy, Perampanel
- Medical subject headings
- Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perampanelDrug
Also called Fycompa
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.
| Study group | Role | What they receive |
|---|---|---|
| phenobarbital | Active comparator | After 12 weeks of baseline observation on phenobarbital medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
| valproate | Active comparator | After 12 weeks of baseline observation on valproate medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
| lamotrigine | Active comparator | After 12 weeks of baseline observation on lamotrigine medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
| levetiracetam | Active comparator | After 12 weeks of baseline observation on levetiracetam medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
| zonisamide | Active comparator | After 12 weeks of baseline observation on zonisamide medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
| pregabalin | Active comparator | After 12 weeks of baseline observation on pregabaline medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
| lacosamide | Active comparator | After 12 weeks of baseline observation on lacosasmide medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
| clobazam | Active comparator | After 12 weeks of baseline observation on clobazam medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
| ezogabine | Active comparator | After 12 weeks of baseline observation on ezogabine medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
| eslicarbazepine | Active comparator | After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
| topiramate | Active comparator | After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
| tiagabine | Active comparator | After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication. Receives: Drug: perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid-Atlantic Epilepsy and Sleep Center, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Principal investigator, Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC
- Investigators
- Pavel Klein, M.B,B.Chir., Principal investigator, Mid-Atlantic Epilepsy and Sleep Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727101
- Sponsor's protocol ID
- maes 008
- Status last verified
- Aug 2017
- First submitted
- 29 Mar 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Rational Polytherapy" Using Perampanel Dual Therapy Anticonvulsant Combination Treatments of Adults With Refractory Focal Epilepsy : a Pilot Study.
- ClinicalTrials.gov ID
- NCT02727101
- Acronym / sponsor ID
- maes 008
- Conditions
- Epilepsy
- Keywords
- Focal epilepsy, Perampanel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mid-Atlantic Epilepsy and Sleep Center, LLCUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Nov 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Investigators will compare rates of seizure freedom and >75% seizure frequency reduction among 12 treatment arms consisting of 6 subjects each with refractory focal epilepsy treated with perampanel and one other AED ("PMP+"). Treatment arms will include (1) Perampanel +phenobarbital, (2) PMP+valproate, (3) PMP+ lamotrigine, (4) PMP + topiramate, (5) PMP + tiagabine, (6) PMP + levetiracetam, (7) PMP + zonisamide, (8) PMP + pregabalin, (9) PMP + lacosamide, (10) PMP+ clobazam, (11) PMP + ezogabine; and (12) PMP + eslicarbazepine. Each group of 6 will be followed for 12 weeks of baseline observation on baseline medication. Seizure frequency will be counted, using subjects' self-reported seizure diaries. PMP will be titrated to 8-12 mg/day, with the final dose determined by side effects and tolerability of PMP at 8-12 mg/day doses. Titration will occur at the rate of 2 mg/week or two weeks (in accordance with FDA labeling), as tolerated. Subjects will be observed for 12 weeks of maintenance treatment on the target PMP doses. Seizure frequency will be compared between the 12 weeks of baseline observation and 12 weeks of maintenance treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| phenobarbital | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on phenobarbital medication, the treatment with perampanel will introduced as "add on" medication. |
| valproate | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on valproate medication, the treatment with perampanel will introduced as "add on" medication. |
| lamotrigine | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on lamotrigine medication, the treatment with perampanel will introduced as "add on" medication. |
| levetiracetam | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on levetiracetam medication, the treatment with perampanel will introduced as "add on" medication. |
| zonisamide | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on zonisamide medication, the treatment with perampanel will introduced as "add on" medication. |
| pregabalin | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on pregabaline medication, the treatment with perampanel will introduced as "add on" medication. |
| lacosamide | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on lacosasmide medication, the treatment with perampanel will introduced as "add on" medication. |
| clobazam | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on clobazam medication, the treatment with perampanel will introduced as "add on" medication. |
| ezogabine | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on ezogabine medication, the treatment with perampanel will introduced as "add on" medication. |
| eslicarbazepine | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication. |
| topiramate | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication. |
| tiagabine | Active comparator | Drug: perampanelAfter 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perampanelAlso: FycompaEach 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. | Drug | clobazam, eslicarbazepine, ezogabine, lacosamide, lamotrigine, levetiracetam, phenobarbital, pregabalin, tiagabine, topiramate, valproate, zonisamide |
Primary outcome
responder rate
Time frame: 12 weeks
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.
seizure freedom rate
Time frame: 12 weeks
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
treatment discontinuation rate
Time frame: 12 weeks
To evaluate the safety and tolerability of each perampanel+ combination with treatment discontinuation rate as the primary safety/tolerability outcome measure
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Klein, M.B,B.Chir. principal investigator
Mid-Atlantic Epilepsy and Sleep Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing perampanel in people with Epilepsy, run by Mid-Atlantic Epilepsy and Sleep Center, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
responder rate (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.