Sinaloa

Researchers are conducting the X-TOLE3 Phase 3 clinical trial to evaluate the safety, tolerability, and effectiveness of XEN1101 as an additional treatment for adults with focal-onset seizures. The study focuses on measuring changes in seizure frequency when XEN1101 is added to existing antiseizure medications compared to placebo. Participants must have a confirmed diagnosis of focal epilepsy and have tried at least two antiseizure medications without achieving seizure freedom. About 360 participants will be randomly assigned in equal groups to receive either XEN1101 at 25 mg, 15 mg, or a placebo. The study includes up to 9.5 weeks of baseline observation to record seizure frequency, followed by 12 weeks of double-blind treatment where participants take the assigned capsules once daily with an evening meal. Those who complete this period may join a separate open-label extension to continue XEN1101 treatment, while others will enter an 8-week follow-up after treatment ends. During the study, participants will maintain accurate seizure diaries and continue stable doses of 1 to 3 antiseizure medications. Researchers will monitor seizure frequency changes from baseline through the 12-week treatment. Safety and tolerability will also be assessed throughout the trial. The total participation includes baseline, treatment, and follow-up periods to ensure thorough evaluation of the treatment's impact.

Researchers are investigating the safety, tolerability, and effectiveness of XEN1101 as an additional treatment for people with primary generalized tonic-clonic seizures (PGTCS) who have generalized epilepsy and are already taking 1 to 3 anti-seizure medications. This phase 3, multicenter, randomized, double-blind, placebo-controlled study includes participants aged 12 years and older and aims to better understand how XEN1101 affects seizure frequency compared to placebo. Participants will be randomly assigned to receive either XEN1101 or a placebo capsule once daily with their evening meal during a 12-week double-blind treatment period. Those aged 18 and older will take a 25 mg dose of XEN1101 or placebo, while those aged 12 to under 18 may receive 15 mg, 25 mg, or placebo. Before this period, participants will have up to 9.5 weeks to record their baseline seizure frequency. After completing the double-blind period, participants can join an open-label extension study for continued XEN1101 treatment or enter an 8-week follow-up phase if they do not enroll in the extension. During the study, participants will keep detailed seizure diaries and maintain stable doses of their anti-seizure medications. Researchers will monitor seizure frequency changes, safety, and tolerability throughout the treatment. The main measurement is the median percent change in monthly primary generalized tonic-clonic seizure frequency from baseline through the 12-week treatment. Safety follow-up and monitoring will continue during the post-treatment follow-up or open-label extension periods, with total participation lasting several months depending on extension enrollment.

Researchers are evaluating ACP-204, a drug that blocks a specific serotonin receptor, in adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP). The study is designed as a master protocol with three independent, multicenter, randomized, double-blind, placebo-controlled trials. The trials include Phase 2 and Phase 3 studies to assess the drug's effectiveness and safety in treating psychotic symptoms associated with ADP. The research involves three substudies. Substudy 1 (Phase 2) tests two doses of ACP-204, 30 mg and 60 mg, against a placebo to evaluate dose response. Substudies 2A and 2B (both Phase 3) will independently confirm the effects of either both doses or a single dose from Part 1 compared to placebo. Each substudy includes a screening period of up to 49 days, a six-week double-blind treatment phase, and a 30-day safety follow-up for those not continuing into an open-label extension. Vital status follow-up is conducted for participants who end the study early. Participants will receive regular assessments, including evaluations of psychotic symptoms using the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales from baseline to Week 6. Other study involvement includes brain imaging scans and biomarker tests to confirm Alzheimer's disease diagnosis, cognitive testing, and monitoring of safety and vital status throughout the study periods. Stable living arrangements and support from a caregiver are required to complete all study visits.

Researchers are evaluating the safety and effectiveness of palazestrant (OP-1250) compared to standard treatments fulvestrant or an aromatase inhibitor in adults with ER-positive, HER2-negative advanced or metastatic breast cancer. Participants have previously received endocrine therapy combined with a CDK4/6 inhibitor, and their cancer has progressed despite this treatment. This phase 3, international, randomized, open-label trial aims to provide new information on treatment options for this population. Participants will be assigned to receive either palazestrant daily in a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or standard endocrine therapy with fulvestrant or one of three aromatase inhibitors (anastrozole, letrozole, or exemestane), given according to their approved schedules. After selecting the optimal palazestrant dose, more participants will be randomized to receive either that dose or standard care. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will be monitored for adverse events, dose reductions, or treatment discontinuation for up to 16 weeks after randomization. The main outcome is progression-free survival, measured until disease progression or death, with an estimated follow-up of up to 2 years. Assessments will include physical exams, lab tests, and regular evaluations of cancer status and side effects to ensure safety and track the effectiveness of the treatments.

Researchers are evaluating the effectiveness of BHV-7000 in treating adults with refractory focal onset epilepsy, a condition where seizures originate in specific areas of the brain and have not responded to previous treatments. This Phase 2/3 trial aims to assess the safety, tolerability, and ability of BHV-7000 to reduce seizure frequency in participants who continue to have seizures despite using anti-seizure medications. The study follows classification criteria set by the International League Against Epilepsy and includes participants aged 18 to 75 years. Participants will be randomly assigned to receive either BHV-7000 at doses of 50 mg or 75 mg once daily, or a matching placebo, in a double-blind setup where neither participants nor researchers know which treatment is given. The treatment period focuses on monitoring changes in seizure frequency over 28-day averages from baseline through weeks 8 to 16. The study design includes careful control and comparison to evaluate the investigational drug's impact. During the study, participants will keep accurate seizure diaries to track their seizures. Researchers will measure changes in the average number of seizures over 28-day periods as the primary outcome. Safety and tolerability will also be monitored closely. The study requires participants to be currently treated with one to three anti-seizure medications and to meet specific epilepsy criteria. Overall participation includes screening, treatment, and follow-up to assess the drug's effects and participant safety.