Generalized Epilepsy Study
Are you living with epilepsy?
If you have been diagnosed with generalized epilepsy and are still having tonic-clonic seizures despite taking anti-seizure medication, our clinical trial may be able to help. We are studying an investigational drug to add on to your current epilepsy treatments. There is no cost to you to participate and insurance is not required.
What is Idiopathic Generalized Epilepsy?
Idiopathic generalized epilepsy is a type of epilepsy that affects the entire brain and is usually of unknown causes. People with this condition experience seizures that come on suddenly and affect both sides of the brain at once.
Despite current therapies, a high unmet need exists for further seizure reduction with reduced side effects, for people who are still experiencing seizures while taking currently available anti-seizure medications. About 33% of adults fall into this group.
Biohaven is working with epileptologists and neurologists around the country to research an investigational medication that may be able to help provide better seizure freedom with fewer side effects.
Who is the study for?
If you or a loved one have been diagnosed with idiopathic generalized epilepsy, are between the ages of 18-75 and are still experiencing tonic-clonic seizures while taking one or more anti-seizure medications, you may qualify for the Shine study.
We named this study “Shine” because we believe epilepsy should not stop you from living the bright and shining life of your dreams.
Shine is a study to evaluate the efficacy, safety and tolerability of BHV-7000 in patients with idiopathic generalized epilepsy.
A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Idiopathic Generalized Epilepsy
- Be 18 to 75 years of age.
- Have been unsuccessful with at least 2 anti-seizure medications and currently on a stable dose of at least 1 to 3 anti-seizure medications.
- Have a diagnosis of idiopathic generalized epilepsy (IGE) for at least 6 months, with confirmation of generalized tonic-clonic (GTC) seizures – previously called grand-mal seizures.
- Have experienced at least 3 days with GTC seizures in the 4 months prior to screening.
- The investigational medication or a placebo
- All study-related care, testing and monitoring of your health
- Continuous access to medical professionals who can answer your questions
Frequently Asked Questions
About 250 people will participate in the epilepsy study.
“Double-blind” means that neither you nor the study doctor will know which treatment group you have been assigned to in the study (i.e., if you are receiving BHV-7000 or placebo). A placebo is a “dummy pill” that contains no active ingredients. “Open-label” means that everyone, including you, will know what you are receiving. In the open-label phase of this study, everyone receives BHV-7000; no participants in the open-label phase receive the placebo.
After a Screening period of about 30 days, you will be in the double-blind treatment phase for up to 24 weeks (up to 7 visits). You may be able to stop this phase sooner than 24 weeks, depending on your seizure activity. After the double-blind phase, you may be eligible for the open-label phase of the study to continue to receive the study medication for 48 weeks (8 visits).
To see a full list of participating clinics visit ClinicalTrials.gov.
No. If you qualify and are chosen to participate, you will receive all study-related care, at no cost to you. Insurance is not required, and compensation for participation may be provided.
Like all clinical studies, your participation is fully voluntary. You may leave the study at any time.
Visit the See If You Qualify page to find the nearest clinic.