Phase 3
N=59
A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
Lennox-Gastaut Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01146951 ↗Enrolled (actual)
59
Serious AEs
3.4%
Results posted
Nov 2013
Primary outcome: Primary: Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) — -24.20; -3.25 Percent Change — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rufinamide (E2080) (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Eisai Limited
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) |
-24.20; -3.25 | 0.003 sig |
| SECONDARY Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency |
7; 2; 21; 28 | 0.074 |
| SECONDARY Percent Change in Total Seizure Frequency (Per 28 Days) |
-32.90; -3.05 | <0.001 sig |
| SECONDARY Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) |
-52.20; 4.5; 3.40; NA; -59.00; -21.10 | 0.025 sig |
| SECONDARY Clinical Global Impression of Change (CGIC) |
0; 0; 9; 0; 4; 9 | 0.041 sig |
Summary
To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.
Eligibility Criteria
Inclusion criteria
- 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.
Exclusion criteria;
- 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.
Data sourced from ClinicalTrials.gov (NCT01146951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.