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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01151540
• Date of registration: 14/06/2010
• Prospective Registration: Yes
• Primary sponsor: Eisai Co., Ltd.
• Public title: A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
• Scientific title: A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
• Date of first enrolment: November 2010
• Target sample size: 54
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01151540
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Hiroki Takano
• Affiliation: Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:

1. Participants who have completed the evaluation of Week 12 of the E2080-J081-304 study.

2. 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.

3. 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.

4. 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.

Exclusion criteria:

1. 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.

2. Participants who were judged by the investigator that they are likely to become
non-compliant with administration during the clinical trial period.

3. Participants who were judged by the investigator that they were unfit to participate
in this clinical trial.



Age minimum: 4 Years
Age maximum: 30 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lennox-Gastaut Syndrome

Intervention(s)

Drug: Rufinamide

Primary Outcome(s)

Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide [Time Frame: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 years 10 months]

Secondary Outcome(s)

Percentage of Participants Who Achieved 100%, 75%, 50% or 25% Reduction in Tonic-Atonic Seizure Frequency (Responders) [Time Frame: 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 [Time Frame: 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) [Time Frame: Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF]

Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) [Time Frame: Baseline (Observation period in Study 304), 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 [Time Frame: Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF]

Secondary ID(s)

E2080-J081-305

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01151540