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

NCT ID: NCT01146951

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rufinamide (E2080)

Group Type: EXPERIMENTAL

Rufinamide (E2080)

Intervention Type: 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)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Rufinamide (E2080)

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)

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

E2080

Eligibility Criteria

Inclusion Criteria

1. 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).

2. Participants who had a slow spike-and-wave pattern in an electroencephalogram within 6 months prior to the enrollment for the Observation Period.

3. Participants who had at least a total of 90 seizures in the 28 days prior to the enrollment for the Observation Period.

4. 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.

5. Participants who have not changed the type nor the dose or administration of the anti-epileptic drugs they are taking in the Observation Period.

Exclusion Criteria

1. Participants who had a history of generalized tonic-clonic status epilepticus within baseline.

2. Participants who received drug therapy at least 4 times to be rescued from status epilepticus within baseline.

3. Participants who had a history of hypoxia which needed emergency resuscitation within 12 months prior to the Treatment Period.

4. 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.

5. Participants who had a history of suicide attempt within the 1 year prior to the Treatment Period.

6. Participants who had a history of or has an allergy to triazole compound.

7. Participants who have clinically significant electrocardiogram abnormalities at baseline.

8. Participants who are pregnant, who may be pregnant, who are lactating or who wish to be pregnant.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroki Takano

Role: STUDY_DIRECTOR

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

Locations

Nagoya, Aichi-ken, Japan

Matsuyama, Ehime, Japan

Fukuoka, Fukuoka, Japan

Hiroshima, Hiroshima, Japan

Sapporo, Hokkaido, Japan

Kobe, Hyōgo, Japan

Yokohama, Kanagawa, Japan

Goshi-shi, Kumamoto, Japan

Iwamuma-shi, Miyagi, Japan

Omura-shi, Nagasaki, Japan

Nara, Nara, Japan

Niigata, Niigata, Japan

Yufu-shi, Oita Prefecture, Japan

Okayama, Okayama-ken, Japan

Neyagawa, Osaka, Japan

Osaka, Osaka, Japan

Suita-shi, Osaka, Japan

Moriya-shi, Shiga, Japan

Shizuoka, Shizuoka, Japan

Kodaira-shi, Tokyo, Japan

Kokubunji-shi, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Toyoma-shi, Toyama, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 33825230 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33179247 (View on PubMed)

Other Identifiers

E2080-J081-304

Identifier Type: -

Identifier Source: org_study_id