Draper

Researchers are evaluating the safety, tolerability, and effectiveness of VLS-01 buccal film (VLS-01-BU) as a short-term treatment for adults with treatment resistant Major Depressive Disorder (TRD). This Phase 2, multicenter, double-blind, randomized, placebo-controlled trial aims to compare antidepressant effects of VLS-01-BU against placebo, focusing on the onset and durability of these effects. About 142 participants with TRD will be randomly assigned in equal groups to receive two doses of either VLS-01-BU or placebo via buccal transmucosal administration, spaced two weeks apart. Following this placebo-controlled period, symptoms will be monitored for 12 weeks. Then, all participants will be re-randomized to receive a single additional double-blind dose of VLS-01-BU at one of two dose strengths during a non-placebo-controlled treatment phase. Safety and efficacy will be assessed two weeks after the third dose. Participants will be closely monitored throughout the study, including during the 12-week follow-up after the second dose and after the final treatment. Researchers will measure changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 29. Safety evaluations and tolerability assessments will also be conducted to understand the effects and duration of VLS-01-BU treatment.

Researchers are evaluating the effectiveness of NBI-1065845 compared to a placebo as an additional treatment to delay the return of depressive symptoms in adults with Major Depressive Disorder (MDD). This phase 3 study focuses on participants who have had moderate to severe recurrent MDD or persistent depressive disorder and have not responded adequately to oral antidepressant treatments. The goal is to maintain the positive effects of treatment and prevent relapse over a period of up to approximately 32 months. Participants receive either the study drug NBI-1065845 or a placebo in oral tablet form, both given alongside their ongoing oral antidepressant medications. They must continue their current antidepressant treatment at the same dose and frequency throughout the study. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the treatments. During the study, participants are monitored from the time of randomization until relapse or the study end, which may last up to 32 months. Researchers assess the time it takes for depressive symptoms to return, using measures such as the Hamilton Depression Rating Scale. Participants are expected to comply with all study procedures and restrictions, and safety monitoring is conducted throughout the study period.

Researchers are evaluating the visual outcomes of four different types of corneal refractive surgeries for people with myopia or myopia with astigmatism. The study compares a new form of LASIK called Ray-Tracing Guided LASIK to three other techniques: KeratoLenticule Extraction (KLEx) using the Zeiss Visumax 800 Laser, Wavefront Optimized LASIK (WFO LASIK) using the Alcon EX500 Laser, and Topography Guided LASIK (Contoura LASIK) also using the Alcon EX500 Laser. This prospective, randomized study is conducted in three phases, each with at least 44 participants, to compare Ray-Tracing LASIK with one of the other three methods.

Researchers are evaluating the antidepressant effects of ALTO-100 compared to a placebo in adults with Bipolar Disorder I or II who are currently experiencing a major depressive episode. This Phase 2 study focuses on patients who are also taking mood stabilizers and/or atypical antipsychotic medications. The study aims to understand differences in efficacy related to patient characteristics, while also assessing safety and tolerability. Participants will receive either ALTO-100 at a dose of 40 mg twice daily or a matching placebo tablet twice daily during the Double-Blind period. Following this, there will be an open-label treatment phase to further evaluate safety, tolerability, and effectiveness. All treatments are given alongside the patient’s existing mood stabilizer and/or atypical antipsychotic therapy. Throughout the study, participants will be regularly assessed for changes in depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) from Day 1 through Week 6. Researchers will monitor safety and tolerability during both the double-blind and open-label phases. The study involves ongoing compliance with assessments and procedures to track treatment effects and participant well-being.

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 the safety and effectiveness of Phentolamine Ophthalmic Solution in adults who have previously undergone keratorefractive surgery and experience reduced visual acuity in low light conditions. This phase 3 trial compares the effects of Phentolamine Ophthalmic Solution to a placebo to determine if the drug improves night vision. The study focuses on participants who report symptoms like glare, halos, or starbursts that began within two months after their surgery. Participants will be randomly assigned to receive either 0.75% Phentolamine Ophthalmic Solution or a placebo, both administered once daily for two weeks. During this period, participants will visit the clinic weekly for checkups and testing. They will also keep a daily diary to record when they apply the study medication each evening. Throughout the study, participants will undergo vision tests to measure changes in visual acuity under mesopic (low light) conditions. The main outcome is the percentage of participants who gain at least 15 letters (equivalent to 3 lines) improvement in vision at day 15 compared to the start. Researchers will monitor safety and collect data on any side effects. Participation involves regular clinic visits, vision assessments, and adherence tracking over the two-week treatment period.

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 whether a single dose of RE104 for Injection can reduce symptoms of depression or combined depression and anxiety in people diagnosed with Adjustment Disorder related to cancer or other serious illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD), or Idiopathic Pulmonary Fibrosis (IPF). This study is a Phase 2 trial comparing different doses of RE104 to an active placebo to assess safety and effectiveness. Participants will receive a single subcutaneous injection of RE104 at either 30 mg or 1.5 mg doses. The study uses a randomized, double-blind, parallel-group design to compare the impact of these doses on depressive symptoms. The treatment is given once, and participants are monitored to evaluate changes from baseline in depression rating scores by Day 7. During the study, participants will undergo clinical interviews to confirm eligibility and monitor symptoms. Researchers will assess depressive symptoms using the MADRS total score and track safety throughout the trial. Participants are expected to be ambulatory and capable of self-care to complete the study procedures, with adherence to study requirements closely monitored. The total participation duration includes baseline assessments and follow-up to Day 7 after dosing.

Researchers are evaluating the GalaFLEX LITE
22 Scaffold for its safety and effectiveness in revision surgery to reduce the recurrence of capsular contracture and/or implant malposition in women undergoing breast implant revision after augmentation. This prospective, randomized, controlled study compares the GalaFLEX LITE
22 Scaffold to standard surgery without supportive matrices or acellular dermal matrices (ADM). The study focuses on patients with Baker grade III or IV capsular contracture, a common complication after breast augmentation affecting 10 to 20% of patients. Participants will be randomly assigned in a 2:1 ratio to receive either the GalaFLEX LITE
22 Scaffold, a bioabsorbable surgical mesh made from poly-4-hydroxybutyrate designed to reinforce soft tissue, or standard surgery without any scaffold. The trial will include between 250 and 530 treated breasts and uses an adaptive design to assess outcomes. The primary endpoint includes recurrence of capsular contracture or implant malposition needing surgery, breast infections requiring antibiotics within 90 days, or peri-implant fluid collections needing drainage within 10 to 90 days post-surgery. During the study, participants will be followed for 24 months after their revision surgery. Researchers will monitor the stability of the implant pocket and assess complications through clinical evaluations. Participants will attend regular follow-up visits to track outcomes, safety, and any adverse events. The study aims to provide detailed information on the effectiveness of the GalaFLEX LITE
22 Scaffold in improving surgical outcomes and reducing common post-augmentation complications over a two-year period.

Menstrual migraine is a type of moderate to severe headache occurring around the time of menstruation, often accompanied by symptoms like nausea, vomiting, and sensitivity to light and sound. This trial evaluates the safety and effectiveness of ubrogepant, a drug being studied as a short-term preventive treatment for menstrual migraine. Adult women who experience migraine attacks in at least two out of three menstrual cycles are invited to participate in this Phase 3 study. Participants will be randomly assigned to receive either oral ubrogepant tablets or a placebo once daily for 7 consecutive days, starting 3 days before the expected start of their period, across three menstrual cycles during a 16-week double-blind treatment phase. Those who qualify may continue taking ubrogepant daily for 7 days per cycle during a 52-week open-label extension. The study involves about 496 women at around 100 sites across the United States and Puerto Rico. Throughout the study, participants will record daily information in electronic diaries and attend regular clinic visits. Researchers will monitor treatment effects through medical assessments, blood tests, questionnaires, and side effect checks. The main outcomes measured include changes in the number of migraine days during perimenstrual periods over 16 weeks and the number of participants experiencing adverse events up to approximately 68 weeks.