Refractory Partial SeizuresPhase 2NCT00903786
A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
A Phase 2 study testing perampanel in people with Refractory Partial Seizures, run by Eisai Co., Ltd. at 9 sites in Japan.
Trial summary
The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Refractory Partial Seizures
- What is being tested?
- perampanel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 9 sitesJapan
- Study dates
- 17 Jun 2009to 31 Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who consent to the study entry on their free will before starting any trial-related activities.
- Patients who participated in Study 231 and completed the required evaluation period (10 weeks).
- Patients who are certainly and voluntarily able to participate in this study and record their seizures by themselves or have family members or caregivers (or nurses, if hospitalized) record the seizures. Patients who wish to continue perampanel treatment and necessitate receiving the long- term administration judged by the investigator or sub-investigator.
Who cannot join
- Pregnant or lactating women, women of child-bearing potential, women willing to become pregnant.
- Patients who are ineligible judged by the investigator or sub investigator in light of medical history or complication at enrollment in treatment period.
- Patients who operate heavy equipment or drive should not be recruited into the study.
- Patients who are ineligible for study entry judged by the investigator or sub-investigator.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Study site
Kitakyushu, Fukuoka
Study site
Kobe, Hyōgo
Study site
Kodaira, Tokyo
Study site
Komatsushimachō, Tokushima
Study site
Kyoto
Study site
Nagasaki
Study site
Niigata
Study site
Sendai, Miyagi
Study site
Shizuoka
About this study
The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.
- Conditions
- Refractory Partial Seizures
- Being tested
- perampanel
- Keywords
- Seizure, epilepsy
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perampanelDrug
Also called E2007, Fycompa
Patients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231.
| Study group | Role | What they receive |
|---|---|---|
| Perampanel | Experimental | Participants were treated with the perampanel dose that was administered in maintenance period of Study E2007-J081-231 (Study 231) [NCT00849212]. In some instances, a 1-step down-titration from the viewpoint of safety and up-titration to the maintenance dose of Study 231 was allowed. In general, 1 to 6 tablets of perampanel was administered orally as a 2-milligram (mg) tablet (2 mg to 12 mg) once daily before bedtime (under fed conditions as much as possible).
The investigator, or subinvestigator, was allowed to complete the treatment by tapering the study drug after end of treatment or discontinuation (Follow-up Period), as appropriate. The taper period was 4 weeks at the longest. 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) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
Safety was assessed by monitoring adverse events (AEs), adverse drug reactions, clinical laboratory parameters, vital signs, 12-lead electrocardiogram, and dependency questionnaire. AEs were graded on a 3-point scale; 1) mild: (Grade 1) discomfort noticed, but no disruption of normal daily activity, 2) moderate: (Grade 2) discomfort reduced or affected normal daily activity, and 3) severe: (Grade 3) incapacitating, with inability to work or to perform normal daily activity. AE severity associated with abnormal changes in laboratory parameters was assessed using the Ministry of Health and Welfare Notification Number 80 "Classification of Severity of Adverse Drug Reactions of Medicinal Products". TEAEs were defined as AEs that emerged during treatment (absent at pretreatment [Baseline]), reemerged during treatment (were present at pretreatment but stopped before treatment), or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.
Measured: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 7 years 2 months
Secondary outcomes (4)
Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316
Seizure frequency was derived from information (seizure count and type) recorded in the participant diary. The seizure frequency per 28 days was calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. Of the 21 participants, 20 participants concomitantly used at least 1 inducer anti-epileptic drug (AED) (carbamazepine, phenytoin, phenobarbital, or primidone), and 1 participant used only non-inducer AEDs. The data is presented as median percent change with full range.
Measured: From Week 1 through Week 316 and Follow-up Period of the Extension Study, up to approximately 7 years 2 months
Responder Rate During the Treatment Period-LOCF
Responder rate (percentage of participants with greater than or equal to 50% reduction in seizure frequency for 28 days in the Treatment Period relative to that for 28 days in the observation period of Study 231 [responder]. If the reduction in seizure frequency is less than 50%, then the participants are considered as non-responders.
LOCF = Last Observation Carried Forward.
Measured: Week 1 through Week 316 and Follow-up period of the Extension study, up to approximately 7 years 2 months
The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment
Each participant evaluated him/herself for PGIC at Week 52 of the Treatment Period and at the end of treatment (or discontinuation) by comparing seizure conditions during 4 weeks before Week 52 of the Treatment Period and those during 4 weeks before end of treatment (or discontinuation) of the open label extension study with those during 4 weeks before start of the Treatment Period of Study 231. Assessment was implemented based on frequency of seizure, severity of seizures, AEs, and overall conditions using the 7-grade scores. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse.
Measured: Week 52 and End of Treatment; up to approximately 7 years 2 months
The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment
The investigator evaluated each participant for CGIC at Week 52 of the Treatment Period and at the end of treatment (or discontinuation) by comparing medical conditions during 4 weeks before Week 52 of the Treatment Period and those during 4 weeks before end of treatment (or discontinuation) of the open label extension study with those during 4 weeks before start of the Treatment Period of Study 231. Assessment was implemented based on frequency of seizure, severity of seizures, AEs, and overall conditions using the 7-grade scores. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse.
Measured: Week 52 and End of Treatment, up to approximately 7 years 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study start17 Jun 2009
- Primary completion8 Aug 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory Partial 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kazunori Saeki, Study director, Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903786
- Sponsor's protocol ID
- E2007-J081-233
- Status last verified
- Sep 2017
- First submitted
- 15 May 2009
- Last updated
- 29 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
- ClinicalTrials.gov ID
- NCT00903786
- Acronym / sponsor ID
- E2007-J081-233
- Conditions
- Refractory Partial Seizures
- Keywords
- Seizure, epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2009 (actual)
- Primary completion
- 8 Aug 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 18 May 2009 (estimated)
- Results
- Posted 29 Aug 2018
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 trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perampanel | Experimental | Drug: perampanelParticipants were treated with the perampanel dose that was administered in maintenance period of Study E2007-J081-231 (Study 231) [NCT00849212]. In some instances, a 1-step down-titration from the viewpoint of safety and up-titration to the maintenance dose of Study 231 was allowed. In general, 1 to 6 tablets of perampanel was administered orally as a 2-milligram (mg) tablet (2 mg to 12 mg) once daily before bedtime (under fed conditions as much as possible). The investigator, or subinvestigator, was allowed to complete the treatment by tapering the study drug after end of treatment or discontinuation (Follow-up Period), as appropriate. The taper period was 4 weeks at the longest. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who consent to the study entry on their free will before starting any trial-related activities.
- Patients who participated in Study 231 and completed the required evaluation period (10 weeks).
- Patients who are certainly and voluntarily able to participate in this study and record their seizures by themselves or have family members or caregivers (or nurses, if hospitalized) record the seizures. Patients who wish to continue perampanel treatment and necessitate receiving the long- term administration judged by the investigator or sub-investigator.
Key exclusion criteria (4 listed)
- Pregnant or lactating women, women of child-bearing potential, women willing to become pregnant.
- Patients who are ineligible judged by the investigator or sub investigator in light of medical history or complication at enrollment in treatment period.
- Patients who operate heavy equipment or drive should not be recruited into the study.
- Patients who are ineligible for study entry judged by the investigator or sub-investigator.
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, FycompaPatients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231. | Drug | Perampanel |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
Time frame: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 7 years 2 months
Safety was assessed by monitoring adverse events (AEs), adverse drug reactions, clinical laboratory parameters, vital signs, 12-lead electrocardiogram, and dependency questionnaire. AEs were graded on a 3-point scale; 1) mild: (Grade 1) discomfort noticed, but no disruption of normal daily activity, 2) moderate: (Grade 2) discomfort reduced or affected normal daily activity, and 3) severe: (Grade 3) incapacitating, with inability to work or to perform normal daily activity. AE severity associated with abnormal changes in laboratory parameters was assessed using the Ministry of Health and Welfare Notification Number 80 "Classification of Severity of Adverse Drug Reactions of Medicinal Products". TEAEs were defined as AEs that emerged during treatment (absent at pretreatment [Baseline]), reemerged during treatment (were present at pretreatment but stopped before treatment), or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.
4 secondary outcomes
Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316
Time frame: From Week 1 through Week 316 and Follow-up Period of the Extension Study, up to approximately 7 years 2 months
Responder Rate During the Treatment Period-LOCF
Time frame: Week 1 through Week 316 and Follow-up period of the Extension study, up to approximately 7 years 2 months
The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment
Time frame: Week 52 and End of Treatment; up to approximately 7 years 2 months
The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment
Time frame: Week 52 and End of Treatment, up to approximately 7 years 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kazunori Saeki study director
Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing perampanel in people with Refractory Partial Seizures, run by Eisai Co., Ltd. at 9 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 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel (time frame: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 7 years 2 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 29 Aug 2018.