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

Supernus Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Epilepsies, Partial

Treatments: Drug: Placebo; Drug: 2400mg SPN-804; Drug: 1200mg SPN-804

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772603

804P301

Details and patient eligibility

About

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

Full 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.

Enrollment: 366 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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366 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo - four identical tablets taken orally once daily

Treatment:

Drug: Placebo

2400 mg SPN-804

Active Comparator group

Description:

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

Treatment:

Drug: 2400mg SPN-804

1200mg SPN-804

Active Comparator group

Description:

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

Treatment:

Drug: 1200mg SPN-804