RISE 2

Summary

Also known as partial epilepsy, focal onset epilepsy is the most common form of epilepsy. This common neurologic disorder is characterized by abnormal electrical activity in a specific area of the brain. The resulting symptoms can range from subtle sensory disturbances to more pronounced motor movements and altered consciousness. Current therapeutic options for focal onset epilepsy include anti-epileptic medications, lifestyle modifications, and potentially even surgical interventions.

However, interventions that offer further seizure reduction and reduced side effects are urgently needed. In particular, about 33% of adults with focal onset epilepsy still experience seizures despite treatment with current anti-seizure medications. The RISE 2 study investigates whether a new compound, BHV-7000, is safe and effective in men and women with focal onset epilepsy that does not respond well to current treatments. Researchers hope that BHV-7000 will reduce seizure intensity and frequency, decrease side effects, and improve quality of life.

Participants approved to join the RISE 2 study are randomly assigned (50:50, like a coin toss) either BHV-7000 or a pill that looks the same but does not contain any medication. Neither the lead scientist nor participants will know or can choose which study treatment they receive. Throughout the study, participants will have regular health assessments and check-ins with their research teams.

To be included in RISE 2, participants must be / have

• Adults (18 – 75 years of age)
• Diagnosis of focal onset epilepsy at least 1 year prior to screening
• Focal aware seizures with clinically observable signs and/or symptoms OR focal impaired awareness seizures OR focal to bilateral tonic–clonic seizures
• Drug-resistant epilepsy
• Current treatment with 1 – 3 anti-seizure medications and up to 4 epilepsy treatments in total

To be included in RISE 2, participants must not be / have

• History of status epilepticus within the last 6 months prior to screening that's inconsistent with habitual seizures
• History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase
• Resection neurosurgery for seizures less than 4 months prior to screening
• Radiosurgery performed less than 2 years prior to screening

Keywords
Epilepsy; Focal onset epilepsy; Partial epilepsy; Refractory focal onset epilepsy; Seizures