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Lennox-Gastaut SyndromePhase 3NCT01151540

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

A Phase 3 study testing Rufinamide in people with Lennox-Gastaut Syndrome, run by Eisai Co., Ltd. at 23 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 30 years
Conditions the study is for
Lennox-Gastaut Syndrome
What is being tested?
Rufinamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
23 sitesJapan
Study dates
Nov 2010to Aug 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Japan23 sites

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Goshi^shi, Kumamoto

  • Study site

    Hiroshima, Hiroshima

  • Study site

    Iwanuma-shi, Miyagi

  • Study site

    Kobe, Hyōgo

  • Study site

    Kodaira, Tokyo

  • Study site

    Kokubunji-shi, Tokyo

  • Study site

    Matsuyama, Ehime

  • Study site

    Moriyama-shi, Shiga

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nara, Nara

  • Study site

    Neyagawa, Osaka

  • Study site

    Niigata, Niigata

  • Study site

    Okayama

  • Study site

    Ōmura, Nagasaki

  • Study site

    Osaka, Osaka

  • Study site

    Sapporo, Hokkaido

  • Study site

    Shinjuku, Tokyo

  • Study site

    Shizuoka, Shizuoka

  • Study site

    Suita-shi, Osaka

  • Study site

    Toyoma-shi, Toyama

  • Study site

    Yokohama, Kanagawa

  • Study site

    Yufu-shi, Oita Prefecture

Other trials in Japan

About this study

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

Being tested
Rufinamide
Keywords
Epilepsy, Seizures
Medical subject headings
Lennox Gastaut Syndrome, Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RufinamideDrug

    Also called E2080, BANZEL

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

Study groups in NCT01151540
Study groupRoleWhat they receive
RufinamideExperimentalRalfinamide 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.
Receives: Drug: Rufinamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

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

    The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency". The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period in Study 304 as the baseline and the tonic-atonic seizure frequency at Weeks 12, 24, 32, 40, 52 and Week 52 Last Observation Carried Forward (LOCF) as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period.

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

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

    Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period of Study 304 as the baseline and the total seizure frequency per 28 days at Weeks 12, 24, 32, 40, 52 and Week 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].

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

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

    Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Weeks, 12, 24, 32, 40, 52 and 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. Seizures analyzed other than tonic-atonic seizures included: Partial seizure frequency, Absence seizure, Atypical absence seizure, Myoclonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, and Unclassified epileptic seizure. This data was based on the diary data collected for 7 days after each visit. Seizure frequency was counted based on the classification established by the ILAE. The diary recorder monitored the participant and recorded the seizure diary in a consistent manner.

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

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

    Categorized percent change in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used.

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

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

    Number of participants with an increase in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01151540
Sponsor's protocol ID
E2080-J081-305
Status last verified
Mar 2018
First submitted
14 Jun 2010
Last updated
11 Mar 2019

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rufinamide in people with Lennox-Gastaut Syndrome, run by Eisai Co., Ltd. at 23 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01151540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.

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