A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)

NCT01146951 | Completed Phase 3 Results

• 1 other identifier: E2080-J081-304
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 23

Brief Summary

To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.

Conditions

Lennox-Gastaut Syndrome

Keywords

Epilepsy; Seizures

Outcome Measures

Primary Outcomes (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" and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period 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.

  Baseline (28 day observational period) and End of Treatment (28 day treatment period)

Secondary Outcomes (4)

• Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency

  12 weeks

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

  Baseline (28 day observational period) and End of Treatment (28 day treatment period)

• Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days)

  Baseline (28 day observational period) and End of Treatment (28 day treatment period)

• Clinical Global Impression of Change (CGIC)

  Up to Week 12 of the treatment period

Study Arms (2)

Rufinamide (E2080)

EXPERIMENTAL

Drug: Rufinamide (E2080)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rufinamide (E2080) DRUG

Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)

Also known as: E2080

Rufinamide (E2080)

Placebo DRUG

Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.

Placebo

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 are diagnosed as Lennox-Gastaut syndrome with tonic/atonic seizures and atypical absence seizures (A history of atypical absence seizures will also be incorporated).
• Participants who had a slow spike-and-wave pattern in an electroencephalogram within 6 months prior to the enrollment for the Observation Period.
• Participants who had at least a total of 90 seizures in the 28 days prior to the enrollment for the Observation Period.
• Participants who have been on 1 - 3 anti-epileptic drugs from 28 days prior to the enrollment for the Observation Period and have not changed the type of the anti-epileptic drugs.
• Participants who have not changed the type nor the dose or administration of the anti-epileptic drugs they are taking in the Observation Period.

You may not qualify if:

• Participants who had a history of generalized tonic-clonic status epilepticus within baseline.
• Participants who received drug therapy at least 4 times to be rescued from status epilepticus within baseline.
• Participants who had a history of hypoxia which needed emergency resuscitation within 12 months prior to the Treatment Period.
• Participants who were on a ketogenic diet or have received adrenocorticotropic hormone (ACTH) therapy or Vitamin B6 therapy within 6 months prior to the Treatment Period.
• Participants who had a history of suicide attempt within the 1 year prior to the Treatment Period.
• Participants who had a history of or has an allergy to triazole compound.
• Participants who have clinically significant electrocardiogram abnormalities at baseline.
• Participants who are pregnant, who may be pregnant, who are lactating or who wish to be pregnant.

Sponsors & Collaborators

• Eisai Limited: 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

Iwamuma-shi, Miyagi, Japan

Location

Unknown Facility

Omura-shi, 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

Okayama, Okayama-ken, Japan

Location

Unknown Facility

Neyagawa, Osaka, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

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Unknown Facility

Suita-shi, Osaka, Japan

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Unknown Facility

Moriya-shi, Shiga, Japan

Location

Unknown Facility

Shizuoka, Shizuoka, Japan

Location

Unknown Facility

Kodaira-shi, Tokyo, Japan

Location

Unknown Facility

Kokubunji-shi, Tokyo, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, Japan

Location

Unknown Facility

Toyoma-shi, Toyama, Japan

Location

Related Publications (2)

• Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.

  PMID: 33825230 DERIVED

• Panebianco M, Prabhakar H, Marson AG. Rufinamide add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Nov 8;11(11):CD011772. doi: 10.1002/14651858.CD011772.pub3.

  PMID: 33179247 DERIVED

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: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 24, 2018
• Results First Posted: November 21, 2013

Record last verified: 2018-01

Locations

JP (23)