Cromwell

Researchers are evaluating azetukalner as a monotherapy in adults diagnosed with Major Depressive Disorder MDD in this Phase 3, multicenter, randomized, double-blind, placebo-controlled study. The trial aims to assess the clinical efficacy, safety, and tolerability of azetukalner compared to placebo in adults with moderate-to-severe MDD, focusing on changes in depression severity over a 6-week treatment period. Participants will receive either azetukalner 20 mg or a matching placebo, taken orally once daily with food, preferably with the evening meal, for 6 weeks. The study includes a screening period of approximately 4 weeks before baseline and monitors participants through 8 weeks after the final dose to assess safety. The trial is designed with two treatment arms and uses quadruple masking to ensure unbiased results. During the study, participants will undergo regular assessments including the Hamilton Depression Rating Scale HAMD-17 at baseline, Week 1, and Week 6, the Snaith-Hamilton Pleasure Scale SHAPS, and the Clinical Global Impression of Severity CGI-S scale. Safety and tolerability are evaluated throughout the study and follow-up periods by monitoring adverse events. Overall participation lasts from screening through 8 weeks post-treatment, with close attention to depression symptoms and participant well-being.

Researchers are studying the effects of SPT-300 GlyphAllo, a prodrug of allopregnanolone, in adults with major depressive disorder MDD, including those with or without anxious distress. This randomized, double-blind, placebo-controlled study aims to evaluate the drugs efficacy, safety, and tolerability in this population. The study is a Phase 2 trial designed to provide important information about SPT-300 as a monotherapy treatment for MDD. Participants will be randomly assigned to receive either SPT-300 capsules or a matching placebo once daily for 42 days. This parallel-group design ensures that both groups are treated similarly except for the active drug, allowing researchers to compare the effects accurately. The study focuses solely on monotherapy, meaning no additional antidepressant treatments are given during this period. During the trial, participants will be assessed at the start and after 42 days of treatment using the Hamilton Depression Rating Scale-17 HAM-D-17 to measure changes in depression severity. Safety and tolerability will also be monitored throughout the study. Additional evaluations include the Clinical Global Impression - Severity CGI-S scale to assess overall illness severity. The total participation time corresponds to the 42-day treatment period, with monitoring to ensure adherence and safety.

This research aims to evaluate the long-term safety and effectiveness of ORKA-001 in adults with moderate-to-severe plaque psoriasis who have previously participated in an Oruka Therapeutics sponsored study. The study is an open-label extension, focusing on adults who have completed a prior trial and seeks to monitor ongoing effects and safety over an extended period. Participants will receive ORKA-001 through subcutaneous injection following one of several dosing schedules once yearly at a high or low dose, twice yearly, or no drug until a specific response criterion is met. The treatment period can last up to approximately 96 weeks, followed by a post-treatment follow-up of about 48 weeks to observe longer-term outcomes. During the study, participants will be closely monitored for adverse events and treatment responses using measures like the Psoriasis Area and Severity Index PASI and Investigators Global Assessment IGA. Safety evaluations include tracking any serious or special interest adverse events throughout the study period. Participants will have regular visits for assessments, and the total involvement may span over three years, including treatment and follow-up.

Researchers are studying the effects of ORKA-002 in adults with moderate-to-severe plaque psoriasis. This multicenter trial is a randomized, double-blinded, placebo-controlled phase 2 study aiming to find the best induction dose of ORKA-002 to treat this skin condition. The study involves about 160 participants to evaluate both the effectiveness and safety of the medication compared to a placebo. Participants will be randomly assigned to receive one of three different dosing regimens of ORKA-002 or a placebo, with all treatments given by subcutaneous injection. The study includes a screening period to determine eligibility, an induction period where participants receive the assigned treatment, and a post-treatment follow-up period to monitor outcomes and safety. During the trial, participants will undergo assessments including skin evaluations using PASI and IGA scores to measure psoriasis severity and improvement. Safety will be closely monitored through reports of treatment-emergent adverse events up to 48 weeks. The total involvement includes screening, treatment, and follow-up to assess both short- and longer-term effects of ORKA-002.

Researchers are evaluating solriamfetol, a drug that affects TAAR-1, dopamine, and norepinephrine, for treating binge eating disorder BED in adults. This Phase 3 trial is randomized, double-blind, and placebo-controlled, designed to assess both the effectiveness and safety of solriamfetol in people diagnosed with BED according to DSM-5 criteria. Participants will be randomly assigned to one of three groups solriamfetol 150 mg, solriamfetol 300 mg, or placebo. Each participant will take their assigned tablets once daily for up to 12 weeks. The study compares these doses with placebo to understand the drugs impact on BED symptoms. During the 12-week treatment period, researchers will monitor changes in the number of binge eating episodes from the start of the study to week 12. Participants will also undergo assessments to check safety and adherence. The total duration of participation will be up to 12 weeks, during which the effects of the treatment will be carefully evaluated.

Researchers are evaluating the safety and effectiveness of AXS-14 esreboxetine in adults with fibromyalgia. This Phase 3 trial is designed to assess how well AXS-14 manages fibromyalgia symptoms through a randomized withdrawal approach. The study is double-blind and placebo-controlled to ensure unbiased results. Participants first enter a 12-week open-label treatment period where everyone receives AXS-14 tablets once daily. Those who respond to treatment during this phase are then randomly assigned in a 11 ratio to either continue taking AXS-14 or switch to placebo for another 12 weeks. This double-blind randomized withdrawal period lasts up to 12 weeks or until the participant loses their therapeutic response. Throughout the study, participants will be monitored for their response to treatment and safety. The main measure is the time from randomization to loss of therapeutic response during the 12-week double-blind period. Participants will provide informed consent and undergo study procedures as required. The total study duration for responders includes up to 24 weeks of treatment and observation.

Researchers are evaluating the long-term safety of rimegepant for the acute treatment of migraine in children and adolescents aged 6 to under 18 years. This study focuses on understanding how well rimegepant is tolerated and any side effects that may occur during extended use in this younger population with migraine, including those with or without aura. Participants will receive rimegepant orally in doses of 75 mg, 50 mg, or 35 mg as orally disintegrating tablets. This open-label study involves taking the medication as needed for migraine attacks over a period of up to 58 weeks, allowing researchers to observe safety and tolerability during regular use. Throughout the study, participants will be monitored for the frequency and severity of any adverse events, including serious side effects and those related to liver function. Blood samples will be collected, and migraine symptoms tracked to assess treatment impact. The study will last up to 58 weeks, with ongoing safety evaluations during this period to ensure careful observation of participant health.

Researchers are evaluating the long-term safety and tolerability of NBI-1065845 when added to usual treatment in adults with major depressive disorder MDD. This Phase 3 study focuses on participants who have struggled with moderate to severe recurrent or persistent depression and have not responded adequately to oral antidepressant treatments during their current depressive episode. Participants will take NBI-1065845 tablets orally once a day as an additional treatment. The study is open-label, meaning both participants and researchers know the treatment being administered. The main treatment period lasts up to 52 weeks, during which the safety and side effects of NBI-1065845 will be closely monitored. Throughout the study, participants will undergo regular evaluations to track any treatment-emergent adverse events. Researchers will assess how well participants tolerate the medication over time. Participants are expected to comply with study procedures and restrictions as determined by the investigators. The total participation duration is approximately one year, providing valuable long-term safety data for this adjunctive treatment in MDD.

Researchers are evaluating the effectiveness and safety of NBI-1065845 as an additional treatment in people with Major Depressive Disorder MDD, specifically those with moderate to severe depression or persistent depressive disorder who have not responded well to oral antidepressants. This Phase 3 study compares NBI-1065845 to a placebo to see if it improves symptoms of depression, focusing on reducing depression severity. Participants will receive either NBI-1065845 tablets or placebo tablets that look the same, taken orally once a day. They must continue their current oral antidepressant treatments at the same dose and frequency throughout the study. The study uses a randomized, double-blind, placebo-controlled design to fairly assess the effects of the treatments. During participation, individuals will be assessed at the start and after 56 days using measures such as the Montgomery-sberg Depression Rating Scale to track depression symptoms, the Sheehan Disability Scale to evaluate functional disability, and the Clinical Global Impression-Severity Scale. Researchers will monitor safety and treatment adherence while participants follow all study procedures. The study is expected to continue until July 2027.

Researchers are evaluating the safety and effectiveness of BHV-3000 rimegepant compared to a placebo for the acute treatment of moderate or severe migraine in children and adolescents aged 6 to under 18 years. This Phase 3 study focuses on those with a history of migraine lasting more than 6 months and experiencing 1 to 8 moderate or severe attacks per month. The goal is to measure relief from migraine pain and associated symptoms within hours after treatment. Participants receive either BHV-3000 rimegepant in doses of 75 mg or 50 mg orally disintegrating tablet ODT or a matching placebo. The study is randomized and double-blind, meaning neither participants nor researchers know who receives which treatment. Participants may continue one stable preventive migraine medication but cannot use CGRP antagonists. The treatment is given during migraine attacks, and effects are compared between the groups. During the study, participants will be closely monitored with assessments of migraine pain relief, freedom from the most bothersome migraine symptoms, and the need for rescue medication within 24 to 48 hours after dosing. Functional ability and symptom freedom such as photophobia, phonophobia, and nausea are also evaluated. The study involves blood sampling and requires participants to weigh over 40 kg. The research team tracks safety, treatment response, and overall migraine control through questionnaires and clinical evaluations over the study period.