A global study completed at hospitals in US, Europe & Asia using an investigational drug (Perampanel) to research its safety & effectiveness in patients who are at least 2 years of age with Lennox-Gastaut Syndrome

Phase 1

• Conditions: Seizures associated with Lennox-Gastaut Syndrome (LGS); MedDRA version: 20.0Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-002321-35-PL
• Lead Sponsor: Eisai Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-13
• Study Completion: 2021-07-19
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Subjects must meet all of the following criteria to be included in this study:
1. Subjects must have diagnosis of LGS as evidenced by:
a. More than one type of generalized seizures, including drop seizures (atonic, tonic, or myoclonic) for at least 6 months before Visit 1
b. An EEG reporting diagnostic criteria for LGS at some point in their history (abnormal background activity accompanied by slow, spike and wave pattern <2.5 Hz)
2. Subjects must be at least 2 years old at the time of consent.
3. Subjects must have been <11 years old at the onset of LGS.
4. Subjects must have experienced at least 2 drop seizures per week in the 4 -week Baseline Period preceding randomization; the Baseline Period within the Prerandomization Phase is 4 weeks.
5. Subjects must have been receiving 1 to 3 concomitant AEDs at a stable dose for at least 30 days before Visit 1 (vagal nerve stimulation [VNS] and ketogenic diet do not count as an AED).
6. In the investigator’s opinion, parents or caregivers must be able to keep accurate seizure diaries.
7. Body weight at least 8 kg
Are the trial subjects under 18? yes
Number of subjects for this age range: 135
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1. Presence of progressive neurological disease
2. Presence of drop seizure clusters where individual seizures cannot be reliably counted
3. Prior treatment with perampanel with discontinuation due to safety issues (related to perampanel)
4. Prior treatment with perampanel must have been discontinued at least 30 days before Visit 1
5. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject’s safety or study conduct
6. Scheduled for epilepsy-related surgery or any other form of surgery during the projected course of the study
7. Ketogenic diet and VNS, unless stable and ongoing for at least 30 days before Visit 1
8. Treatment with an investigational drug or device in the 30 days before Visit 1
9. Status epilepticus within 12 weeks of Visit 1
10. If felbamate is used as a concomitant AED, subjects must be on felbamate for at least one year, with a stable dose for 60 days before Visit 1. They must not have an indication of hepatic or bone marrow dysfunction while receiving felbamate.
11. Concomitant use of vigabatrin: Subjects who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1, and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test
12. Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions
13. Evidence of significant active hepatic disease. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are < 3 times the ULN
14. Adrenocorticotropic hormone within the 6 months before Visit 1
15. Had history of anoxic episodes requiring resuscitation within 6 months before Visit 1
16. Females who are breastfeeding or pregnant at Screening or Baseline. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
17. Females of childbearing potential who:
Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
o Total abstinence
o An intrauterine device or intrauterine hormone-releasing system (IUS)
o An oral contraceptive
o Have a vasectomized partner with confirmed azoospermia.
Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation.
18. Had intermittent use of benzodiazepine of more than 4 single administrations in the month before Visit 1
19. A prolonged QT/QTc interval as demonstrated by a repeated electrocardiogram (ECG)
20. Hypersensitivity to the study drug or any of the excipients
21. Any history of a medical condition or a concomitant medical condition that in the opinion of the investigator(s) would compromise the subject’s ability to safely complete the study
22. Known to be human immunodeficiency virus (HIV) positive
23. Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
24. Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics or prior suicide attempt(s) within approximately the last 2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified