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

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00772603
First received: October 10, 2008
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures


Condition Intervention Phase
Epilepsies, Partial
Drug: Placebo
Drug: 2400mg SPN-804
Drug: 1200mg SPN-804
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Resource links provided by NLM:


Further study details as provided by Supernus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • PCH(T), ITT [ Time Frame: Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change at 12 weeks (Maintenance Period) compared to Baseline ] [ Designated as safety issue: No ]
    Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population

  • Responder Rate, ITT [ Time Frame: At the end of 16 weeks (4 wks Titration + 12 wks Maintenance) ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the end of 16 weeks (4 wks Titration + 12 wks Maintenance) ] [ Designated as safety issue: No ]
    Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population

  • Seizure Free Rate, ITT, (M) [ Time Frame: At the end of 12 weeks (Maintenance Period) ] [ Designated as safety issue: No ]
    Percent of patients seizure-free during Maintenance, Intent-to-Treat population


Enrollment: 366
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo - four identical tablets taken orally once daily
Drug: Placebo
Non-active tablet identical to study drug tablets
Other Name: sham treatment
Active Comparator: 2400 mg SPN-804
2400mg OXC XR taken orally once daily as four identical tablets
Drug: 2400mg SPN-804
tablets containing 600mg OXC XR, identical to non-active tablets
Other Names:
  • Oxcarbazepine extended-release
  • Oxtellar XR
  • Oxtellar
Active Comparator: 1200mg SPN-804
1200mg OXC XR taken orally once daily as four identical tablets
Drug: 1200mg SPN-804
two active tablets and two non-active tablets, all identical
Other Names:
  • Oxcarbazepine extended-release
  • Oxtellar XR
  • Oxtellar

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00772603

  Show 73 Study Locations
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
Parexel
Investigators
Study Director: Janet K Johnson, PhD Supernus Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00772603     History of Changes
Other Study ID Numbers: 804P301
Study First Received: October 10, 2008
Results First Received: April 9, 2013
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Supernus Pharmaceuticals, Inc.:
Partial onset epilepsy
Partial onset seizures

Additional relevant MeSH terms:
Oxcarbazepine
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014