Partial Onset SeizuresNCT03836924
A Study to Assess Safety and Efficacy of Perampanel in Indian Participants as an Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Participants With Epilepsy Aged 12 Years or Older
An observational study of Partial Onset Seizures and Epilepsy, run by Eisai Pharmaceuticals India Pvt. Ltd at 12 sites in India.
Trial summary
The purpose of this study is to assess the safety of perampanel in the treatment of partial onset seizures in participants of age 12 years and older with epilepsy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Partial Onset Seizures, Epilepsy
- What is being tested?
- Perampanel
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 12 sitesIndia
- Study dates
- 18 Feb 2019to 1 Mar 2020
- 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: Indian participants with epilepsy aged 12 years or older.
Who may be able to join
- Participants prescribed perampanel for the adjunctive treatment of partial onset seizures based on independent clinical judgment of treating physicians.
Who cannot join
- Participation in another study involving administration of an investigational drug or device whilst participating in this observational study.
- Hypersensitivity [allergic] to perampanel.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
BGS Gleneagles Global Hospitals
Bengaluru, Karnataka, 560060
Shri Ganga Ram Hospital
Delhi
Nizam's Institute of Medical Sciences Department of Neurology
Hyderabad, Telangana, 500082
Advance Neurology & Superspeciality Hospital
Jaipur
Ramakrishna mission seva pratisthan vivekananda institute of medical sciences
Kolkata, West Bengal, 700026
Sri Aurobindo Seva Kendra
Kolkata, West Bengal, 700068
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014
Seth G S Medical College & KEM Hospital
Mumbai, Maharashtra, 400012
Brain Clinic, Jasleen Hospital
Nagpur, Maharashtra, 440012
Getwell Hospital and Research Institute
Nagpur, Maharashtra, 440012
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004
Lifepoint Multispecialty Hospital
Pune, Maharashtra, 411057
About this study
Official title: A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety & Efficacy of Perampanel in Indian Patients as An Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Patients With Epilepsy Aged 12 Years or Older
The purpose of this study is to assess the safety of perampanel in the treatment of partial onset seizures in participants of age 12 years and older with epilepsy.
- Conditions
- Partial Onset Seizures, Epilepsy
- Being tested
- Perampanel
- Keywords
- E2007, Fycompa, Perampanel, Prospective, Partial onset seizures, Epilepsy, Seizures
- 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 E2007, Fycompa
Perampanel tablets.
| Study group | Role | What they receive |
|---|---|---|
| Perampanel | Participants receiving perampanel tablets, orally according to prescribing information and the treating physician's clinical judgment will be observed prospectively for up to 6 months or participant withdrawal, whichever occurs first. Receives: Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to 6 months
Secondary outcomes (3)
Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period
Measured: Up to 6 months
Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period
Measured: Up to 6 months
Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period
Measured: At 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start18 Feb 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Onset SeizuresStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Pharmaceuticals India Pvt. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836924
- Sponsor's protocol ID
- E2007-M091-508
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2019
- Last updated
- 18 Feb 2021
- 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 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety & Efficacy of Perampanel in Indian Patients as An Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Patients With Epilepsy Aged 12 Years or Older
- ClinicalTrials.gov ID
- NCT03836924
- Acronym / sponsor ID
- E2007-M091-508
- Conditions
- Partial Onset Seizures, Epilepsy
- Keywords
- E2007, Fycompa, Perampanel, Prospective, Partial onset seizures, Epilepsy, Seizures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eisai Pharmaceuticals India Pvt. LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 11 Feb 2019 (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 this study is to assess the safety of perampanel in the treatment of partial onset seizures in participants of age 12 years and older with epilepsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perampanel | – | Drug: PerampanelParticipants receiving perampanel tablets, orally according to prescribing information and the treating physician's clinical judgment will be observed prospectively for up to 6 months or participant withdrawal, whichever occurs first. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Indian participants with epilepsy aged 12 years or older.
Key inclusion criteria (1 listed)
- Participants prescribed perampanel for the adjunctive treatment of partial onset seizures based on independent clinical judgment of treating physicians.
Key exclusion criteria (2 listed)
- Participation in another study involving administration of an investigational drug or device whilst participating in this observational study.
- Hypersensitivity [allergic] 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 |
|---|---|---|
| PerampanelAlso: E2007, FycompaPerampanel tablets. | Drug | Perampanel |
Primary outcome
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 6 months
3 secondary outcomes
Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period
Time frame: Up to 6 months
Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period
Time frame: Up to 6 months
Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period
Time frame: At 3 months and 6 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 18 Feb 2021.
- 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/.
Related trials for Partial Onset Seizures
Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Partial Epilepsy
Active, not recruiting
A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
RecruitingPhase 2
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
Focal Onset Seizures
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.
12 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 Onset Seizures and Epilepsy, run by Eisai Pharmaceuticals India Pvt. Ltd at 12 sites in India.
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 1 inclusion and 2 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India. 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 Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to 6 months). 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 Feb 2021.