An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)

NCT ID: NCT00849212

Last Updated: 2013-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-11-30

Brief 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). 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

E2007

Intervention Type: DRUG

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.

Interventions

E2007

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female aged between 20 and 64 years old.

2. Patients diagnosed with partial seizure (including secondarily generalized seizure).

3. 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.

4. Patients who have been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard AED for 2 years.

5. 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:

• Carbamazepine
• Phenytoin
• Phenobarbital
• Primidone

6. Patients on stable dose of anti-depressants, anti-anxiety drugs, or mood stabilizers from before 8 weeks.

Exclusion Criteria

1. Patients with present or a history of Lennox-Gastaut syndrome.

2. Patients with present generalized seizures (e.g., absence, myoclonic).

3. Patients with a history of status epilepticus within 1 year.

4. Patients with seizure clusters where individual seizure cannot be counted within 8 weeks.

5. Patients with a history of psychogenic seizure.

6. Patients who underwent surgical operation for epilepsy within 2 years.

7. 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).

8. 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.

9. Patients with significant active hematological disease; white blood cell (WBC) count </=2500/uL or neutrophil count </=1000 uL.

10. 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.

11. Patients who operate heavy equipment or drive should not be recruited into the study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hidetaka Hiramatsu

Role: STUDY_DIRECTOR

New Drug Development Department, Eisai Company Limited

Locations

Kitakyushu, Fukuoka, Japan

Kobe, Hyōgo, Japan

Kyoto, Kyoto, Japan

Sendai, Miyagi, Japan

Nagasaki, Nagasaki, Japan

Niigata, Niigata, Japan

Shizuoka, Shizuoka, Japan

Komatsushimachō, Tokushima, Japan

Kodaira, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 35305920 (View on PubMed)

Other Identifiers

E2007-J081-231

Identifier Type: -

Identifier Source: org_study_id