Roseville

Researchers are evaluating BHV-7000 as a treatment for adults with refractory focal onset epilepsy, a form of epilepsy that does not respond to standard anti-seizure medications. The study aims to determine if BHV-7000 can reduce seizure frequency and assess its safety and tolerability. This Phase 23 clinical trial is sponsored by Biohaven Therapeutics Ltd. and involves participants aged 18 to 75 years with a diagnosis of focal epilepsy lasting at least one year and resistant to previous treatments. The trial consists of two parts. In Part A, participants are randomly assigned to receive either 25 mg or 50 mg of BHV-7000 once daily or a matching placebo. After completing Part A, participants may enter Part B, which involves randomization to either 75 mg of BHV-7000 once daily or placebo. Both parts are blinded, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment periods. Participants will keep accurate seizure diaries throughout the study to track seizure frequency. Researchers will monitor safety by recording adverse events and laboratory abnormalities from Week 8 to Week 20 in both parts. The main outcome measured in Part B is the change in average seizure frequency over 28 days compared to baseline. Secondary outcomes include the percentage of participants with significant seizure reduction and seizure freedom during the study. The total participation duration includes treatment and follow-up assessments over several weeks.

Researchers are evaluating clemizole HCl as an additional treatment for children and adults aged 2 to 55 years who have Lennox-Gastaut syndrome LGS, a condition characterized by seizures and abnormal brain activity. This Phase 3 trial aims to assess how well clemizole HCl works and how safe it is when added to existing treatments. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will go through three main phases an Observational Period, a Double-Blind Period, and an optional Open-Label Extension. During the Double-Blind Period, participants receive either clemizole HCl or a placebo as an oral solution. Those who complete this phase may continue to receive clemizole HCl for up to three years in the Open-Label Extension Phase. Throughout the study, participants will be monitored closely with various assessments, including measuring seizure frequency using the CMMS-28 scale over up to 16 weeks. Researchers will also check global impressions of change, quality of life scores, and record any treatment-emergent side effects. The studys overall duration may last up to several years, allowing for long-term safety and effectiveness monitoring.

Researchers are collecting and storing blood, DNA, and tissue samples from individuals diagnosed with tuberous sclerosis complex TSC or lymphangioleiomyomatosis LAM to support scientific research. These samples are linked to detailed clinical data that tracks the health impact of TSC over a persons lifetime, gathered both retrospectively and prospectively. This project aims to improve understanding of TSC and related conditions affecting various organs such as the brain, kidney, heart, lungs, and skin. Participants may provide biosamples through various methods, including blood draws, cheek swabs, genetic testing, or tissue donations following routine medical procedures. Samples can be collected at clinical study sites, participants homes, educational meetings, or through approved clinical partners using supplied kits and instructions. All collected samples are sent to a central biobank for processing, storage, and distribution to researchers after appropriate approvals. During participation, individuals contribute their samples and clinical information, which is stored in the TSC Natural History Database. Researchers monitor genetic variants through sequencing and may offer participants genetic counseling if they opt to receive their results. The project involves ongoing collection and sharing of biosamples and data, with an average follow-up of 15 years to study the natural history of TSC and LAM.