Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy
NCT ID: NCT03780907
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2003-02-14
2003-08-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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E2007 1 mg
Tablet, once daily to be taken in the morning by mouth, one hour before breakfast, with a glass of water.
E2007
1 mg of E2007 was administered by mouth once daily.
E2007 2 mg
Tablet, once daily to be taken in the morning by mouth, one hour before breakfast, with a glass of water.
E2007
2 mg of E2007 was administered by mouth once daily.
Placebo
Tablet, once daily to be taken in the morning, one hour before breakfast, with a glass of water.
Placebo
Placebo once daily of oral tablet formulation to be taken in the morning, one hour before breakfast, with a glass of water.
Interventions
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E2007
1 mg of E2007 was administered by mouth once daily.
E2007
2 mg of E2007 was administered by mouth once daily.
Placebo
Placebo once daily of oral tablet formulation to be taken in the morning, one hour before breakfast, with a glass of water.
Eligibility Criteria
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Inclusion Criteria
2. Age: 18 to 65 years.
3. Race: any.
4. Patients receiving up to two additional anti-epileptic medications at doses that were stable for at least the four weeks immediately preceding baseline.
5. Patients willing and able to co-operate with the study procedures including completion of patient diaries.
6. Patients living at home with a partner or carer able to monitor compliance.
7. Patients giving informed consent to participate in the study.
Exclusion Criteria
2. Women of childbearing potential unless (1) surgically sterile or (2) practicing effective contraception (eg, abstinence, IUD or barrier method plus hormonal method) and having a negative serum beta-HCG result at screening and being willing to remain on the current form of contraception for the duration of the study. Postmenopausal women could be included but were to have been amenorrhoeic for at least 12 months to be considered as not being of child-bearing potential.
3. Fertile men not willing to use reliable contraception or with partners not willing to use reliable contraception.
4. Patients with status epilepticus within the past 24 months.
5. Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, abdominal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
6. Patients with significantly elevated liver enzymes (abnormal bilirubin level, or serum transaminase levels more than 1.5 times the upper limit of normal).
7. Patients taking drugs other than anti-epileptic agents which induce the enzyme cytochrome P450 3A4 (since these might reduce the plasma concentration of E2007), including dexamethasone, rifabutin, rifampacin, St John's Wort.
8. Patients with past or present drug or alcohol abuse.
9. Patients with unstable psychiatric illness.
10. Patients who had received an investigational drug within the three months before baseline.
11. Patients without a reliable partner or carer.
12. Patients with any condition which would make the patient, in the opinion of the investigator, unsuitable for the study.
18 Years
65 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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3ClinicalResearch AG
Hennigsdorf, , Germany
Countries
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References
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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.
Other Identifiers
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E2007-E049-203
Identifier Type: -
Identifier Source: org_study_id