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

Epilepsies, Partial Clinical Trial

— PROSPER1  

Official title:

Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772603
• Other study ID #: 804P301
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2008
• Last updated: December 23, 2013
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: December 2013
• Source: Supernus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: November 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial

Intervention

Drug:
• Placebo
Non-active tablet identical to study drug tablets
• 2400mg SPN-804
tablets containing 600mg OXC XR, identical to non-active tablets
• 1200mg SPN-804
two active tablets and two non-active tablets, all identical

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Supernus Pharmaceuticals, Inc.	Parexel

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Croatia,  Mexico,  Poland,  Romania,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCH(T), ITT	Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population.	Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline	No
Secondary	PCH(M)- ITT	Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population	Change at 12 weeks (Maintenance Period) compared to Baseline	No
Secondary	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	At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)	No
Secondary	Seizure-Free Rates, ITT	Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population	At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)	No
Secondary	Seizure Free Rate, ITT, (M)	Percent of patients seizure-free during Maintenance, Intent-to-Treat population	At the end of 12 weeks (Maintenance Period)	No