EpilepsyNCT02736162
Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Patients With Epilepsy
An observational study of Epilepsy and Partial-Onset Seizures, run by Eisai Inc..
Trial summary
The primary objective of this study is to assess the retention rate of perampanel when given as secondary monotherapy in routine clinical care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy, Partial-Onset Seizures, Primary Generalized Tonic-Clonic Seizures
- What is being tested?
- No treatment (intervention) was administered
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jul 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who received perampanel as primary or secondary monotherapy.
Who may be able to join
- Diagnosis of epilepsy
- Received perampanel as primary or secondary monotherapy at any time between 1 Jan 2013 and 15 Oct 2015
- Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records per local requirements
Who cannot join
- Not applicable
About this study
Official title: A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Routine Clinical Care in Patients With Epilepsy
The primary objective of this study is to assess the retention rate of perampanel when given as secondary monotherapy in routine clinical care.
Read the detailed description
This study is a retrospective study of participants who received perampanel as primary or secondary monotherapy at approximately 40 centers in Europe, Asia, and Australia. Primary monotherapy is defined as the administration of perampanel in the absence of any concomitant antiepileptic drugs (AEDs). Secondary (conversion) monotherapy is defined as the conversion of perampanel from adjunctive therapy to monotherapy by withdrawing concomitant AEDs.
- Being tested
- No treatment (intervention) was administered
- Keywords
- Perampanel, E2007, Phase 4, Fycompa
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment (intervention) was administeredOther
| Study group | Role | What they receive |
|---|---|---|
| Perampanel | Participants with a diagnosis of epilepsy who received perampanel as primary or secondary (conversion) monotherapy at any time between 1 Jan 2013 and 15 Oct 2015. Receives: Other: No treatment (intervention) was administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy
Measured: Month 3
Retention rate
The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy
Measured: Month 6
Retention rate
The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy
Measured: Month 12
Retention rate
The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy
Measured: Month 18
Retention rate
The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy
Measured: Month 24
Participants remaining on perampanel monotherapy (after conversion from perampanel as adjunctive therapy)
Measured: Up to approximately 34 months
Secondary outcomes (11)
Percentage of participants receiving perampanel monotherapy out of the total number of participants prescribed perampanel
Measured: Up to approximately 34 months
Percentage of participants with greater than or equal to 50% reduction in seizure frequency
Measured: Up to approximately 34 months
Percentage of participants who were seizure-free for at least 3 months
Seizure-free is defined as a terminal remission of seizures
Measured: Up to approximately 34 months
Percentage of participants with greater than or equal to 75% reduction in seizure frequency
Measured: Up to approximately 34 months
Percentage of participants with categorized percent reductions in seizure frequency
Measured: Up to approximately 34 months
Percentage of participants with no change or worsening of seizures
Measured: Up to approximately 34 months
Median percent change in seizure frequency
Measured: Up to approximately 34 months
Percentage of participants with treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
Measured: Up to approximately 34 months
Mean change in body weight
Measured: Up to approximately 34 months
Maximum dose of perampanel during adjunctive therapy and monotherapy
Measured: Up to approximately 34 months
Average dose of perampanel during adjunctive therapy and monotherapy
Measured: Up to approximately 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJul 2016
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.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Cartwright, PhD, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736162
- Sponsor's protocol ID
- E2007-G000-504
- Status last verified
- Mar 2017
- First submitted
- 30 Mar 2016
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Routine Clinical Care in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT02736162
- Acronym / sponsor ID
- E2007-G000-504
- Keywords
- Perampanel, E2007, Phase 4, Fycompa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 13 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 primary objective of this study is to assess the retention rate of perampanel when given as secondary monotherapy in routine clinical care.
Detailed description
This study is a retrospective study of participants who received perampanel as primary or secondary monotherapy at approximately 40 centers in Europe, Asia, and Australia. Primary monotherapy is defined as the administration of perampanel in the absence of any concomitant antiepileptic drugs (AEDs). Secondary (conversion) monotherapy is defined as the conversion of perampanel from adjunctive therapy to monotherapy by withdrawing concomitant AEDs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perampanel | – | Other: No treatment (intervention) was administeredParticipants with a diagnosis of epilepsy who received perampanel as primary or secondary (conversion) monotherapy at any time between 1 Jan 2013 and 15 Oct 2015. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who received perampanel as primary or secondary monotherapy.
Key inclusion criteria (3 listed)
- Diagnosis of epilepsy
- Received perampanel as primary or secondary monotherapy at any time between 1 Jan 2013 and 15 Oct 2015
- Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records per local requirements
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| No treatment (intervention) was administered | Other | Perampanel |
Primary outcome
Retention rate
Time frame: Month 3
The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy
Retention rate
Time frame: Month 6
The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy
Retention rate
Time frame: Month 12
The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy
Retention rate
Time frame: Month 18
The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy
Retention rate
Time frame: Month 24
The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy
Participants remaining on perampanel monotherapy (after conversion from perampanel as adjunctive therapy)
Time frame: Up to approximately 34 months
11 secondary outcomes
Percentage of participants receiving perampanel monotherapy out of the total number of participants prescribed perampanel
Time frame: Up to approximately 34 months
Percentage of participants with greater than or equal to 50% reduction in seizure frequency
Time frame: Up to approximately 34 months
Percentage of participants who were seizure-free for at least 3 months
Time frame: Up to approximately 34 months
Percentage of participants with greater than or equal to 75% reduction in seizure frequency
Time frame: Up to approximately 34 months
Percentage of participants with categorized percent reductions in seizure frequency
Time frame: Up to approximately 34 months
Percentage of participants with no change or worsening of seizures
Time frame: Up to approximately 34 months
Median percent change in seizure frequency
Time frame: Up to approximately 34 months
Percentage of participants with treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
Time frame: Up to approximately 34 months
Mean change in body weight
Time frame: Up to approximately 34 months
Maximum dose of perampanel during adjunctive therapy and monotherapy
Time frame: Up to approximately 34 months
Average dose of perampanel during adjunctive therapy and monotherapy
Time frame: Up to approximately 34 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
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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.
Karen Cartwright, PhD study director
Eisai Limited
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Partial-Onset Seizures, run by Eisai Inc..
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retention rate (time frame: Month 3). The study lists 6 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 9 Mar 2017.