Refractory EpilepsyPERLYONNCT02876289
Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)
An observational study of Refractory Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Perampanel is a non-competitive antagonist of the AMPA ( 2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, in 2012. Read more about this study
- Who is it for?
- Ages 16 to 86 years
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Perampanel
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Sep 2015
- 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 16 to 86 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with refractory focal epilepsy in which Perampanel were introduced between May 2014 and April 2015
Who may be able to join
- Patients with refractory focal epilepsy
- Initiation of perampanel between 05/2014 and 04/2015
Who cannot join
- Exact date of initiation of Perampanel not defined
- Patients without follow-up data
Trial locations and contacts
1 site in 1 country.
About this study
Perampanel is a non-competitive antagonist of the AMPA ( 2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and safety of perampanel as add-on treatment in patients with refractory epilepsy.
The investigators retrospectively collected and analyzed the data of patients with refractory epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The mean duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD = 2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%), dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).
- Conditions
- Refractory Epilepsy
- Being tested
- Perampanel
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
| Study group | Role | What they receive |
|---|---|---|
| patients treated with Perampanel | Not described Receives: Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
Proportion of patient still treated with Perampanel 6 months after its initiation
Measured: 6 months
Secondary outcomes (7)
Retention rate
Proportion of patients still treated with Perampanel 12 months after its initiation
Measured: 12 months
Seizure freedom
Proportion of seizure-free patients during at least 6 months
Measured: 6 months
Responder rates
Responder rates is defined as a reduction in seizure frequency of 50% or more compared with the three months before the initiation of perampanel.
Measured: 6 months
Responder rates
Responder rates is defined as a reduction in seizure frequency of 50% or more compared with the three months before the initiation of perampanel.
Measured: 12 months
Total withdrawal rate
Discontinuation rates at 6 months due to inefficiency or adverse effects
Measured: 6 months
Total withdrawal rate
Discontinuation rates at 12 months due to inefficiency or adverse effects
Measured: 12 months
Observed adverse effects during the observation period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain RHEIMS, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876289
- Sponsor's protocol ID
- 69HCL16_0556
- Acronym
- PERLYON
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)
- ClinicalTrials.gov ID
- NCT02876289
- Acronym / sponsor ID
- PERLYON / 69HCL16_0556
- Conditions
- Refractory Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Aug 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.
Perampanel is a non-competitive antagonist of the AMPA ( 2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and safety of perampanel as add-on treatment in patients with refractory epilepsy.
The investigators retrospectively collected and analyzed the data of patients with refractory epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The mean duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD = 2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%), dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients treated with Perampanel | – | Drug: Perampanel |
Who may qualify
- Ages
- 16 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with refractory focal epilepsy in which Perampanel were introduced between May 2014 and April 2015
Key inclusion criteria (2 listed)
- Patients with refractory focal epilepsy
- Initiation of perampanel between 05/2014 and 04/2015
Key exclusion criteria (2 listed)
- Exact date of initiation of Perampanel not defined
- Patients without follow-up data
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 |
|---|---|---|
| Perampanel | Drug | patients treated with Perampanel |
Primary outcome
Retention rate
Time frame: 6 months
Proportion of patient still treated with Perampanel 6 months after its initiation
7 secondary outcomes
Retention rate
Time frame: 12 months
Seizure freedom
Time frame: 6 months
Responder rates
Time frame: 6 months
Responder rates
Time frame: 12 months
Total withdrawal rate
Time frame: 6 months
Total withdrawal rate
Time frame: 12 months
Observed adverse effects during the observation period
Time frame: 12 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 24 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Sylvain RHEIMS principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
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 2 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 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Retention rate (time frame: 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 24 Aug 2016.