EpilepsyNCT04230044
A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With Epilepsy
An observational study of Epilepsy and Partial-onset Seizures, run by Eisai Co., Ltd..
Trial summary
The purpose of the study is to evaluate the safety and efficacy of Fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy, Partial-onset Seizures
- What is being tested?
- Perampanel
- Type of treatment
- Pill or oral medicine
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2016to 3 Jul 2017
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with epilepsy aged 12 years or older.
Who may be able to join
- Male and female participants aged 12 years and older
- Participants who were diagnosed with partial-onset seizures with or without secondarily generalized seizures.
- Participants who were appropriate to receive Fycompa® as an adjunctive treatment participants starting at Visit 0 according to investigator's judgment.
- Participants who had provided written informed consent
Who cannot join
- Participants not fit to receive Fycompa® as per the latest prescribing information.
- Participants who were participating in a clinical trial, at the time of the study.
- Participants who showed evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.) that in the opinion of the Investigators could affect the participant's safety or trial conduct.
- Participants who according to the Investigators would not be able to comply with study procedures.
About this study
Official title: A Post Marketing Observational Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Epilepsy Patients
The purpose of the study is to evaluate the safety and efficacy of Fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older.
- Conditions
- Epilepsy, Partial-onset Seizures
- Being tested
- Perampanel
- Keywords
- E2007, Fycompa, Perampanel, Partial onset seizures, Epilepsy, Seizures, Post marketing surveillance
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
Also called Fycompa, E2007
Perampanel tablets.
| Study group | Role | What they receive |
|---|---|---|
| Fycompa® (perampanel) | Fycompa® (perampanel) (oral tablets) treatment will be initiated at 2 milligram (mg) once daily according to the approved package insert, as an add-on drug in addition to other anti-epileptic drugs (AEDs) as prescribed by physician. The dose will be increased based on clinical response and tolerability (by increments of 2 mg/day to a maintenance dose of 4 to 12 mg/day) and participants will be enrolled and observed prospectively for up to 54 Weeks. Receives: Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
AESI will include medication errors, lack of therapeutic efficacy, overdose, abuse, misuse, occupational exposure, paternal exposure and off label use, pregnancy, and exposure to drug during breast feeding.
Measured: Up to 54 Weeks
Secondary outcomes (3)
Change From Baseline in 28-day Seizure Count at the End of Treatment Period (Week 52)
Measured: Baseline, Week 52
Response Rate
Response rate will be defined as number of participants with response defined as more than or equal to (>=) 50 percent (%) reduction in 28-day seizure frequency from Baseline.
Measured: Baseline, Week 12, Week 24 and Week 52
Change From Baseline in Clinical Global Impression of Change (CGIC) Scores
The CGIC is an assessment performed by the clinician, evaluating the change in the participant's symptoms over time. Assessment will be implemented based on frequency of seizure, severity of seizures, adverse events, and overall conditions on a 7-point scale with the scores as 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse.
Measured: Baseline, Week 12, Week 24 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start11 Apr 2016
- Primary completion3 Jul 2017
- Study completion3 Jul 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230044
- Sponsor's protocol ID
- E2007-M065-411
- Status last verified
- Nov 2019
- First submitted
- 13 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Observational Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Epilepsy Patients
- ClinicalTrials.gov ID
- NCT04230044
- Acronym / sponsor ID
- E2007-M065-411
- Conditions
- Epilepsy, Partial-onset Seizures
- Keywords
- E2007, Fycompa, Perampanel, Partial onset seizures, Epilepsy, Seizures, Post marketing surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 18 Jan 2020 (actual)
- 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 purpose of the study is to evaluate the safety and efficacy of Fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fycompa® (perampanel) | – | Drug: PerampanelFycompa® (perampanel) (oral tablets) treatment will be initiated at 2 milligram (mg) once daily according to the approved package insert, as an add-on drug in addition to other anti-epileptic drugs (AEDs) as prescribed by physician. The dose will be increased based on clinical response and tolerability (by increments of 2 mg/day to a maintenance dose of 4 to 12 mg/day) and participants will be enrolled and observed prospectively for up to 54 Weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with epilepsy aged 12 years or older.
Key inclusion criteria (4 listed)
- Male and female participants aged 12 years and older
- Participants who were diagnosed with partial-onset seizures with or without secondarily generalized seizures.
- Participants who were appropriate to receive Fycompa® as an adjunctive treatment participants starting at Visit 0 according to investigator's judgment.
- Participants who had provided written informed consent
Key exclusion criteria (4 listed)
- Participants not fit to receive Fycompa® as per the latest prescribing information.
- Participants who were participating in a clinical trial, at the time of the study.
- Participants who showed evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.) that in the opinion of the Investigators could affect the participant's safety or trial conduct.
- Participants who according to the Investigators would not be able to comply with study procedures.
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: Fycompa, E2007Perampanel tablets. | Drug | Fycompa® (perampanel) |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Time frame: Up to 54 Weeks
AESI will include medication errors, lack of therapeutic efficacy, overdose, abuse, misuse, occupational exposure, paternal exposure and off label use, pregnancy, and exposure to drug during breast feeding.
3 secondary outcomes
Change From Baseline in 28-day Seizure Count at the End of Treatment Period (Week 52)
Time frame: Baseline, Week 52
Response Rate
Time frame: Baseline, Week 12, Week 24 and Week 52
Change From Baseline in Clinical Global Impression of Change (CGIC) Scores
Time frame: Baseline, Week 12, Week 24 and Week 52
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 18 Jan 2020.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Partial-onset Seizures, run by Eisai Co., Ltd..
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 4 inclusion and 4 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 18 Jan 2020. 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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (time frame: Up to 54 Weeks). 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 18 Jan 2020.