compare clinical studies

This phase II clinical trial is a monocenter double-blind randomized placebo-controlled study to evaluate the efficacy and safety of solriamfetol from 75 to 300mg per day in idiopathic hypersomnia patients. Patients will be randomized to receive either solriamfetol or placebo with titration every morning upon awakening during all study treatment periods (day 0 to week 7). For more information call Dr. Yves Dauvilliers +33467335219 or email: y-dauvilliers@chu-montpellier.fr

The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets. It includes both double-blind treatment and open-label treatment periods. Study sites are still being selected. For more information email Alkermes at clinicaltrials@alkermes.com or call 888-235-8008.

This is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of FT218 with an open-label safety extension period. FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension. The study will enroll subjects who are diagnosed with idiopathic hypersomnia. Subjects will be eligible to enroll regardless of current treatment with oxybate therapy or stimulants/alerting agents at study entry. The estimated total duration of study for each subject is approximately 42 weeks, including the open-label safety extension period. For more information contact Avadel 636-449-1830 or email grichards@avadel.com.

The primary objective of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime sleepiness (EDS) as assessed by the Maintenance of Wakefulness Test (MWT) in adults with narcolepsy type 1 (NT). Clinical sites are still being selected. For more information please contact Eisai Medical Information at 888-274-2378 or email esi_medinfo@eisai.com

The aim of this study is to learn how effective TAK-861 is in improving excessive daytime sleepiness after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of cataplexy events in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, overall quality of life, the spectrum of narcolepsy symptoms and daily life functions. and to learn more about the safety of TAK-861. For more information about this study, please call 1-877-825-3327 or email medinfoUS@takeda.com.

The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms, and daily life functions; and to learn about the safety of TAK-861. For more information call 877-825-3327 or email medinfoUS@takeda.com

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 greater decrease in sleepiness and a decrease in cataplexy (sudden loss of muscle control) compared to participants taking placebo alone. Contact Alkermes Global Clinical Services by phone at 1-888-235-8008 or email clinicaltrial@alkermes.com to find out more about this study.

Low sodium oxybate has been approved by the US Food and Drug Association (FDA) for the treatment of idiopathic hypersomnia. In this study, the researchers want to learn how low sodium oxybate impacts the ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time. In addition, this study will use novel tools to determine when an individual is asleep or awake. Contact Clinical Trial Disclosure & Transparency at ClinicalTrialDisclosure@JazzPharma.com or by phone at 215-832-3750 for more information. OR click study number below to see individual sites and contact information.

The purpose of this multicenter double-blind study is to assess efficacy and safety of Pitolisant versus placebo in pediatric narcoleptic patients with or without cataplexy. It will be followed by a prolonged open-label period. For more information contact Bioprojet at www.bioprojet.com/en/contact-us/

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy Type 1 (NT1). Part 1 will evaluate safety, tolerability, and PK of MK-6552 after administration of ascending doses in a single day to support a dose level decision for Part 2. Part 2 will investigate the PD of MK-6552 after single-day and multiple-day administration. Participants who complete Part 1 and demonstrate that they are able to tolerate at least one dose level of MK-6552 will participate in Part 2. Contact trialsites@merck.com or call 888-577-8839 to find out more about this study. OR click study number below to see individual site contacts.

About this study: A Study to assess the Long-Term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects with Narcolepsy. This study is an open label extension that will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS). Click on the NCT link below for contact information by state. OR Contact the Study Director at: SYMPHONYstudy@axsome.com or by phone at 212-332-5061 for more information.

About this study: A Study to Investigate the Effect of Xywav on Sleepiness, Polysomnography, and Functional Outcomes in Participants with Idiopathic Hypersomnia or Narcolepsy. This study is an open label extension that will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy. Contact Clinical Trial Disclosure & Transparency at ClinicalTrialDisclosure@JazzPharma.com or by phone at 215-832-3750 for more information.

About this study: A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy. 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 health care 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. Contact Clinical Trial Disclosure & Transparency at ClinicalTrialDisclosure@JazzPharma.com or by phone at 215-832-3750 for more information.

The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1). This study will look at the safety of TAK-861 along with improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes. This study was initiated in parallel with the parent phase 2 studies, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916), which included participants with NT1 and narcolepsy type 2 (NT2), respectively. This long-term extension (LTE) study enrolled participants with both diagnoses from the two phase 2 studies. As the TAK-861-2002 study did not meet prespecified criteria, all participants with NT2 have been discontinued, and this extension study will only include participants with NT1 who previously completed a parent study. Additional parent studies include all TAK-861 phase 3 studies. The study will enroll up to 500 patients. Participants will be assigned to one of the treatment groups according to the dose assigned to them in their parent study. Similarly, participants who were previously on a placebo dose will also be assigned to one of the treatment groups randomly. All participants in the study will receive TAK-861. Participants with NT1 will receive the following dose from the parent study: TAK-861 Dose 1 TAK-861 Dose 2 This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to approximately 5 years. Participants will make multiple visits to the clinic (with some visits optionally conducted by home health) and will have a follow-up assessment 4 weeks after the last dose of study drug. This is an open label extension that aims to evaluate the safety and tolerability of TAK-861 on participants with type 1 and type 2 narcolepsy from previous parent studies, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916). For more information contact 877-825-3327 or email medinfoUS@takeda.com.