A Long Term Extension Study of E2080 in Lennox-Gastaut Patients

NCT01151540 | Completed Phase 3 Results

• 1 other identifier: E2080-J081-305
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 23

Brief Summary

To investigate the safety of long term administration of E2080 in the patients with Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.

Conditions

Lennox-Gastaut Syndrome

Keywords

Epilepsy; Seizures

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide

  Safety was assessed by monitoring and recording all adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, blood pressure, pulse rate, physical examination, and 12-lead electrocardiogram (ECG). Treatment-emergent adverse events (TEAEs) were defined as AEs that started on or after the date and time of administration of first dose of test drug, but not later than 30 days after discontinuation from the study, or if the AE was present prior to the administration of the first dose of test drug and increased in National Cancer Institute Common Toxicity Criteria (NCI CTC version 3.0) grade during the study or 30 days after discontinuation from the study. AEs were considered serious if it resulted in; death, was life-threatening, hospitalization/prolonged hospitalization, persistent or significant disability/incapacity, or a congenital anomaly/birth defect.

  From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 years 10 months

Secondary Outcomes (5)

• Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)

  Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF

• Percent Change in the Total Seizure Frequency From Baseline (Per 28 Days)

  Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF

• Percent Change in the Frequency of Seizures Other Than Tonic-Atonic Seizures

  Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF

• Percentage of Participants Who Achieved 100%, 75%, 50% or 25% Reduction in Tonic-Atonic Seizure Frequency (Responders)

  Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF

• Percentage of Participants With An Increase In Tonic-Atonic Seizure Frequency

  Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF

Study Arms (1)

Rufinamide

EXPERIMENTAL

Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period.

Drug: Rufinamide

Interventions

Rufinamide DRUG

The target dosage is approximately 45 mg/kg/day, taken orally twice a day.

Also known as: E2080, BANZEL

Rufinamide

Eligibility Criteria

• Age: 4 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants who have completed the evaluation of Week 12 of the E2080-J081-304 study.
• Male participants with reproductive ability and female participants with child-bearing potential, or their partners, had to be able to take medically appropriate contraceptive measures.
• Participants who have provided a written informed consent to participate in this clinical trial until the evaluation of week 12 of the E2080-J081-304 study.
• Participants who had a family member or a caregiver capable of recording the reporting diary, providing participant information necessary for the study, assisting treatment compliance, and accompanying the participant on scheduled visit days during the study period.

You may not qualify if:

• Participants who were judged by the investigator that they are unfit to participate in this clinical study for safety reasons based on the information up to the evaluation of week 12 of the E2080-J081-304 Study.
• Participants who were judged by the investigator that they are likely to become non-compliant with administration during the clinical trial period.
• Participants who were judged by the investigator that they were unfit to participate in this clinical trial.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (23)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Matsuyama, Ehime, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Goshi^shi, Kumamoto, Japan

Location

Unknown Facility

Iwanuma-shi, Miyagi, Japan

Location

Unknown Facility

Ōmura, Nagasaki, Japan

Location

Unknown Facility

Nara, Nara, Japan

Location

Unknown Facility

Niigata, Niigata, Japan

Location

Unknown Facility

Yufu-shi, Oita Prefecture, Japan

Location

Unknown Facility

Neyagawa, Osaka, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Suita-shi, Osaka, Japan

Location

Unknown Facility

Moriyama-shi, Shiga, Japan

Location

Unknown Facility

Shizuoka, Shizuoka, Japan

Location

Unknown Facility

Kodaira, Tokyo, Japan

Location

Unknown Facility

Kokubunji-shi, Tokyo, Japan

Location

Unknown Facility

Shinjuku, Tokyo, Japan

Location

Unknown Facility

Toyoma-shi, Toyama, Japan

Location

Unknown Facility

Okayama, Japan

Location

MeSH Terms

Conditions

Lennox Gastaut Syndrome; Epilepsy; Seizures

Interventions

rufinamide

Condition Hierarchy (Ancestors)

Epileptic Syndromes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Customer Joy Department. EJ
• Organization: Eisai Co., Ltd.

_ML_CLNCL@hhc.eisai.co.jp

8133817-3700

Study Officials

• Hiroki Takano

  Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 28, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 11, 2019
• Results First Posted: March 11, 2019

Record last verified: 2018-03

Locations

JP (23)