SHINE
Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects with Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures
Purpose
Despite availability of new treatments for epilepsy, there is an unmet need for treatments with greater efficacy and improved tolerability. BHV-7000 does not exhibit the GABAA receptor PAM activity seen with ezogabine and some other ASMs, which may contribute to their poor tolerability observed both non-clinically and clinically. This study is to evaluate BHV-7000 as adjunctive therapy for idiopathic generalized epilepsy with generalized tonic-clonic seizures.
Who can participate
Patients who satisfy the requirements listed below are eligible to participate:
- Male and Female, 18 to 75 years of age
- Diagnosis of Idiopathic Generalized Epilepsy (IGE) at least 6 months at least 3 days evenly spread throughout 16 weeks
- Drug resistant epilepsy
- Current treatment 1 to 3 ASMs as part of no more than 4 stable epilepsy treatments. ASMs must have a stable dose(s) for at least 1 month
- If use felbamate, must be taking it for at least 1 year, with a stable dose for 2 months
- If use vigabatrin, must be taking it for at least 2 years and have appropriate documentation of normal visual fields
- Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulation (RNS): (1) That was implanted or activated > 1 year prior to the screening visit, and (2) stable for > 3 months, and (3) Battery life of unit anticipated to extend for duration of trial
- Epilepsy dietary therapy initiated > 3 months prior
- Body mass index (BMI) < 35 kg/m2
Visits
Patients can expect a 6 week screening period and then 24 weeks of visits (day 1, and weeks 2, 4, 8, 12, 18 and 24). There is optional open label extension with an additional 48 weeks (2, 4, 8, 12, 18, 24, 36 and 48), should a patient choose to continue.
