A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters

Epilepsy Clinical Trial

Official title:

An Open-Label Safety Study of USL261 in the Outpatient Treatment of Adolescent and Adult Subjects With Seizure Clusters

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02161185
• Other study ID #: P261-408
• Secondary ID: 2014-001604-22
• Status: Terminated
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2019
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes

2. Has an established diagnosis of partial or generalized epilepsy that includes all the following:

• A documented history of seizure clusters lasting a minimum of 10 minutes, seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)

• A second seizure in the seizure cluster typically occurs within 6 hours from the time of recognition

• A seizure cluster pattern composed of multiple (= 2) partial or generalized seizures

• A seizure cluster pattern 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 occuring = 4 months before Visit 1

3. Currently on a stable regimen of AED(s) that includes a benzodiazepine

4. Weight is 40 kg to 125 kg, inclusive

Exclusion Criteria:

1. Has a neurological disorder that is likely to progress in the next year

2. Has a severe chronic cardio-respiratory disease

3. Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1

4. Has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before Visit 1

5. Has a history of acute narrow-angle glaucoma

6. Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• USL261
5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation	Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study	Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Secondary	Treatment Success	Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration. Due to early termination of the study, this data was not analyzed.	Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.