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Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures (PROSPER1)

Primary Purpose

Epilepsies, Partial

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
2400mg SPN-804
1200mg SPN-804
Sponsored by
Supernus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsies, Partial focused on measuring Partial onset epilepsy, Partial onset seizures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Capable of complying with the study procedures.
  • Able to provide written informed consent
  • Male or female aged 18 to 65 years, inclusive.
  • Diagnosis of partial onset seizures
  • Minimum of three seizures per 28 days
  • Receiving treatment with 1-3 AEDs
  • Refractory to at least one AED
  • No progressive neurological conditions by recent MRI/CT
  • Adequate birth control in women of child-bearing potential

Exclusion Criteria:

  • Refractory to OXC for reasons of efficacy
  • Recent status epilepticus
  • Recent non-epileptic seizures
  • Current diagnosis of major depression
  • Recent suicidal plan or intent or more than one attempt
  • Current use of oxcarbazepine, felbamate for < 18 months, phenytoin with levels >15mcg/mL or frequent need for rescue benzodiazepines
  • Current use of sodium-lowering non-seizure medications.
  • Clinically significant hepatic, renal, or cardiovascular function
  • History of recent substance abuse
  • Females who are pregnant or lactating.
  • Hypersensitivity to OXC or related drugs
  • Difficulty swallowing study medication

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

2400 mg SPN-804

1200mg SPN-804

Arm Description

Placebo - four identical tablets taken orally once daily

2400mg OXC XR taken orally once daily as four identical tablets

1200mg OXC XR taken orally once daily as four identical tablets

Outcomes

Primary Outcome Measures

PCH(T), ITT
Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population.

Secondary Outcome Measures

PCH(M)- ITT
Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population
Responder Rate, ITT
Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population
Seizure-Free Rates, ITT
Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population
Seizure Free Rate, ITT, (M)
Percent of patients seizure-free during Maintenance, Intent-to-Treat population

Full Information

First Posted
October 10, 2008
Last Updated
December 23, 2013
Sponsor
Supernus Pharmaceuticals, Inc.
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT00772603
Brief Title
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
Acronym
PROSPER1
Official Title
Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Supernus Pharmaceuticals, Inc.
Collaborators
Parexel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures
Detailed Description
Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Partial
Keywords
Partial onset epilepsy, Partial onset seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo - four identical tablets taken orally once daily
Arm Title
2400 mg SPN-804
Arm Type
Active Comparator
Arm Description
2400mg OXC XR taken orally once daily as four identical tablets
Arm Title
1200mg SPN-804
Arm Type
Active Comparator
Arm Description
1200mg OXC XR taken orally once daily as four identical tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sham treatment
Intervention Description
Non-active tablet identical to study drug tablets
Intervention Type
Drug
Intervention Name(s)
2400mg SPN-804
Other Intervention Name(s)
Oxcarbazepine extended-release, Oxtellar XR, Oxtellar
Intervention Description
tablets containing 600mg OXC XR, identical to non-active tablets
Intervention Type
Drug
Intervention Name(s)
1200mg SPN-804
Other Intervention Name(s)
Oxcarbazepine extended-release, Oxtellar XR, Oxtellar
Intervention Description
two active tablets and two non-active tablets, all identical
Primary Outcome Measure Information:
Title
PCH(T), ITT
Description
Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population.
Time Frame
Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline
Secondary Outcome Measure Information:
Title
PCH(M)- ITT
Description
Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population
Time Frame
Change at 12 weeks (Maintenance Period) compared to Baseline
Title
Responder Rate, ITT
Description
Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population
Time Frame
At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
Title
Seizure-Free Rates, ITT
Description
Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population
Time Frame
At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
Title
Seizure Free Rate, ITT, (M)
Description
Percent of patients seizure-free during Maintenance, Intent-to-Treat population
Time Frame
At the end of 12 weeks (Maintenance Period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Capable of complying with the study procedures. Able to provide written informed consent Male or female aged 18 to 65 years, inclusive. Diagnosis of partial onset seizures Minimum of three seizures per 28 days Receiving treatment with 1-3 AEDs Refractory to at least one AED No progressive neurological conditions by recent MRI/CT Adequate birth control in women of child-bearing potential Exclusion Criteria: Refractory to OXC for reasons of efficacy Recent status epilepticus Recent non-epileptic seizures Current diagnosis of major depression Recent suicidal plan or intent or more than one attempt Current use of oxcarbazepine, felbamate for < 18 months, phenytoin with levels >15mcg/mL or frequent need for rescue benzodiazepines Current use of sodium-lowering non-seizure medications. Clinically significant hepatic, renal, or cardiovascular function History of recent substance abuse Females who are pregnant or lactating. Hypersensitivity to OXC or related drugs Difficulty swallowing study medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet K Johnson, PhD
Organizational Affiliation
Supernus Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
Country
United States
City
Northport
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Riverside
State/Province
California
Country
United States
City
West Los Angeles
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Missoula
State/Province
Montana
Country
United States
City
Camden
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Baytown
State/Province
Texas
Country
United States
City
Temple
State/Province
Texas
Country
United States
City
Blagoevgrad
Country
Bulgaria
City
Pleven
Country
Bulgaria
City
Plovdiv
Country
Bulgaria
City
Ruse
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Varna
Country
Bulgaria
City
Edmonton
State/Province
Alberta
Country
Canada
City
Greenfield Park
State/Province
Quebec
Country
Canada
City
Dubrovnik
Country
Croatia
City
Rijeka
Country
Croatia
City
Zadar
Country
Croatia
City
Zagreb
Country
Croatia
City
Ciudad Juárez
State/Province
Chihuahua
Country
Mexico
City
Mexico City
State/Province
DF
Country
Mexico
City
Toluca
State/Province
Estado de Mexico
Country
Mexico
City
Guadalajara
State/Province
Jalisco
Country
Mexico
City
Zapopan
State/Province
Jalisco
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
City
San Luis Potosi
State/Province
San Luis Potosí
Country
Mexico
City
Aguascalientes
Country
Mexico
City
Chihuahua
Country
Mexico
City
Durango
Country
Mexico
City
Puebla
Country
Mexico
City
Gizycko
Country
Poland
City
Katowice
Country
Poland
City
Konskie
Country
Poland
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Warszawa
Country
Poland
City
Wilkowice
Country
Poland
City
Zabrze
Country
Poland
City
Bucharest
Country
Romania
City
Campulung Muscel
Country
Romania
City
Cluj-Napoca
Country
Romania
City
Craiova
Country
Romania
City
St Petersburg
State/Province
Sestroretsk
Country
Russian Federation
City
Kazan
Country
Russian Federation
City
Kirov
Country
Russian Federation
City
Kursk
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizhniy Novgorod
Country
Russian Federation
City
Nizhny Novgorod
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Pyatigorsk
Country
Russian Federation
City
Samara
Country
Russian Federation
City
Smolensk
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures

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