Woodbury

Researchers are evaluating the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment compared to no stimulation in people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, blinded trial focuses on reducing depressive symptoms over 12 months using multiple depression rating scales. The study follows guidelines from the Centers for Medicare and Medicaid Services regarding evidence development for this treatment. Participants receive implantation of the VNS device, which delivers stimulation to the vagal nerve. After a minimum two-week period post-implantation, participants are randomly assigned to either active VNS treatment or no stimulation control, with outcomes observed for 12 months. Following this randomized phase, all participants enter an open-label extension where those in the control group receive active stimulation. Additional subjects may join this open-label study for up to five years to further assess long-term effects. Throughout the study, participants undergo regular assessments including the Montgomery Åsberg Depression Rating Scale (MADRS), WHO Disability Assessment Schedule, Health Outcome Scale, Clinical Global Impressions Scale, and Suicidality Tracking Scale. Researchers monitor response rates, remission times, duration of effects, and adverse events from implantation through 12 months. This comprehensive evaluation includes safety monitoring and functional outcome measures to understand the impact of VNS therapy on depression and related disabilities.

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that blocks multiple pro-inflammatory cytokines involved in atopic dermatitis. This phase 2, double-blind, placebo-controlled study focuses on adults with moderate to severe atopic dermatitis that has not responded adequately to topical treatments. Participants are observed over approximately 36 to 40 weeks to compare BFB759 with a placebo. Participants are randomly assigned to receive either BFB759 or a placebo, with dosing aimed at assessing different levels of the drug's effects. The study is designed as a parallel-arm trial, meaning groups receive different treatments simultaneously without crossover. The investigational drug targets key inflammatory pathways believed to drive symptoms in atopic dermatitis. During the study, participants attend regular visits for monitoring and assessments. Researchers evaluate the drug's efficacy at 16 and 32 weeks using specific outcome measures. Safety is closely monitored throughout the treatment period. Participants are also expected to follow study instructions, avoid certain medications, and complete all scheduled visits during the study duration.

Researchers are evaluating the efficacy and safety of different dose regimens of IMG-007 compared to placebo in adult participants with moderate-to-severe active atopic dermatitis. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will last up to 52 weeks and aims to find the best dosing strategy for this condition. Participants will receive either IMG-007 or a placebo by subcutaneous injection. The study involves multiple dose regimens to assess how well IMG-007 works and how safe it is. Participants will be randomly assigned to one of the treatment groups, and both participants and researchers will be unaware of the treatment assignment to ensure unbiased results. During the study, participants will be monitored regularly with assessments including the Eczema Area and Severity Index (EASI) to measure skin condition changes, focusing on the mean percent change from baseline at Week 20. Safety will also be closely tracked throughout the study. The total participation period may extend up to 52 weeks, allowing for thorough evaluation of treatment effects and safety over time.

This research aims to evaluate the safety and effectiveness of ruxolitinib cream in children aged 2 to 11 years with nonsegmental vitiligo, a condition that causes loss of skin color in patches. The study is a Phase 3 trial focusing on this pediatric population to better understand how well the treatment works and how safe it is for young patients. Participants will be randomly assigned to receive either ruxolitinib cream or a matching vehicle cream, both applied as a thin layer twice daily to the affected skin areas. The treatment is topical and focuses on areas of skin depigmentation, including the face and other body parts. The study measures progress over 24 weeks to determine the proportion of participants who achieve significant improvement in facial vitiligo. Throughout the study, participants will have regular assessments including skin evaluations and safety monitoring. Researchers will track changes in the affected skin areas using the Facial Vitiligo Area Scoring Index. Participants must stop all other vitiligo treatments before starting and during the study. Safety follow-ups will continue after treatment to ensure participant well-being and gather comprehensive data on treatment effects.

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 a novel bioactive leg sleeve compared to a placebo sleeve on pain and patient-reported outcomes after arthroscopic meniscectomy or meniscus repair. This randomized, blinded prospective study aims to determine if the bioactive sleeve can reduce pain and improve recovery faster and more reliably than a regular sleeve. Approximately 100 patients undergoing meniscus surgery will participate, with assessments focused on pain levels and functional outcomes over two years. The study involves two groups: one using the Reparel Sleeve, which contains technology designed to reflect and absorb thermal energy to release photonic energy that may reduce pain and inflammation while promoting healing; and a control group using a placebo sleeve with similar look, feel, and compression but no active technology. Participants will wear their assigned sleeve postoperatively and follow a rehabilitation regimen while researchers monitor their progress. Participants will complete several patient-reported outcome measures (PROMs) including the Visual Analogue Scale (VAS) for pain, KOOS JR, VR12, and KSS Satisfaction before surgery and at multiple time points after surgery, including 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Physical therapy time and motor function will also be assessed. The primary outcome is the VAS pain score measured over two years, with ongoing safety and effectiveness monitoring throughout the study duration.

Researchers are evaluating how well seltorexant works and its safety as an added treatment to antidepressants in adults and elderly participants who have major depressive disorder with insomnia symptoms (MDDIS). The study focuses on people who have not responded adequately to current antidepressant therapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This Phase 3 trial aims to assess the improvement of depressive symptoms and the maintenance effect of seltorexant compared to a placebo. Participants will receive either seltorexant or a matching placebo taken orally alongside their current antidepressant medication, which includes SSRIs or SNRIs. The study is divided into two parts: Part 1 evaluates changes in depression severity after 43 days, while Part 2 monitors the time to relapse for up to nearly three years in participants who achieved a stable response. Participants must continue their stable antidepressant dose during the study. During the study, participants will be assessed using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms and monitored for relapse over time. Safety and tolerability will also be evaluated throughout. The total participation includes an initial treatment phase and an extended maintenance phase, allowing researchers to understand both short-term and long-term effects of seltorexant as an adjunctive therapy.

Researchers are evaluating the safety and effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) device for treating moderate to severe Alcohol Use Disorder (AUD) in adults aged 18 to 86 years. This is a prospective, double-blind, randomized, controlled trial conducted over 6 months at multiple academic and private research centers. The study compares active Deep TMS treatment to a sham (inactive) treatment to assess their impacts on alcohol use, specifically focusing on reducing heavy drinking days. Participants are randomly assigned to receive either the Deep TMS treatment or the sham treatment in a 1:1 ratio. The acute treatment phase lasts 3 to 5 weeks with 15 visits, each including two treatment sessions per visit spaced 30 minutes apart. Following this, there is a maintenance and follow-up phase with one treatment session per week until the 6-month follow-up visit. During each treatment session, participants are exposed to alcohol-related cues before receiving either active or sham Deep TMS stimulation. Throughout the study, participants undergo various assessments including surveys on alcohol consumption and craving, physical and neurological exams, and safety monitoring for adverse events and vital signs. The main outcome measured is the proportion of participants who achieve zero heavy drinking days between months 2 and 4. The total study duration for participants is approximately 6 months, including initial screening, treatment, maintenance, and follow-up evaluations.

Researchers are evaluating the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have severe alopecia areata with 50% or more scalp hair loss. This Phase 3 study includes participants with a current alopecia areata episode lasting between 6 months and 10 years. The goal is to assess how well deuruxolitinib works compared to a placebo in improving hair regrowth and to monitor its safety in this age group. Participants will be randomly assigned to receive either oral deuruxolitinib tablets at a dose of 8 mg or matching placebo tablets during a 24-week double-blind treatment period. After this period, all participants can join an open-label extension lasting 52 weeks, during which they will receive deuruxolitinib. This design allows researchers to evaluate the drug's effects over both the initial treatment and a longer-term period. Throughout the study, participants will undergo evaluations including measuring scalp hair loss using the Severity of Alopecia Tool (SALT) score, monitoring for adverse events, checking vital signs, conducting electrocardiograms, lab tests, and physical exams. The main outcome is the percentage of subjects achieving a SALT score of 20 or less at week 24. Safety and tolerability will also be assessed throughout the 24 weeks. Participants are expected to comply with study visits and procedures during the entire study duration.