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

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ClinicalTrials.gov Identifier: NCT01151540
Recruitment Status : Completed
First Posted : June 28, 2010
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
Lennox-Gastaut Syndrome Drug: Rufinamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
Actual Study Start Date : November 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013


Arm Intervention/treatment
Experimental: Rufinamide
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
The target dosage is approximately 45 mg/kg/day, taken orally twice a day.
Other Name: E2080, BANZEL




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 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].

  3. 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 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.

  4. 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 ]
    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.

  5. 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 ]
    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.



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Ages Eligible for Study:   4 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151540


Locations
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Japan
Nagoyashi, Aichi, Japan
Matsuyama, Ehime, Japan
Fukuoka-shi, Fukuoka, Japan
Hiroshima-shi, Hiroshima, Japan
Sapporo-shi, Hokkaido, Japan
Kobe-shi, Hyogo, Japan
Yokohama, Kanagawa, Japan
Goshi^shi, Kumamoto, Japan
Iwanuma-shi, Miyagi, Japan
Omura, Nagasaki, Japan
Nara-shi, Nara, Japan
Niigata-shi, Niigata, Japan
Yufu-shi, Oita, Japan
Neyagawa-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Moriyama-shi, Shiga, Japan
Shizuoka-shi, Shizuoka, Japan
Kodaira, Tokyo, Japan
Kokubunji-shi, Tokyo, Japan
Shinjuku, Tokyo, Japan
Toyoma-shi, Toyama, Japan
Okayama, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Study Director: Hiroki Takano Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01151540     History of Changes
Other Study ID Numbers: E2080-J081-305
First Posted: June 28, 2010    Key Record Dates
Results First Posted: March 11, 2019
Last Update Posted: March 11, 2019
Last Verified: March 2018
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Epilepsy
Seizures
Additional relevant MeSH terms:
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Lennox Gastaut Syndrome
Epileptic Syndromes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Rufinamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action