Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Upsher-Smith Laboratories
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT01529034
First received: February 3, 2012
Last updated: November 21, 2016
Last verified: November 2016
  Purpose
The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

Condition Intervention Phase
Epilepsy
Drug: USL261
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects With Seizure Clusters

Resource links provided by NLM:


Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • Long-term safety and tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Adverse events, clinical laboratory assessments, sedation, vital signs, physical exams, C-SSRS


Secondary Outcome Measures:
  • Treatment Success [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration


Estimated Enrollment: 204
Study Start Date: July 2012
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL261
5 mg intranasal midazolam
Drug: USL261

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
  • Has successfully completed study P261-401, and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator

Exclusion Criteria:

  • Has experienced status epilepticus during or since the P261-401 study
  • In the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study
  • Has a neurological disorder that is likely to progress in the next year
  • Has a history of acute narrow-angle glaucoma
  • Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy
  • Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen
  • Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study
  • Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical history
  • Subject has had vagus nerve stimulator (VNS) implanted since the completion of study P261-401
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529034

Contacts
Contact: Gerrit Ross 1-866-372-0526

  Hide Study Locations
Locations
United States, Arizona
United States, Arizona Recruiting
Phoenix, Arizona, United States
Contact    866-372-0526      
United States, Arizona Terminated
Scottsdale, Arizona, United States
United States, Arizona Terminated
Tuscon, Arizona, United States
United States, Arkansas
United States, Arkansas Terminated
Little Rock, Arkansas, United States
United States, California
United States, California Recruiting
Orange, California, United States
Contact    866-372-0526      
United States, California Recruiting
Sacramento, California, United States
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United States, California Terminated
Ventura, California, United States
United States, Colorado
United States, Colorado Recruiting
Aurora, Colorado, United States
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United States, Connecticut
United States, Connecticut Recruiting
New Haven, Connecticut, United States
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United States, Florida
United States, Florida Terminated
Gulf Breeze, Florida, United States
United States, Florida Recruiting
Loxahatchee, Florida, United States
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United States, Florida Recruiting
Port Charlotte, Florida, United States
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United States, Idaho
United States, Idaho Recruiting
Boise, Idaho, United States
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United States, Illinois
United States, Illinois Recruiting
Chicago, Illinois, United States
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United States, Kansas
United States, Kansas Terminated
Manhattan, Kansas, United States
United States, Kentucky
United States, Kentucky Recruiting
Lexington, Kentucky, United States
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United States, Maryland
United States, Maryland Recruiting
Baltimore, Maryland, United States
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United States, Michigan
United States, Michigan Terminated
Detroit, Michigan, United States
United States, Minnesota
United States, Minnesota Recruiting
St. Paul, Minnesota, United States
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United States, Missouri
United States, Missouri Recruiting
St. Louis, Missouri, United States
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United States, Nevada
United States, Nevada Recruiting
Reno, Nevada, United States
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United States, New Hampshire
United States, New Hampshire Terminated
Lebanon, New Hampshire, United States
United States, New Jersey
United States, New Jersey Terminated
Hackensack, New Jersey, United States
United States, New York
United States, New York Recruiting
Bronx, New York, United States
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United States, New York Terminated
New York, New York, United States
United States, New York Recruiting
New York, New York, United States
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United States, New York Recruiting
Stony Brook, New York, United States
United States, North Carolina
United States, North Carolina Terminated
Durham, North Carolina, United States
United States, North Carolina Recruiting
Winston-Salem, North Carolina, United States
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United States, Ohio
United States, Ohio Terminated
Columbus, Ohio, United States
United States, Oklahoma
United States, Oklahoma Terminated
Oklahoma City, Oklahoma, United States
United States, Oregon
United States, Oregon Terminated
Portland, Oregon, United States
United States, Pennsylvania
United States, Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States
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United States, Tennessee
United States, Tennessee Recruiting
Memphis, Tennessee, United States
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United States, Tennessee Recruiting
Nashville, Tennessee, United States
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United States, Texas
United States, Texas Terminated
Dallas, Texas, United States
United States, Texas Terminated
Fort Worth, Texas, United States
United States, Texas Recruiting
Greenville, Texas, United States
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United States,Texas Recruiting
San Antonio, Texas, United States
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United States, Virginia
United States, Virginia Terminated
Norfolk, Virginia, United States
United States, Wisconsin
United States, Wisconsin Terminated
Madison, Wisconsin, United States
Australia, New South Wales
Australia, New South Wales Terminated
Randwick, New South Wales, Australia
Australia, Queensland
Australia Recruiting
Herston, Queensland, Australia
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Australia, Victoria
Australia, Victoria Recruiting
Heidelberg west, Victoria, Australia
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Australia, Victoria Recruiting
Parkville, Victoria, Australia
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Canada, Ontario
Canada Recruiting
Montreal, Ontario, Canada
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Canada, Toronto Recruiting
Toronto, Ontario, Canada
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Canada, Quebec
Canada, Quebec Recruiting
Montreal, Quebec, Canada
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Canada Recruiting
Toronto, Quebec, Canada
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Germany
Germany Recruiting
Ulm, Baden-Wurttemberg, Germany
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Germany Terminated
Munchen, Bayern, Germany
Germany Terminated
Marberg, Hessen, Germany
Germany Recruiting
Bonn, Nordrhein-Westfalen, Germany
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Germany Terminated
Bielfeld, Westfalen-Lippe, Germany
Hungary
Hungary Recruiting
Budapest, Hungary
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Hungary Terminated
Kazincbarcika, Hungary
Israel
Israel Recruiting
Haifa, Israel
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Israel Recruiting
Petah Tikvah, Israel
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Israel Recruiting
Ramat Gan, Israel
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Italy
Italy Recruiting
Firenze, Italy
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Italy Recruiting
Milano, Italy
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Italy Recruiting
Pavia, Italy
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New Zealand
New Zealand Terminated
Christchurch, Canterbury, New Zealand
Poland
Poland Terminated
Gdansk, Poland
Poland Recruiting
Katowice-Ochojec, Poland
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Poland Recruiting
Lublin, Poland
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Spain
Spain Terminated
Sevilla, Andalucia, Spain
Spain Terminated
Tarrassa, Barcelona, Spain
Spain Recruiting
Gerona, Cataluyna, Spain
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Spain Terminated
Mirasierra, Madrid, Spain
Spain Terminated
Posuelo de Alarcon, Madrid, Spain
Spain Terminated
Madrid, Spain
Ukraine
Ukraine Recruiting
Ivano-Frankivsk, Ukraine
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Ukraine Recruiting
Kharkiv, Ukraine
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Ukraine Terminated
Odessa, Ukraine
Ukraine Recruiting
Odessa, Ukraine
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Ukraine Recruiting
Poltava, Ukraine
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Ukraine Recruiting
Ternopil, Ukraine
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Ukraine Recruiting
Vinnytsa, Ukraine
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Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT01529034     History of Changes
Other Study ID Numbers: P261-402  2011-004109-25 
Study First Received: February 3, 2012
Last Updated: November 21, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Upsher-Smith Laboratories:
Epilepsy
seizure clusters
acute repetitive seizures
rescue treatment

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on December 02, 2016