Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT01142193
First received: June 9, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.


Condition Intervention Phase
Epilepsy
Drug: USL255
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures

Resource links provided by NLM:


Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline. [ Time Frame: 3 weeks (weeks 1-3) ] [ Designated as safety issue: No ]
  • Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline. [ Time Frame: 3 weeks (weeks 1-3) ] [ Designated as safety issue: No ]
  • Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase. [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline. [ Time Frame: 3 weeks (weeks 1-3) ] [ Designated as safety issue: No ]
  • Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline. [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. [ Time Frame: 8 weeks (weeks 4-11) ] [ Designated as safety issue: No ]
  • Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. [ Time Frame: 8 weeks (weeks 4-11) ] [ Designated as safety issue: No ]
  • Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline. [ Time Frame: 8 weeks (weeks 4-11) ] [ Designated as safety issue: No ]

Enrollment: 249
Study Start Date: May 2010
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: USL255 Drug: USL255
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1.
  • Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).
  • Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.

Exclusion Criteria:

  • Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1.
  • Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1.
  • Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.
  • Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1.
  • Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.
  • Have taken topiramate within the past 6 months.
  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: NCT01142193

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States
United States, California
Ventura, California, United States
United States, Florida
Gainesville, Florida, United States
Gulf Breeze, Florida, United States
Jacksonville, Florida, United States
Pensacola, Florida, United States
Port Charlotte, Florida, United States
United States, Idaho
Boise, Idaho, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Maryland
Waldorf, Maryland, United States
United States, Missouri
Chesterfield, Missouri, United States
St. Louis, Missouri, United States
United States, New Jersey
New Brunswick, New Jersey, United States
United States, New York
New York, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Ohio
Toledo, Ohio, United States
United States, Texas
Dallas, Texas, United States
Temple, Texas, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Argentina
Buenos Aires, Argentina
Cordoba, Argentina
Guaymallen, Argentina
Salta, Argentina
Australia
Bedford Park, Australia
Clayton, Australia
Fitzory, Australia
Heidelberg West, Australia
Parkville, Australia
Randwick, Australia
Woodville, Australia
Belgium
Brugge, Belgium
Duffel, Belgium
Leuven, Belgium
Canada
Greenfield Park, Canada
Chile
Santiago, Chile
Valdivia, Chile
Germany
Bonn, Germany
Munchen, Germany
Greece
Athens, Greece
Thessaloniki, Greece
Hungary
Budapest, Hungary
India
Bangalore, India
Dehradun, India
Hyderabad, India
Mangalore, India
New Delhi, India
Israel
Ashkelon, Israel
Haifa, Israel
Holon, Israel
Nahariya, Israel
Petach Tikva, Israel
Ramat Gan, Israel
New Zealand
Auckland, New Zealand
Poland
Gdansk, Poland
Krakow, Poland
Lodz, Poland
Lublin, Poland
Warszawa, Poland
Russian Federation
Kazan, Russian Federation
Moscow, Russian Federation
Samara, Russian Federation
St. Petersburg, Russian Federation
Tyumen, Russian Federation
Yaroslavi, Russian Federation
South Africa
Cape Town, South Africa
Spain
Badalona, Spain
Baracaldo, Spain
Granada, Spain
Madrid, Spain
Sponsors and Collaborators
Upsher-Smith Laboratories
  More Information

No publications provided by Upsher-Smith Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT01142193     History of Changes
Other Study ID Numbers: P09-004, 2009-016996-31
Study First Received: June 9, 2010
Results First Received: April 3, 2014
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Upsher-Smith Laboratories:
Epilepsy
partial onset seizure
adjunctive therapy

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

ClinicalTrials.gov processed this record on September 18, 2014