Draper

Researchers are evaluating the long-term safety and tolerability of intermittent use of elismetrep in adults who experience acute migraine attacks. This Phase 3 study aims to monitor adverse events and overall safety during an average of one year of treatment. The study is conducted by Kallyope Inc. and compares two doses of elismetrep with a placebo using a randomized, triple-blind design. Participants will receive oral doses of elismetrep at either 10 mg or 20 mg, or a matching placebo. The study focuses on intermittent use during acute migraine episodes. Participants must have completed a prior acute treatment trial of elismetrep and meet compliance criteria. Treatment and assessments continue through the study duration, averaging one year. During the trial, participants will be monitored for any treatment-emergent adverse events, serious adverse events, and events leading to discontinuation. They will use a personal smartphone to complete eDiary check-ins and questionnaires, including assessments at 2 and 4 hours post-dose during migraine attacks. Safety and tolerability data will be collected throughout, with study participation lasting approximately one year.

Researchers are conducting a Phase 3 clinical trial to evaluate the drug DT120 compared to placebo in adults aged 18 to 74 years diagnosed with Major Depressive Disorder MDD. Participants must have a confirmed diagnosis according to the DSM-5, be experiencing a major depressive episode lasting between 8 weeks and 24 months, and have certain minimum scores on depression severity scales. The study aims to assess the efficacy and safety of DT120 in treating MDD symptoms. The study includes a 12-week randomized, double-blind period where participants receive a single dose of either DT120 or placebo. After this, eligible participants can enter a 40-week open-label extension phase where all receive DT120 and are monitored for safety and symptom changes, with the possibility of retreatment based on specific criteria. The study drug works mainly through serotonin 2A receptor activity. Participants will undergo various assessments throughout the study, including regular evaluations of depression severity using the Montgomery-sberg Depression Rating Scale MADRS, Clinical Global Impression scales, anxiety rating, quality of life questionnaires, and sexual functioning assessments. The primary outcome is the change in MADRS score at Week 6. Safety and treatment needs will also be monitored during the extension phase. Total participation may last up to 52 weeks, with ongoing monitoring of mood and symptom changes.

Researchers are evaluating the efficacy, safety, and tolerability of VLS-01 buccal film VLS-01-BU in adults with treatment resistant Major Depressive Disorder TRD. This Phase 2, multicenter, randomized, placebo-controlled trial aims to understand the onset and duration of antidepressant effects of VLS-01-BU compared to placebo in patients who have not responded to previous treatments. Participants will be randomly assigned to receive two doses of either VLS-01-BU or placebo administered via a buccal transmucosal film, with two weeks between doses. After a 12-week follow-up monitoring period, all participants will be re-randomized to receive one additional dose of VLS-01-BU at one of two dose strengths. Safety and efficacy will be assessed two weeks after this third dose during a non-placebo-controlled treatment phase. Throughout the study, participants depressive symptoms will be regularly monitored using the Montgomery-sberg Depression Rating Scale MADRS from baseline to Day 29 and through Day 43. The study includes multiple assessments to measure the antidepressant effects and safety of the treatment. The total duration of participant involvement covers the initial dosing, follow-up, re-randomization, and final evaluation, ensuring thorough observation of treatment impact and tolerability.

Researchers are evaluating the effects of elismetrep, an oral drug, compared with a placebo for the acute treatment of migraine in adults aged 18 to 75. This phase 3, double-blind, randomized study is conducted at multiple centers to assess the drugs safety, tolerability, and effectiveness in relieving migraine symptoms quickly. Participants receive either 10 mg or 20 mg of elismetrep or a placebo orally as part of the trial. The study uses a parallel design where participants are randomly assigned to one of these groups and neither the participants nor the researchers know which treatment is given until the study ends. During the trial, participants will be monitored for migraine pain relief and freedom from bothersome symptoms two hours after dosing, among other outcomes. Researchers will also assess pain relief at various time points, use of rescue medication, and safety by tracking any adverse events. Participants will complete questionnaires and use an eDiary app to record their experiences. The study is expected to last until February 2027.

Researchers are evaluating the effectiveness of NBI-1065845 compared with a placebo as an additional treatment to delay the return of depressive symptoms in people with major depressive disorder MDD. This Phase 3 study focuses on maintaining the treatment effect in participants diagnosed with recurrent moderate or severe MDD or persistent depressive disorder who have not fully responded to oral antidepressants. Participants first receive NBI-1065845 during an open-label treatment period. Then, in a randomized, double-blind phase, participants are assigned to either continue NBI-1065845 or switch to a matching placebo. The study uses oral tablets for both NBI-1065845 and placebo treatments and follows a parallel study model. Throughout the trial, participants will be monitored for relapse of depressive symptoms using the Hamilton Depression Rating Scale and other assessments. The primary outcome is the time from randomization until relapse or study end, lasting up to approximately 32 months. Participants must continue their antidepressant treatments at the same dose during the study and comply with all procedures and restrictions. Safety and adherence are closely observed by the investigators during the entire study period.

Researchers are evaluating a new form of LASIK called Ray Tracing Guided LASIK by comparing it to three other types of corneal refractive surgery 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. The study focuses on patients with myopia or myopia with astigmatism and aims to compare visual outcomes across these different technologies in a prospective, randomized design. This study is conducted in three phases, each including at least 44 participants who undergo surgery for refractive correction. In each phase, patients will have one eye treated with Ray Tracing Guided LASIK and the other eye treated with one of the three comparator procedures. The surgeries use specific laser devices and technologies tailored to each method. Participants will receive routine postoperative care and medications as per standard practices. Participants will attend follow-up visits at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery. At several visits, including screening and postoperative timepoints, patients will complete questionnaires about their experience. Researchers will measure uncorrected visual acuity at 3, 6, and 12 months as the main outcome. Additional assessments include predictability of vision correction. Retreatments are allowed only after all study visits are completed or the subject has left the study.

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 study aims to understand how patient characteristics influence the drugs effectiveness when added to a mood stabilizer andor atypical antipsychotic treatment. The study also assesses safety, tolerability, and efficacy during an open-label treatment phase following the initial blinded period. Participants will be randomly assigned to receive either ALTO-100 40 mg tablets or a matching placebo twice daily for six weeks during the double-blind phase. Those who qualify and continue into the open-label phase will receive ALTO-100 40 mg tablets twice daily for up to seven additional weeks. The study involves careful monitoring of depressive symptoms using standardized rating scales and safety evaluations throughout both study periods. During the trial, participants will undergo regular assessments including the Montgomery-sberg Depression Rating Scale MADRS, Patient Health Questionnaire PHQ-9, and Clinician Global Impression Scale-severity CGI-S. Safety monitoring covers adverse events, vital signs like heart rate and blood pressure, weight, and suicidality using the CHRT-SR12 scale. The total study duration for each participant can extend up to 13 weeks, with close follow-up to evaluate treatment effects and safety.

Researchers are evaluating the safety and effectiveness of TSND-201 in adults diagnosed with Post Traumatic Stress Disorder PTSD who have had symptoms for at least six months. The study involves participants who have previously tried at least one medication or trauma-focused psychotherapy for PTSD. This phase 3 randomized, double-blind, placebo-controlled trial aims to compare two doses of TSND-201 capsules with a placebo to better understand treatment options for PTSD. Participants will enter a 4-week Treatment Period during which they will be randomly assigned to receive either one of two doses of TSND-201 or a placebo capsule once a week, taken orally. After completing this treatment phase, they will continue into an 8-week Follow-up Period to monitor their progress and any changes in their condition. The study uses a parallel design and masking to keep participants and researchers unaware of group assignments. During the study, participants will undergo assessments including the Clinician-Administered PTSD Scale for DSM-5 CAPS-5 to measure changes in PTSD severity from the start through 12 weeks. Researchers will also monitor safety and efficacy by evaluating participants regularly through interviews and questionnaires. The entire participation duration covers 12 weeks, including treatment and follow-up, with safety and response being closely observed throughout.

Researchers are evaluating the effects and safety of solriamfetol in adults with binge eating disorder BED. This Phase 3 trial compares two doses of solriamfetol 150 mg and 300 mg with a placebo to better understand their impact on BED symptoms. Participants must be aged 18 to 55 with a diagnosis of BED based on DSM-5 criteria. Participants will be randomly assigned to one of three groups receiving either solriamfetol 150 mg, solriamfetol 300 mg, or placebo tablets, all taken once daily for 12 weeks. This randomized, double-blind study will assess how these treatments affect binge eating episodes over the course of the trial. During the 12 weeks, participants will be monitored for changes in the number of binge eating episodes. Safety and efficacy will be evaluated through regular assessments. All study-related care, including medication and visits, will be provided at no cost, and the total participation duration is approximately 12 weeks.

This trial evaluates the safety and effectiveness of ARTIA Reconstructive Tissue Matrix in adult women undergoing immediate, two-stage implant-based breast reconstruction following mastectomy. The study focuses on participants having either unilateral or bilateral mastectomy and aims to assess outcomes related to breast reconstruction complications and participant satisfaction. Participants will receive breast reconstruction using the ARTIA Tissue Matrix device in a two-stage prepectoral implant-based procedure. The study is open-label, non-randomized, and conducted across multiple centers. The follow-up includes monitoring for major complications after the first stage and adverse events for up to approximately 36 months. Throughout the study, participants will be monitored for complications related to breast reconstruction, reconstructive failure, capsular contracture, and changes in satisfaction with breasts using the BREAST-Q score. Safety assessments and adverse event tracking will continue up to three years. The total study duration extends until February 2031, with primary outcome assessments at 18 months and secondary measures up to 36 months.