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

Primary Purpose

Refractory Partial Seizures

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

E2007

About this trial

This is an interventional treatment trial for Refractory Partial Seizures focused on measuring Seizures, epilepsy

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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:
- Carbamazepine
- Phenytoin
- Phenobarbital
- Primidone
Patients on stable dose of anti-depressants, anti-anxiety drugs, or mood stabilizers from before 8 weeks.

Exclusion criteria:

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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00849212

First Posted

February 20, 2009

Last Updated

January 3, 2013

Sponsor

Eisai Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00849212

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Partial Seizures

Keywords

Seizures, epilepsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

E2007

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose (MTD)

Description

Time Frame

10 weeks (Titration and Maintenance Periods)

Secondary Outcome Measure Information:

Title

Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF

Description

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.

Time Frame

Baseline (Day -28 to Day 0), Week 1 to Week 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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: Carbamazepine Phenytoin Phenobarbital Primidone Patients on stable dose of anti-depressants, anti-anxiety drugs, or mood stabilizers from before 8 weeks. Exclusion criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hidetaka Hiramatsu

Organizational Affiliation

New Drug Development Department, Eisai Company Limited

Official's Role

Study Director

Facility Information:

City

Kitakyushu

State/Province

Fukuoka

Country

Japan

City

Kobe

State/Province

Hyogo

Country

Japan

City

Sendai

State/Province

Miyagi

Country

Japan

City

Komatsushima

State/Province

Tokushima

Country

Japan

City

Kodaira

State/Province

Tokyo

Country

Japan

City

Kyoto

Country

Japan

City

Nagasaki

Country

Japan

City

Niigata

Country

Japan

City

Shizuoka

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

35305920

Citation

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.

Results Reference

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

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