INFO at: https://clinicaltrials.gov
Trial #: NCT06568367
TITLE: A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated with Shift Work Disorder
Brief Summary
SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD).
Detailed Description
Eligible subjects must meet the International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD). Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol titrated to either 150 mg, 300 mg, or placebo once per night shift for 12 weeks.
Inclusion Criteria:
Exclusion Criteria:
TO SEE IF YOU QUALIFY PLEASE GO TO THE
Trial #: NCT05869773
TITLE: A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
Brief Summary:
The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to XYWAV, a low-sodium oxybate. The results of this study may provide healthcare providers (HCPs), patients, and payers with important new information regarding BP changes related to differences in sodium content between available oxybates for the treatment of narcolepsy.
Detailed Description
Not Provided
Key Inclusion Criteria:
Key Exclusion Criteria:
TO SEE IF YOU QUALIFY PLEASE GO TO THE
Trial #: NCT06358950
TITLE: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (Vibrance-1)
Brief Summary:
The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.
Eligibility Criteria:
Inclusion Criteria:
Exclusion Criteria:
TO SEE IF YOU QUALIFY PLEASE GO TO THE
INFO at: https://clinicaltrials.gov
Clinical Trial #: NCT05813275
TITLE: Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)
Brief Summary
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
Detailed Description
Not provided
Inclusion Criteria:
Exclusion Criteria:
Trial #: NCT05875974
TITLE: A Prospective, Open-Label, Single-Arm, Multicenter Study to Evaluate the Effect of Low-Sodium Oxybate Oral Solution (XYWAV) on Sleepiness, Polysomnography, and Functional Outcomes in Adult Participants Aged 18 to 75 Years With Idiopathic Hypersomnia or Narcolepsy
Brief Summary:
This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.
Detailed Description
This prospective, multicenter, single-arm, open-label interventional study will assess the safety and efficacy of JZP258 on sleepiness, polysomnography measurements (eg, sleep stage transitions, sleep patterns, and sleep quality), daytime and nighttime symptoms, pharmacokinetics (in narcolepsy), and patient-reported outcomes that include subjective sleep quality and quality of life in patients with IH or narcolepsy.
Trial #: NCT05882045
TITLE: A Study Investigating the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants with Severe Obesity and Established Cardiovascular Disease
Brief Summary:
Study GZBM is a Phase 3, randomized, double-blind, parallel-arm, placebo-controlled study to investigate the efficacy and safety of LY3437943 in participants with severe obesity and established CV disease.
Study GZBM is a study to evaluate the efficacy and safety of LY3437943 in participants with severe obesity and established cardiovascular disease with or without T2D.
This study will investigate the impact of LY3437943 on cardiovascular events and contribute to a cardiovascular meta-analysis across Phase 2 and 3 studies. Study GZBM is designed to achieve at least 88 adjudicated major adverse cardiac events to demonstrate that LY3437943 is not associated with excessive cardiovascular risk.
The study duration will be approximately 113 weeks including screening and follow-up.
The treatment duration will be approximately 104 weeks.
The visit frequency will be every 4 weeks.
INFO at: https://clinicaltrials.gov
Trial #: NCT04652882
TITLE: Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
Brief Summary
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and a matching placebo in male and female participants with DSWPD.