Cromwell

Researchers are evaluating azetukalner as a monotherapy in adults diagnosed with moderate-to-severe Major Depressive Disorder (MDD). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the clinical efficacy, safety, and tolerability of azetukalner compared to placebo. Participants must be adults between 18 and 74 years old, experiencing a current major depressive episode confirmed by standard diagnostic criteria and lasting between 6 weeks and 24 months. Participants are randomly assigned to receive either azetukalner 20 mg or a placebo, both taken orally once daily with food (preferably with the evening meal) for 6 weeks. The study compares these two groups to determine the impact of azetukalner on depressive symptoms. The trial maintains double-blinding to ensure unbiased assessment of outcomes. During the study, participants undergo regular assessments including evaluations of depressive symptoms using the Hamilton Depression Rating Scale (HAMD-17) at baseline and at Week 6. Safety and tolerability are monitored throughout the treatment period. The total participation time corresponds to the 6-week treatment phase, during which symptom changes and adverse events are closely observed.

Researchers are evaluating the effects of SPT-300 (GlyphAllo), a prodrug of allopregnanolone, in adults aged 18 to 65 years who have major depressive disorder (MDD), with or without anxious distress. This Phase 2 study is randomized, double-blind, placebo-controlled, and aims to assess the efficacy, safety, and tolerability of SPT-300 as a monotherapy treatment for MDD. Participants will receive either SPT-300 or a placebo and will be monitored over a 42-day treatment period. The study compares the impact of SPT-300 to placebo on depressive symptoms and any side effects experienced. The intervention is given as a drug treatment, and participants are randomly assigned to one of the two groups. Throughout the study, researchers will measure changes in depression severity using the Hamilton Depression Rating Scale-17 (HAM-D-17) total score from the start of the treatment to day 42. Participants will be assessed for safety and tolerability, and their adherence to treatment will be monitored. The study focuses on the depressive episode lasting between 4 weeks and 18 months, with careful screening to ensure participant eligibility and safety.

Researchers are evaluating 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. This open-label extension (OLE) study is designed to continue monitoring these participants to understand the lasting impact of ORKA-001 treatment. The study is in Phase 2 and focuses on adults who have completed the prior trial successfully. Participants will receive ORKA-001 through subcutaneous injections during an open-label treatment period lasting up to about 96 weeks. After this, there is a post-treatment follow-up period of approximately 48 weeks following the last study visit to observe any ongoing effects or safety concerns. This design helps researchers gather detailed long-term data on the medication. Throughout the study, participants will be regularly assessed for any treatment-emergent adverse events, especially those of special interest, from the first day through week 144. Safety, tolerability, and efficacy evaluations will be conducted, including medical exams and laboratory tests. Participants will be monitored closely to ensure their well-being and to collect comprehensive data on the treatment's impact over time.

Researchers are conducting a multicenter, randomized, double-blinded, placebo-controlled study to find the best dose of ORKA-002 for adults with moderate-to-severe plaque psoriasis. The study aims to evaluate the effectiveness and safety of ORKA-002 compared to a placebo. Approximately 160 adult participants diagnosed with plaque psoriasis for more than 6 months, who are candidates for systemic therapy or phototherapy, will take part in this Phase 2 trial. Participants will receive one of three induction dosing regimens of ORKA-002 or a placebo, both administered by subcutaneous injection. The study consists of three periods: a screening period, an induction period where treatment is given, and a post-treatment follow-up period to monitor outcomes and safety. The goal is to identify the optimal dosing regimen that provides the best balance of efficacy and safety. During the study, participants will be assessed for the proportion achieving complete clearance of psoriasis skin symptoms (100% reduction in PASI score) by week 16. Researchers will also monitor for any treatment-emergent adverse events or serious side effects through week 48. Participants will undergo various evaluations including clinical assessments and safety monitoring throughout the study duration.

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 conducting a Phase 3, double-blind, placebo-controlled study to evaluate the effectiveness and safety of AXS-14 (Esreboxetine) in treating fibromyalgia. The study aims to understand how well AXS-14 manages fibromyalgia symptoms and maintains therapeutic response over time. The study includes a 12-week open-label treatment period where all participants receive AXS-14 tablets once daily. Participants who respond to this treatment are then randomly assigned in a 1:1 ratio to either continue taking AXS-14 or switch to placebo tablets once daily for another 12 weeks. This randomized withdrawal period continues until 12 weeks or until a loss of therapeutic response occurs. Participants will be involved in the study for at least 24 weeks, including both treatment phases. Researchers will monitor the time from randomization to loss of therapeutic response as the primary outcome. Assessments will include safety evaluations and adherence to medication, with regular follow-ups to track symptom management and treatment effects throughout the study.

Researchers are evaluating the long-term safety of rimegepant for treating acute migraine in children and adolescents aged 6 to under 18 years. This Phase 3, open-label study focuses on young individuals with a history of migraine with or without aura, aiming to understand the safety and tolerability of this treatment over time. Participants receive rimegepant orally in doses of 75 mg, 50 mg, or 35 mg orally disintegrating tablets (ODT) as needed for migraine attacks. The study monitors treatment over an extended period to assess ongoing safety and tolerability in a pediatric population. Throughout the study, participants will be regularly evaluated for any adverse effects, including serious events, events leading to discontinuation, and significant lab abnormalities. Safety assessments are conducted over 58 weeks, with careful monitoring to ensure participant well-being and collect comprehensive safety data.

This research aims to evaluate the long-term safety and tolerability of NBI-1065845 when added to ongoing antidepressant treatment in adults diagnosed with Major Depressive Disorder (MDD). It focuses on participants who have experienced moderate or severe recurrent MDD or persistent depressive disorder and who have not responded adequately to oral antidepressants during their current depressive episode. This is a Phase 3, open-label study designed to monitor the effects of this adjunctive treatment over an extended period. Participants will receive NBI-1065845 tablets alongside their current oral antidepressant therapy. The study will observe treatment effects and monitor any adverse events that emerge during the course of therapy. There is no mention of a comparator or placebo group, indicating all enrolled individuals will be treated with NBI-1065845 in addition to their existing medication. The treatment and observation period extends through 52 weeks, allowing for comprehensive long-term safety assessment. During the study, participants will be regularly evaluated for treatment-emergent adverse events from the start through week 52. Researchers will track safety and tolerability through clinical assessments and monitoring. Participants must be willing and able to follow all study procedures and restrictions as determined by the investigators. The overall duration and detailed assessments ensure thorough monitoring of how well participants tolerate the adjunctive treatment over the course of one year.

Researchers are evaluating the effectiveness of NBI-1065845 compared to a placebo as an additional treatment for people with Major Depressive Disorder (MDD). The study focuses on participants who have moderate to severe depressive symptoms and have not responded adequately to oral antidepressant treatments during their current episode. This is a Phase 3 trial aiming to improve symptoms of depression by adding NBI-1065845 to existing antidepressant therapy. Participants will receive either NBI-1065845 tablets or matching placebo tablets alongside their current oral antidepressant medication, which they must continue at the same dose and frequency. The study compares these two groups to assess the added benefit of NBI-1065845 as an adjunctive therapy. During the study, participants will be assessed for changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and on Day 56. Researchers will monitor safety and efficacy throughout the study period. Participants must comply with all study procedures and restrictions, with the total participation duration covering at least 56 days to evaluate treatment effects.

This research aims to test the safety and effectiveness of BHV-3000 (rimegepant) compared to a placebo for treating moderate to severe migraine attacks in children and adolescents aged 6 to under 18 years. The study focuses on pediatric migraine, including attacks with or without aura, lasting more than 3 hours and occurring 1 to 8 times per month over the previous two months. Participants must be able to clearly distinguish migraine from other headaches and weigh more than 40 kg. Participants will receive either BHV-3000 (rimegepant) at doses of 75 mg or 50 mg as an orally disintegrating tablet (ODT) or a matching placebo. The study is randomized, double-blind, and placebo-controlled, designed to evaluate the acute treatment effect. Some participants may continue stable migraine preventive medications, but use of CGRP antagonist drugs is not allowed. The treatment phase will monitor responses to the study drug during migraine attacks. During the study, participants will be assessed for migraine pain relief two hours after dosing, measuring how many experience complete freedom from pain. Blood samples will be taken, and participants will be monitored for safety and side effects. The study excludes those with certain headache types, significant psychiatric or neurological conditions, recent surgeries, or other serious medical issues that could affect participation or safety. Overall, the study evaluates both the effectiveness and safety of rimegepant in a pediatric population over the course of migraine attacks.