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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01529034
First Posted: February 8, 2012
Last Update Posted: September 21, 2017
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.
Information provided by (Responsible Party):
Proximagen, LLC
  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: None (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 Proximagen, LLC:

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


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


Enrollment: 175
Actual Study Start Date: July 2012
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL261
5 mg intranasal midazolam
Drug: USL261

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01529034


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

Responsible Party: Proximagen, LLC
ClinicalTrials.gov Identifier: NCT01529034     History of Changes
Other Study ID Numbers: P261-402
2011-004109-25 ( EudraCT Number )
First Submitted: February 3, 2012
First Posted: February 8, 2012
Last Update Posted: September 21, 2017
Last Verified: May 2017

Keywords provided by Proximagen, LLC:
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