A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters
NCT ID: NCT02161185
Last Updated: 2019-10-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
7 participants
INTERVENTIONAL
2014-05-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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USL261
USL261
5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Interventions
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USL261
5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
65 Years
ALL
No
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Principal Investigators
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TzeChiang Meng, MD
Role: STUDY_DIRECTOR
Proximagen, LLC
Locations
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Tucson, Arizona, United States
Fresno, California, United States
Ventura, California, United States
Aurora, Colorado, United States
Port Charlotte, Florida, United States
Tampa, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Saint Paul, Minnesota, United States
Reno, Nevada, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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2014-001604-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P261-408
Identifier Type: -
Identifier Source: org_study_id
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