Trial record 1 of 1 for:    P261-402
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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 June 2014 by Upsher-Smith Laboratories
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT01529034
First received: February 3, 2012
Last updated: June 9, 2014
Last verified: June 2014
  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
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 [ Designated as safety issue: Yes ]
    Adverse events, clinical laboratory assessments, sedation, vital signs, physical exams, C-SSRS


Secondary Outcome Measures:
  • Treatment Success [ Designated as safety issue: No ]
    Termination of seizure(s) within 10 minutes and no recurrence within 4 hours after study drug administration


Estimated Enrollment: 155
Study Start Date: July 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL261 Drug: USL261

  Eligibility

Ages Eligible for Study:   14 Years to 66 Years
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 Terminated
Scottsdale, Arizona, United States
United States, Arizona Recruiting
Tuscon, Arizona, United States
Contact    866-372-0526      
United States, Arkansas
United States, Arkansas Recruiting
Little Rock, Arkansas, United States
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United States, California
United States, California Recruiting
Loma Linda, California, United States
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United States, California Withdrawn
Sacramento, California, United States
United States, California Recruiting
Ventura, California, United States
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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 Recruiting
Gulf Breeze, Florida, United States
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United States, Florida Withdrawn
Miami, Florida, United States
United States, Florida Terminated
Tampa, Florida, United States
United States, Florida Withdrawn
Tampa, Florida, United States
United States, Florida Recruiting
Wellington, 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
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Chicago, Illinois, United States
United States, Kansas
United States, Kansas Terminated
Manhattan, Kansas, United States
United States, Kentucky
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Louisville, Kentucky, United States
United States, Maryland
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
United States, Michigan
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Detroit, Michigan, United States
United States, Minnesota
United States, Minnesota Recruiting
St. Paul, Minnesota, United States
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St. Paul, Minnesota, United States
United States, Missouri
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Chesterfield, Missouri, United States
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United States, New Jersey
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Gibbsboro, New Jersey, United States
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Hackensack, New Jersey, United States
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New Brunswick, New Jersey, United States
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United States, New York
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Albany, New York, United States
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Bronx, New York, United States
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New York, New York, United States
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United States, North Carolina
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Durham, North Carolina, United States
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United States, Ohio
United States, Ohio Withdrawn
Columbus, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Oregon
United States, Oregon Recruiting
Portland, Oregon, United States
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United States, Pennsylvania
United States, Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States
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United States, Tennessee
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Nashville, Tennessee, United States
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United States, Texas
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Dallas, Texas, United States
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United States, Texas Withdrawn
Fort Worth, Texas, United States
United States, Virginia
United States, Virginia Withdrawn
Norfolk, Virginia, United States
United States, Wisconsin
United States, Wisconsin Recruiting
Madison, Wisconsin, United States
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United States, Wisconsin Withdrawn
Marshfield, Wisconsin, United States
Australia, New South Wales
Australia, New South Wales Recruiting
Chatswood, New South Wales, Australia
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Australia, New South Wales Recruiting
Randwick, New South Wales, Australia
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Australia, New South Wales Recruiting
West Mead, New South Wales, Australia
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Australia, Victoria
Australia, Victoria Recruiting
Fitzroy, Victoria, Australia
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Australia, Victoria Recruiting
Heidelberg west, Victoria, Australia
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Australia, Victoria Recruiting
Parkville, Victoria, Australia
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Canada, Ontario
Canada, Toronto Recruiting
Toronto, Ontario, Canada
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Canada, Quebec
Canada, Quebec Recruiting
Montreal, Quebec, Canada
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Germany
Germany Recruiting
Ulm, Baden-Wurttemberg, Germany
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Germany, Bonn Recruiting
Nordrhein-Westfalen, Bonn, Germany
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Germany, Erlangen Recruiting
Bayern, Erlagen, Germany
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Germany, Frieburg Recruiting
Baden, Frieburg, Germany
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Germany, Marburg Recruiting
Hessen, Marburg, Germany
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Germany, Munchen Withdrawn
Bayern, Munchen, Germany
Germany, Westfalen-Lippe Recruiting
Bielfeld, Westfalen-Lippe, Germany
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Hungary
Hungary Recruiting
Budapest, Hungary
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Hungary Recruiting
Kazincbarcika, Hungary
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Hungary Recruiting
Miskolc, Hungary
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Hungary Recruiting
Nyiregyhaza, Hungary
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Hungary Recruiting
Pecs, Hungary
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Israel
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Haifa, Israel
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Israel Recruiting
Holon, Israel
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Jerusalem, Israel
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Israel Recruiting
Ramat Gan, Israel
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Israel Recruiting
Tel Aviv, Israel
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Italy
Italy, Lombardy Recruiting
Pavia, Lombardy, Italy
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Italy Recruiting
Bari, Italy
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Italy Recruiting
Firenze, Italy
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Italy Recruiting
Genova, Italy
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Italy Recruiting
Milano, Italy
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Italy Recruiting
Napoli, Italy
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Italy Recruiting
San Fermo della Battaglia (CO), Italy
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New Zealand
New Zealand, Auckland Recruiting
Grafton, Auckland, New Zealand
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New Zealand, Canterbury Recruiting
Christchurch, Canterbury, New Zealand
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New Zealand, Waikato Recruiting
Hamilton, Waikato, New Zealand
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Poland
Poland Recruiting
Gdansk, Poland
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Poland Recruiting
Karkow, Poland
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Poland Recruiting
Katowice-Ochojec, Poland
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Spain
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Tarassa, Catalonia, Spain
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Gerona, Cataluyna, Spain
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Spain, Madrid Terminated
Mirasierra, Madrid, Spain
Spain, Madrid Recruiting
Posuelo de Alarcon, Madrid, Spain
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Spain, Madrid Withdrawn
Madrid, Spain
Ukraine
Ukraine, Ivano-Frankivsk Recruiting
Ivano-Frankivsk, Ukraine
Contact    0^00-11      
Ukraine, Kharkiv Withdrawn
Kharkiv, Ukraine
Ukraine, Kharkiv Recruiting
Kharkiv, Ukraine
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Ukraine, Ternopil Recruiting
Ternopil, Ukraine
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Ukraine, Vinnytsa Recruiting
Vinnytsa, Ukraine
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Ukraine Withdrawn
Zaporizhzhya, Ukraine
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

No publications provided

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: June 9, 2014
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 July 29, 2014