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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772603
First Posted: October 15, 2008
Last Update Posted: February 11, 2014
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.
Collaborator:
Parexel
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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) ]
    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) ]
    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) ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT00772603


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

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00772603     History of Changes
Other Study ID Numbers: 804P301
First Submitted: October 10, 2008
First Posted: October 15, 2008
Results First Submitted: April 9, 2013
Results First Posted: February 11, 2014
Last Update Posted: February 11, 2014
Last Verified: December 2013

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

Additional relevant MeSH terms:
Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Oxcarbazepine
Carbamazepine
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents