West Covina

This research investigates how using cannabis (also known as marijuana, weed, or THC) affects the quality of life for patients with multiple myeloma who are undergoing chemotherapy. It aims to compare the experiences of cannabis users and non-users, focusing on potential benefits and harms related to cannabis use. The study uses specific tools like the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) and symptom assessments to better understand these effects over time. Participants are divided into two groups. One group completes surveys and provides blood samples regularly throughout the study, while healthcare providers complete separate surveys about their care practices. This observational study does not involve giving any new treatments but monitors patients receiving their usual cancer-directed therapies, including any cannabis use. During the study, patients complete questionnaires about their quality of life and symptoms, and medical professionals assess any side effects. The study measures outcomes over up to one year, tracking changes in quality of life and any therapeutic benefits or adverse effects linked to cannabis. Researchers monitor these factors through patient reports and medical evaluations to better understand the impact of cannabis in this patient group.

Researchers are evaluating the effectiveness and safety of SP-624 compared to a placebo in adults aged 18 to 65 with moderate to severe Major Depressive Disorder (MDD). This Phase 2B study focuses on treating this condition and assesses changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 4. Participants receive either SP-624 or a placebo once daily. The SP-624 treatment consists of two capsules taken orally each day, providing a total dose of 20 mg. Those in the placebo group take two matching placebo capsules daily. The study is designed as a multi-center, double-blind, randomized, placebo-controlled trial. During the study, participants will be monitored for changes in depression severity through the MADRS assessment from the start of the study to week 4. Researchers will also evaluate safety and tolerability throughout the treatment period. The total study duration and specific follow-up details are not provided but include careful observation of participants' health and response to treatment.

Researchers are evaluating the safety of an investigational chickenpox (varicella) vaccine compared to an already approved vaccine called Varivax. This Phase 3 study involves healthy children aged 12 to 15 months who have not had chickenpox or received a varicella vaccine before. The goal is to assess how well children tolerate the new vaccine in comparison to the existing one. Participants will receive a single dose of either the investigational varicella vaccine or the marketed Varivax vaccine, both given by injection under the skin. Alongside, children may also receive one dose of measles, mumps, and rubella vaccine, hepatitis A vaccine, and one of several pneumococcal conjugate vaccines depending on the country’s recommendations and availability. These co-administered vaccines are given either under the skin or into the muscle. The study carefully follows national immunization guidelines regarding pneumococcal vaccines. During the study, researchers will monitor children for side effects at the injection site and systemic reactions such as fever, tracking these from the day of vaccination up to 43 days or longer depending on the event type. Safety is further assessed by recording any adverse events, medically attended events, and serious adverse events up to 181 days after vaccination. Parents will complete diaries and attend follow-up visits to help gather this information, ensuring thorough monitoring of the vaccine’s safety and tolerability.

Bipolar disorder is a serious and long-lasting mood disorder affecting both adults and children, with up to 1.8% of the pediatric population in the United States affected. Treatment options for depressive episodes in children with bipolar disorder are limited due to fewer studies compared to adults. This research aims to evaluate how cariprazine affects disease symptoms and safety in children and teenagers aged 10 to 17 years who have bipolar I disorder with depressive episodes. Participants in the study will be randomly assigned to one of two groups: one receiving cariprazine and the other receiving a placebo, with about half of the participants in each group. Cariprazine will be given as oral capsules in doses adjusted based on age and weight. At the third week, doses may be increased for those not responding well, while others will continue their current dose. The treatment lasts 6 weeks, followed by a 4-week safety follow-up period. During the study, participants will attend weekly visits to hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure changes in depression scores and monitor for any adverse events or abnormal clinical signs, including vital signs, ECG, and movement disorders. The total study duration includes the treatment and safety follow-up periods, ensuring careful observation of participants' health and response to treatment.

Researchers are evaluating the potential of GB-0895 as an additional treatment for adolescents and adults with severe asthma that is not controlled by inhaled corticosteroids and other standard asthma treatments. This global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study includes a main treatment phase and an optional open-label extension to assess the drug's safety and effectiveness over time. Participants will be randomly assigned to receive either GB-0895 or a placebo given by subcutaneous injection every six months for 52 weeks. The study is organized into several phases: screening and baseline, run-in, treatment, and follow-up, with an optional open-label extension lasting beyond the initial treatment period. During the extension, additional doses of GB-0895 will be administered at weeks 52 and 78. Throughout the study, participants will attend visits every one to two months after the first month for assessments and monitoring. Researchers will evaluate the annualized rate of asthma exacerbations from the start of treatment to week 52. Safety and health outcomes will be closely monitored through physical exams, lung function tests, questionnaires, and other clinical assessments. Total participant involvement can last up to 142 weeks if they join the extension phase.

Researchers are evaluating the safety and effectiveness of solriamfetol in adults aged 18 to 55 who have been diagnosed with binge eating disorder (BED) according to DSM-5 criteria. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how solriamfetol affects BED by comparing it to a placebo over 12 weeks. Participants will be randomly assigned to one of three groups receiving either solriamfetol 150 mg, solriamfetol 300 mg, or a placebo. All treatments are given once daily during the 12-week study period. The study carefully monitors the impact of these treatments on the number of binge eating episodes. Throughout the study, participants will be assessed for changes in binge eating behavior from the beginning to the end of the 12 weeks. Safety and adherence to treatment will also be monitored. Participants provide written informed consent before starting and are regularly evaluated to ensure compliance and well-being during the trial.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the effects of lumateperone compared to a placebo in children and teens aged 10 to 17 who are experiencing major depressive episodes linked to bipolar I or bipolar II disorder. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to understand how well lumateperone works and how safe it is in this young population. Diagnoses are confirmed using a structured clinical interview based on DSM-5 criteria. The study includes three phases: a screening period of up to 2 weeks to check if patients qualify, a 6-week double-blind treatment phase where participants are randomly assigned to take either lumateperone or a matching placebo once daily by mouth, and a 1-week safety follow-up after the last dose for health monitoring. Lumateperone is given orally once a day, and the placebo group receives a matching oral pill on the same schedule. Participants will attend clinic visits for assessments including the Children's Depression Rating Scale-Revised (CDRS-R) measured at week 6 to evaluate depressive symptoms. Safety follow-up occurs about one week after treatment ends. Throughout the study, researchers monitor symptoms, side effects, and overall health to assess the treatment's impact and safety over the 7 to 9 week total participation time including screening and follow-up.

Researchers are evaluating the safety and effectiveness of lumateperone in treating irritability associated with Autism Spectrum Disorder (ASD) in children and adolescents aged 5 to 17 years. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study includes participants diagnosed with ASD and confirmed irritability symptoms using standard diagnostic tools. The study consists of three phases: a screening period lasting up to 14 days to check eligibility, a 6-week double-blind treatment period where participants will be randomly assigned to receive either a high dose of lumateperone, a low dose of lumateperone, or a placebo once daily, and a 1-week safety follow-up period after the last dose to monitor participants' well-being. During the study, participants will be monitored for changes in irritability using the Aberrant Behavior Checklist - Irritability subscale at week 6. Safety evaluations will occur during the follow-up visit approximately one week post-treatment. Throughout the trial, assessments will include clinical evaluations and caregiver reports to track symptoms and any side effects, ensuring participant safety over the approximately seven-week participation period.

Researchers are evaluating the safety and tolerability of lumateperone in children and adolescents aged 5 to 17 years with schizophrenia, bipolar disorder, or autism spectrum disorder. This global, multicenter, open-label Phase 3 study includes both new patients and those rolling over from previous lumateperone studies or lead-in efficacy studies. The conditions studied are confirmed using standardized diagnostic tools, and participants must generally be outpatients expected to remain so during the study. Participants will receive lumateperone once daily in doses ranging from 5 mg to 42 mg, provided as capsules or orally disintegrating tablets, adjusted by age and condition. The study includes a screening period of up to two weeks to determine eligibility, followed by a 26-week open-label treatment phase where all patients receive lumateperone. After treatment, there is a two-week safety follow-up period to monitor any lasting effects or adverse events. During the study, participants will be monitored for common adverse events up to six months. The study involves regular assessments to ensure safety and tolerability, including evaluation for suicidal risk and maintenance of outpatient status. Parents or guardians provide consent while participants provide assent. The total participation lasts approximately 30 weeks, including screening, treatment, and follow-up.