Refractory Partial SeizuresPhase 2NCT00849212
An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
A Phase 2 study testing E2007 in people with Refractory Partial Seizures, run by Eisai Co., Ltd. at 9 sites in Japan.
Trial summary
The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per day). 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?
- E2007
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesJapan
- Study dates
- Apr 2009to Nov 2009
- 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
- Male or female aged between 20 and 64 years old.
- Patients diagnosed with partial seizure (including secondarily generalized seizure).
- Patients who have at least 3 counts of partial seizures during the previous 4 weeks prior to observation start and no seizure-free for 21 days during 8 weeks before the treatment start based on medical records. Simple partial seizure without motor signs will not be counted.
- Patients who have been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard AED for 2 years.
- Patients treated with stable doses of up to three AEDs. Only one cytochrome
- P450 (CYP) 3A4 inducer shown below will be allowed for concomitant use:
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- Carbamazepine
- Phenytoin
- Phenobarbital
- Primidone
- Patients on stable dose of anti-depressants, anti-anxiety drugs, or mood stabilizers from before 8 weeks.
Who cannot join
- Patients with present or a history of Lennox-Gastaut syndrome.
- Patients with present generalized seizures (e.g., absence, myoclonic).
- Patients with a history of status epilepticus within 1 year.
- Patients with seizure clusters where individual seizure cannot be counted within 8 weeks.
- Patients with a history of psychogenic seizure.
- Patients who underwent surgical operation for epilepsy within 2 years.
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- Patients using rescue benzodiazepines at least twice in a 4-week duration within 8 weeks (if 1 or 2 doses over 24-hour period considered one-time rescue).
- Patients whose alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at enrollment in observation period exceeds 1.5-fold the upper limit of normal (ULN), but those whose ALT or AST are constantly higher than ULN, they can enroll if ALT or AST remain in 3-fold the ULN.
- Patients with significant active hematological disease; white blood cell (WBC) count </=2500/uL or neutrophil count </=1000 uL.
- Patients on anti-psychotics or who have psychotic disorder and/or psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of suicidal attempt within 2 years.
- Patients who operate heavy equipment or drive should not be recruited into the study.
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, Kyoto
Study site
Nagasaki, Nagasaki
Study site
Niigata, Niigata
Study site
Sendai, Miyagi
Study site
Shizuoka, Shizuoka
About this study
Official title: A Phase II, Open-label, Ascending High-dose, add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per day). The dose of E2007 will be adjusted during 6 weeks. Subsequently, the dose will be fixed and maintained during 4 weeks.
- Conditions
- Refractory Partial Seizures
- Being tested
- E2007
- Keywords
- Seizures, 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.
E2007Drug
The dose of E2007 will start from 2 mg and will be increased by 2 mg every week up to 12 mg (the maximum dose). The dose will be adjusted during 6 weeks (i.e., titration period). Subsequently, the dose will be fixed and maintained during 4 weeks (Maintenance period). Patients must visit study site at Weeks -4, 1, 2, 3, 4, 5, 6, 8, 10 and 14 to confirm.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E2007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
MTD was defined by participants. For participants who completed treatment, MTD was dose at last administration. For subjects who discontinued due to adverse event (AE), the MTD depended on the number of days within down-titration. If these criteria were not applied, the MTD was determined based on suggestions from the Tolerability and Safety Evaluation Committee.
Measured: 10 weeks (Titration and Maintenance Periods)
Secondary outcomes (1)
Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF
The percent change in seizure frequency per 28 days during the maintenance period was collected via patient diary cards. This was calculated using the last observation carried forward (LOCF) method.
Measured: Baseline (Day -28 to Day 0), Week 1 to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionNov 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hidetaka Hiramatsu, Study director, New Drug Development Department, Eisai Company Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849212
- Sponsor's protocol ID
- E2007-J081-231
- Status last verified
- Jan 2013
- First submitted
- 20 Feb 2009
- Last updated
- 7 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
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 35305920
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Ascending High-dose, add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
- ClinicalTrials.gov ID
- NCT00849212
- Acronym / sponsor ID
- E2007-J081-231
- Conditions
- Refractory Partial Seizures
- Keywords
- Seizures, epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 23 Feb 2009 (estimated)
- Results
- Posted 7 Feb 2013
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 explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per day). The dose of E2007 will be adjusted during 6 weeks. Subsequently, the dose will be fixed and maintained during 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E2007 |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female aged between 20 and 64 years old.
- Patients diagnosed with partial seizure (including secondarily generalized seizure).
- Patients who have at least 3 counts of partial seizures during the previous 4 weeks prior to observation start and no seizure-free for 21 days during 8 weeks before the treatment start based on medical records. Simple partial seizure without motor signs will not be counted.
- Patients who have been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard AED for 2 years.
- Patients treated with stable doses of up to three AEDs. Only one cytochrome
Key exclusion criteria (11 listed)
- Patients with present or a history of Lennox-Gastaut syndrome.
- Patients with present generalized seizures (e.g., absence, myoclonic).
- Patients with a history of status epilepticus within 1 year.
- Patients with seizure clusters where individual seizure cannot be counted within 8 weeks.
- Patients with a history of psychogenic seizure.
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 |
|---|---|---|
| E2007The dose of E2007 will start from 2 mg and will be increased by 2 mg every week up to 12 mg (the maximum dose). The dose will be adjusted during 6 weeks (i.e., titration period). Subsequently, the dose will be fixed and maintained during 4 weeks (Maintenance period). Patients must visit study site at Weeks -4, 1, 2, 3, 4, 5, 6, 8, 10 and 14 to confirm. | Drug | 1 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 10 weeks (Titration and Maintenance Periods)
MTD was defined by participants. For participants who completed treatment, MTD was dose at last administration. For subjects who discontinued due to adverse event (AE), the MTD depended on the number of days within down-titration. If these criteria were not applied, the MTD was determined based on suggestions from the Tolerability and Safety Evaluation Committee.
1 secondary outcome
Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF
Time frame: Baseline (Day -28 to Day 0), Week 1 to Week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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.
Hidetaka Hiramatsu study director
New Drug Development Department, Eisai Company Limited
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 E2007 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 11 inclusion and 11 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 Feb 2013. 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 7 Feb 2013). 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?
Maximum Tolerated Dose (MTD) (time frame: 10 weeks (Titration and Maintenance Periods)). 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 NCT00849212, 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 7 Feb 2013.