Study to Evaluate the Safety and Effectiveness of USL261 in Patients With Seizure Clusters

This study is currently recruiting participants.

Verified April 2013 by Upsher-Smith Laboratories

Sponsor:

Information provided by (Responsible Party):

Upsher-Smith Laboratories

ClinicalTrials.gov Identifier:

NCT01390220

First received: July 6, 2011

Last updated: April 16, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 6, 2011

Last Updated Date

April 16, 2013

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects who meet the criteria for Treatment Success. [ Designated as safety issue: No ]

Treatment Success is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after study drug administration, and 2) no recurrence of seizure(s) within 4 hours after study drug administration.

Original Primary Outcome Measures ^ICMJE

Proportion of subjects who meet the criteria for Treatment Success.

Change History

Complete list of historical versions of study NCT01390220 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Occurrence of seizure(s) within 6 hours after study drug administration.
Time to next seizure after study drug administration.
Frequency of seizure(s) within 6 hours after administration of study drug.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Evaluate the Safety and Effectiveness of USL261 in Patients With Seizure Clusters

Official Title ^ICMJE

A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Intranasal Midazolam (USL261) in the Outpatient Treatment of Subjects With Seizure Clusters

Brief Summary

The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: USL261
Drug: Placebo

Study Arm (s)

Experimental: USL261
Intervention: Drug: USL261
Experimental: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

155

Completion Date

Not Provided

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
Has an established diagnosis of partial or generalized epilepsy that includes the following:
- A documented history of seizure clusters lasting > 10 minutes and < 6 hours, with a pattern that is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity, if any;
- 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 ≥ 4 seizure clusters during the year before Visit 1;
- At least 1 seizure cluster occurring ≤ 3 months before Visit 1;
- Seizure cluster pattern is confirmed by a central reviewer
Currently on a stable dosing regimen of AEDs since Visit 1 and for ≥ 7 days before Visit 2, with or without intermittent use of benzodiazepines at a constant dose

Exclusion Criteria:

Has a neurological disorder that is likely to progress in the next year
Has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
Has a history of their stereotypical seizure cluster progressing to status epilepticus within the 2 years before Visit 1 or has a history of seizure clusters progressing to status epilepticus despite therapeutic intervention
Have a history of acute narrow-angle glaucoma.
Has had an active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or any lifetime suicide attempt
Taking felbamate for less than 18 consecutive months before Visit 1 or has discontinued felbamate within 30 days before Visit 1
Currently taking or has taken vigabatrin within 1 year before Visit 1
Taken vigabatrin in the past and has either no documentation of visual field exam or documentation on an abnormal visual field exam
Currently using a VNS unless the device has been implanted for at least 6 months and the setting stable for 4 weeks before Visit 1

Gender

Both

Ages

14 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Gerrit Ross

1-866-372-0526

Location Countries ^ICMJE

United States, Australia, Canada, Germany, Hungary, Israel, Italy, New Zealand, Poland, Spain, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT01390220

Other Study ID Numbers ^ICMJE

P261-401, 2011-001318-32

Has Data Monitoring Committee

Not Provided

Responsible Party

Upsher-Smith Laboratories

Study Sponsor ^ICMJE

Upsher-Smith Laboratories

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Upsher-Smith Laboratories

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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