Partial Seizures (With or Without Secondary Generalized Seizures)FYC01SNCT03059329
Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
An observational study of Partial Seizures (With or Without Secondary Generalized Seizures) and Primary Generalized Tonic-clonic Seizures, run by Eisai Co., Ltd. at 2 sites in Japan.
Trial summary
The objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: 1. unknown adverse drug reactions (ADRs); 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Seizures (With or Without Secondary Generalized Seizures), Primary Generalized Tonic-clonic Seizures
- What is being tested?
- Fycompa
- Type of treatment
- Pill or oral medicine
- How many people
- 3,809 participants
- Where
- 2 sitesJapan
- Study dates
- 1 Aug 2016to 13 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with epilepsy who will receive Fycompa per the approved indication in routine clinical practice
Who may be able to join
- Epilepsy participants at least 18 years of age with:
- Partial seizures (with or without secondary generalized seizures)
- Primary generalized Tonic-clonic seizures
Who cannot join
- Participants previously treated with Fycompa
Trial locations and contacts
2 sites in 1 country.
About this study
The objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:
- unknown adverse drug reactions (ADRs);
- occurrence of ADRs;
- factors that are likely to affect safety and efficacy;
- occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
- occurrence of psychiatric adverse events as priority investigation items (eg, aggression).
- Conditions
- Partial Seizures (With or Without Secondary Generalized Seizures), Primary Generalized Tonic-clonic Seizures
- Being tested
- Fycompa
- Keywords
- adult epilepsy participants, partial seizures, primary generalized Tonic-clonic seizures
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FycompaDrug
The usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs. The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg.
| Study group | Role | What they receive |
|---|---|---|
| Fycompa-treated epilepsy participants | Adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa Receives: Drug: Fycompa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with any serious adverse event
Measured: from 0 to 52 weeks
Number of participants with any non-serious adverse event
Measured: from 0 to 52 weeks
Secondary outcomes (2)
Number of participants experiencing seizures
Measured: from 0 to 52 weeks
Overall improvement rating in seizure frequency
Measured: from 0 to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Aug 2016
- Primary completion13 Sep 2019
- Study completion13 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial Seizures (With or Without Secondary Generalized Seizures)Studies 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
- 3,809 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenta Sumitomo, Study director, Drug Fostering and Evolution Coordination Department. Medical Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059329
- Sponsor's protocol ID
- E2007-M081-502
- Acronym
- FYC01S
- Status last verified
- Apr 2020
- First submitted
- 17 Feb 2017
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Inoue Y, Sumitomo K, Matsutani K, Ishii M. Evaluation of real-world effectiveness of perampanel in Japanese adults and older adults with epilepsy. Epileptic Disord. 2022 Feb 1;24(1):123-132. doi: 10.1684/epd.2021.1369.
PubMed 34782307
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
- ClinicalTrials.gov ID
- NCT03059329
- Acronym / sponsor ID
- FYC01S / E2007-M081-502
- Conditions
- Partial Seizures (With or Without Secondary Generalized Seizures), Primary Generalized Tonic-clonic Seizures
- Keywords
- adult epilepsy participants, partial seizures, primary generalized Tonic-clonic seizures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,809 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 13 Sep 2019 (actual)
- Study completion
- 13 Sep 2019 (actual)
- First posted
- 23 Feb 2017 (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 objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:
- unknown adverse drug reactions (ADRs);
- occurrence of ADRs;
- factors that are likely to affect safety and efficacy;
- occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
- occurrence of psychiatric adverse events as priority investigation items (eg, aggression).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fycompa-treated epilepsy participants | – | Drug: FycompaAdult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with epilepsy who will receive Fycompa per the approved indication in routine clinical practice
Key inclusion criteria (3 listed)
- Epilepsy participants at least 18 years of age with:
Key exclusion criteria (1 listed)
- Participants previously treated with Fycompa
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 |
|---|---|---|
| FycompaThe usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs. The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg. | Drug | Fycompa-treated epilepsy participants |
Primary outcome
Number of participants with any serious adverse event
Time frame: from 0 to 52 weeks
Number of participants with any non-serious adverse event
Time frame: from 0 to 52 weeks
2 secondary outcomes
Number of participants experiencing seizures
Time frame: from 0 to 52 weeks
Overall improvement rating in seizure frequency
Time frame: from 0 to 52 weeks
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 2 Mar 2022.
- Results publication: PubMed 34782307Inoue Y, Sumitomo K, Matsutani K, Ishii M. Evaluation of real-world effectiveness of perampanel in Japanese adults and older adults with epilepsy. Epileptic Disord. 2022 Feb 1;24(1):123-132. doi: 10.1684/epd.2021.1369.
- Individual participant dataSharing planned: No
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.
Kenta Sumitomo study director
Drug Fostering and Evolution Coordination Department. Medical Division
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Partial Seizures (With or Without Secondary Generalized Seizures) and Primary Generalized Tonic-clonic Seizures, run by Eisai Co., Ltd. at 2 sites in Japan.
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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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.
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 any serious adverse event (time frame: from 0 to 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03059329, which also lists 1 linked publication.
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 2 Mar 2022.