ot applicable

Phase 1

• Conditions: epilepsy; MedDRA version: 18.0Level: LLTClassification code 10015052Term: Epileptic seizureSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-001318-32-HU
• Lead Sponsor: psher-Smith Laboratories, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-11
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

•Subject or subject's legally acceptable representative (LAR) has provided written informed consent, and subject has provided written assent where required by local law or Institutional Review Board/Independent Ethics Committee policy
•Subject has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
•Subject is 12 years of age or older, at Visit 1
•Subject has an established diagnosis of partial or generalized epilepsy that includes all of the following:
- A documented history of seizure clusters lasting a minimum of 10 minutes from the time the seizure cluster is recognized
- The seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any) in seizure type, duration, severity or frequency
- As part of the subject's stereotyped seizure cluster pattern, a second seizure typically occurs within 6 hours from the time of recognition of the seizure cluster
- In the investigator's opinion, it would be safe for the subject to receive placebo as a first dose of study drug followed by active treatment (USL261) as the second dose of study drug no earlier than 10 minutes after the first dose
- The subject's stereotyped seizure cluster pattern is composed of multiple (=2) partial or generalized seizures
- The subject's stereotyped seizure cluster pattern was established > 3 months before Visit 1
- A frequency of =3 stereotyped seizure clusters during the year before Visit 1
- At least 1 stereotyped seizure cluster occurring =4 months before Visit 1
- The seizure cluster pattern described above is confirmed by a central reviewer
•Currently on a stable regimen of AEDs since Visit 1 and for =7 days before Visit 2.

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 283
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

•Subject has a neurological disorder that is likely to progress in the next year
•Subject has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
•Subject has a history of their stereotypical seizure cluster progressing to status epilepticus (as determined by the investigator) within the 2 years before Visit 1
•Subject has acute narrow-angle glaucoma.
•Subject has had an active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 as defined by a Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation score =3, any suicide attempt in the past 5 years as determined by the C-SSRS or medical history, or other clinically significant suicidality as determined by the investigator
•Subject is currently using a vagal nerve stimulator (VNS) unless the device has been implanted for at least 6 months and the settings have not changed within 4 weeks before Visit 1.

Study & Design

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