RENAISSANCE 2: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of SPN-817 in Adults With Focal Onset Seizures
Supernus Pharmaceuticals, Inc.
Summary
This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 in adults with focal onset seizures.
Description
This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 administered as an adjunctive treatment in adults with focal onset seizures that have previously failed at least 2 anti-seizure medication (ASM) regimens. Participants will be taking 1 to 4 ASMs, with at least 4 seizures during the 6-week Screening Period. Following the Screening Period, eligible participants will be randomized 2:1 to SPN-817 (3.0-4.0 mg BID) or placebo and begin the Titration Period (8-10 weeks). In both treatment grou…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of treatment-resistant focal epilepsy as adjudicated by the Epilepsy Study Consortium, Inc (ESCI); 2. Failed to achieve sustained seizure freedom after ≥2 tolerated, appropriately chosen, and adequately dosed ASM drug schedules; 3. Able to keep accurate Seizure electronic diaries \[eDiaries\] (with the aid of a caregiver as needed); 4. Has a body mass index (BMI) between 18.0 and 40.0 kg/m2; 5. Treatment with a stable dose of 1 to 4 current ASMs for ≥28 days prior to screening. If following a diet plan along with the ASM, the participant should have been on a…
Interventions
- DrugSPN-817
SPN-817 starting at 0.25 mg bid up to 4.00 mg bid
- DrugPlacebo
Placebo, bid
Location
- Medsol Clinical Research CenterPort Charlotte, Florida