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Trial record 1 of 4 for:    USL261
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A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02161185
Recruitment Status : Terminated (Study terminated due to slow enrollment. There were no safety concerns.)
First Posted : June 11, 2014
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Proximagen, LLC

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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: USL261 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Safety Study of USL261 in the Outpatient Treatment of Adolescent and Adult Subjects With Seizure Clusters
Study Start Date : May 2014
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
U.S. FDA Resources

Arm Intervention/treatment
USL261 Drug: USL261
5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Other Name: Intranasal Midazolam



Primary Outcome Measures :
  1. Long-term safety and tolerability [ Time Frame: approximately 2 years ]
    Adverse Events, clinical laboratory results, vital signs, respiration rate, the number of subjects requiring emergency rescue treatment, C-SSRS, physical, nasal, olfactory and neurological examination results


Secondary Outcome Measures :
  1. Treatment success [ Time Frame: Approximately 2 years ]
    Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 minumum 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 40kg 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 sucidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161185


Locations
United States, Arizona
Tucson, Arizona, United States
United States, California
Fresno, California, United States
Ventura, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Florida
Port Charlotte, Florida, United States
Tampa, Florida, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Minnesota
Saint Paul, Minnesota, United States
United States, Nevada
Reno, Nevada, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Sponsors and Collaborators
Proximagen, LLC
Investigators
Study Director: TzeChiang Meng, MD Proximagen, LLC

Responsible Party: Proximagen, LLC
ClinicalTrials.gov Identifier: NCT02161185     History of Changes
Other Study ID Numbers: P261-408
2014-001604-22 ( EudraCT Number )
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: June 2016

Keywords provided by Proximagen, LLC:
Epilepsy
seizure cluster
acute repetitive seizures
open-label
intranasal Midazolam
USL261
Upsher-Smith

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action