EpilepsyNCT02033902
A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years
An observational study of Epilepsy, run by Eisai Inc. at 42 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Perampanel
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 42 sitesin 6 countries
- Study dates
- 6 Jun 2014to 31 Jan 2018
- 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: Epilepsy patients prescribed adjunctive treatment in countries where perampanel has received marketing approval. Multiple treating physicians will prescribe perampanel to patients, who then will be observed for approximately 52 weeks.
Who may be able to join
- Male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent
- Patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit
- Patients who provide informed consent
Who cannot join
- Participation in another study involving administration of an investigational drug or device whilst participating in this observational study
- Prior participation in a perampanel clinical study
- Hypersensitivity to perampanel
Trial locations and contacts
42 sites in 6 countries.
42 sites in 6 countries
Israel12 sites
Eisai Site# 2013
Beersheba
Rambam Medical Center
Haifa, 31096
Edith Wolfson Medical Center
Holon, 58100
Kiryat Hadassah
Jerusalem
Meir Medical Center
Kfar Saba, 4428164
Western Galilee Hospital
Nahariya, 22100
Schneider Children's Medical Center Of Israel
Petah Tikva, 49202
The Chaim Sheba Medical Center
Ramat Gan
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Eisai Site# 2003
Tel Aviv
Eisai Site# 2012
Tel Aviv
Eisai Site# 2008
Tel HaShomer
Belgium10 sites
Eisai Site# 2405
Battice
Hôpital Erasme
Brussels, 1070
Eisai Site# 2404
Brussels
Eisai Site# 2406
Duffel
Uz Leuven
Leuven, 3000
Eisai Site# 2409
Liège
Eisai Site# 2403
Ottignies
Eisai Site# 2408
Ruddershove
Eisai Site# 2407
Woluwe-Saint-Lambert
Eisai Site# 2402
Yvoir
United Kingdom9 sites
Eisai Site# 1607
Bristol
Ninewells Hospital
Dundee, Dd1 9Sy
Eisai Site# 1611
Lincoln
Eisai Site# 1604
London
Eisai Site# 1608
London
Eisai Site# 1609
London
Great Ormond Street hospital
London
Eisai Site# 1612
Newcastle
Eisai Site# 1606
Truro
Czechia6 sites
Eisai Site# 2601
Beroun
Eisai Site# 2600
Brno
Eisai Site# 2606
Hradec Králové
Eisai Site# 2602
Náchod
Cerebrovaskularni Poradna S.R.O.
Ostrava, 72200
Eisai Site# 2603
Prague
Austria3 sites
Universitatsklinikum Innsbruck
Innsbruck, 6020
Kepler Universitätsklinikum
Linz, 4020
Krankenhaus Wien-Hietzing
Vienna, 1130
Sweden2 sites
Sahlgrenska Universitetssjukhuset
Gothenburg, SE-41345
Universitetssjukhuset I Linköping
Linköping, 58185
About this study
The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.
Read the detailed description
This is a global, observational, cohort study in patients with epilepsy. Multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.
- Conditions
- Epilepsy
- Being tested
- Perampanel
- Keywords
- Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment
| Study group | Role | What they receive |
|---|---|---|
| Perampanel | Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment Receives: Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Emergent Adverse Events (TEAEs) of interest
Assessment of events of dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction.
Measured: Up to 52 weeks and 2 weeks of follow-up
Secondary outcomes (5)
Incidence of unintended pregnancy
Measured: Up to 52 weeks
Incidence of off-label use
Measured: Up to 52 weeks
Summary scores for the Hospital Anxiety and Depression Scale (HADS)
Measured: Screening, Week 52
Number of TEAEs in the patient subpopulations of interest
TEAEs observed in the specified subpopulations of patients could also be made in order to get a better understanding of whether any of these particular potential risk factors (e.g., old age, cardiovascular disease) define groups with greater or lesser risk.
Measured: Up to 52 weeks and 2 weeks of follow-up
Clinical Global Impression of Change
Assessment of disease severity will utilize the Clinical Global Impression of Change (CGI-C) scale at end of treatment to evaluate change in disease status since initiation of treatment.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study start6 Jun 2014
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033902
- Sponsor's protocol ID
- E2007-G000-402
- Status last verified
- Nov 2015
- First submitted
- 17 Dec 2013
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.
PubMed 35305920Maguire M, Ben-Menachem E, Patten A, Malhotra M, Ngo LY. A post-approval observational study to evaluate the safety and tolerability of perampanel as an add-on therapy in adolescent, adult, and elderly patients with epilepsy. Epilepsy Behav. 2022 Jan;126:108483. doi: 10.1016/j.yebeh.2021.108483. Epub 2021 Dec 23.
PubMed 34953337
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years
- ClinicalTrials.gov ID
- NCT02033902
- Acronym / sponsor ID
- E2007-G000-402
- Conditions
- Epilepsy
- Keywords
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2014
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 13 Jan 2014 (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 purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.
Detailed description
This is a global, observational, cohort study in patients with epilepsy. Multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perampanel | – | Drug: PerampanelPerampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Epilepsy patients prescribed adjunctive treatment in countries where perampanel has received marketing approval. Multiple treating physicians will prescribe perampanel to patients, who then will be observed for approximately 52 weeks.
Key inclusion criteria (3 listed)
- Male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent
- Patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit
- Patients who provide informed consent
Key exclusion criteria (3 listed)
- Participation in another study involving administration of an investigational drug or device whilst participating in this observational study
- Prior participation in a perampanel clinical study
- Hypersensitivity to perampanel
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 |
|---|---|---|
| PerampanelPerampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment | Drug | Perampanel |
Primary outcome
Number of Treatment Emergent Adverse Events (TEAEs) of interest
Time frame: Up to 52 weeks and 2 weeks of follow-up
Assessment of events of dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction.
5 secondary outcomes
Incidence of unintended pregnancy
Time frame: Up to 52 weeks
Incidence of off-label use
Time frame: Up to 52 weeks
Summary scores for the Hospital Anxiety and Depression Scale (HADS)
Time frame: Screening, Week 52
Number of TEAEs in the patient subpopulations of interest
Time frame: Up to 52 weeks and 2 weeks of follow-up
Clinical Global Impression of Change
Time frame: 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 7 Sep 2018.
- Derived from this study: PubMed 35305920Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.
- Derived from this study: PubMed 34953337Maguire M, Ben-Menachem E, Patten A, Malhotra M, Ngo LY. A post-approval observational study to evaluate the safety and tolerability of perampanel as an add-on therapy in adolescent, adult, and elderly patients with epilepsy. Epilepsy Behav. 2022 Jan;126:108483. doi: 10.1016/j.yebeh.2021.108483. Epub 2021 Dec 23.
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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.
42 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Eisai Inc. at 42 sites in 6 countries.
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 3 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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Israel, Belgium, United Kingdom, Czechia, Austria and 1 more country. 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 Treatment Emergent Adverse Events (TEAEs) of interest (time frame: Up to 52 weeks and 2 weeks of follow-up). 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 NCT02033902, which also lists 2 linked publications.
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 7 Sep 2018.