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

NCT00849212 | Completed Phase 2 Results

• 1 other identifier: E2007-J081-231
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 9

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

Keywords

Seizures; epilepsy

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks (Titration and Maintenance Periods)

Secondary Outcomes (1)

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

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

Study Arms (1)

1

EXPERIMENTAL

Drug: E2007

Interventions

E2007 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.

1

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (9)

Unknown Facility

Kitakyushu, Fukuoka, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Kyoto, Kyoto, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

Unknown Facility

Nagasaki, Nagasaki, Japan

Location

Unknown Facility

Niigata, Niigata, Japan

Location

Unknown Facility

Shizuoka, Shizuoka, Japan

Location

Unknown Facility

Komatsushimachō, Tokushima, Japan

Location

Unknown Facility

Kodaira, Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 35305920 DERIVED

MeSH Terms

Conditions

Seizures; Epilepsy

Interventions

perampanel

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Hidetaka Hiramatsu

  New Drug Development Department, Eisai Company Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 23, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 7, 2013
• Results First Posted: February 7, 2013

Record last verified: 2013-01

Locations

JP (9)