Narcolepsy Study
Comparison Table
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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.-Array | 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. -Array | 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.-Array | 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.- | About this study: A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients with Narcolepsy. This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS). Contact the Study Director at: SYMPHONYstudy@axsome.com or by phone at 212-332-5061 for more information. -Array | 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. -Array | About this study: Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH. This is a study of the safety, efficacy and pharmacokinetics (PK) of Serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH). Contact Medical Affairs at medicalaffairs@zevra.com or by phone at 1-888-289-5607 to find out more about this study. -Array | 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. -Array | 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.-Array | About this study: A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions. The 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). Contact Takeda Contact at medinfoUS@takeda.com or by phone at +1-877-825-3327 for more information. -Array | About this study: The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).- | |
| NCT # | NCT06358950 | NCT05837091 | NCT06179407 | NCT02611687 | NCT05059223 | NCT05113745 | NCT05668754 | NCT05875974 | NCT05869773 | NCT05816382 | NCT05687916 | |
 | What is the main factor the study is measuring? | Excessive Daytime Sleepiness | Total Sleep Time | Adverse Events | Excessive Daytime Sleepiness | Number of Cataplexy Events | Number of Cataplexy Events | Adverse Events (multiple safety measures) | Epworth Sleepiness Scale | Blood Pressure | Adverse Events | Maintenance of Wakefulness Test |
 | Diagnosis | NT1 | IH | NT1 | NT1, NT2 | NT1 | NT1 | IH | NT1, NT2, IH | NT1, NT2 | NT1, NT2 | NT2 |
 | Study Phase | Phase II | Phase IV | Phase I | Phase III | Phase III | Phase III | Phase II | Phase IV | Phase IV | Phase II and III | Phase II |
 | Important criteria to be able to participate | Narcolepsy Diagnosis, BMI 18-35, HLA positive | Total Sleep Time (9 or more hours) | PSG/MSLT verified diagnosis, HLA positive | Narcolepsy diagnosis | PSG/MSLT verified diagnosis | Completed AXS-12-301 study | BMI < 35, Epworth Sleepiness Scale >11, nightly TST >7hrs | PSG/MSLT verified diagnosis, Epworth Sleepiness Scale > 10 | Actively taking Xyrem 6-9g/nt | Completed previous TAK-861 study | PSG/MSLT verified diagnosis |
 | Mechanism | Orexin | GABA / GHB | UNK | Histamine (H3) | Norepinephrine | Norepinephrine | Dexmethyl-phenidate | GABA / GHB | GABA / GHB | Orexin | Orexin |
 | Age Range | 18 to 70 | 18 to 65 | 18 to 55 | 6 to 18 | 15-75 | 15-75 | 18+ | 18-75 | 18-70 | US: 18-70; Japan: 16-70 | 16-70 (US 18-70) |
 | Daytime Testing Required |  | | |  | | | | | | | |
 | Overnight Stays Required | | | | | | | | | | | |
 | Max Study Duration | 15 weeks | 3 months | 5 weeks | 8 weeks | 5 weeks | 28 weeks | 12 weeks | 21 weeks | 6 weeks | 108 weeks | 18 weeks |
 | Is there a possibility of receiving placebo? | | | | | | YES (open-label follows double-blind) | | | | | |
 | Trade Name | Not Published | Xywav | Not Published | Wakix | Edronax (in Europe) | Edronax (in Europe) | Azstarys (for ADHD) | Xywav | Xywav | Not Published | Not Published |
 | Drug Formulation | Tablet | Liquid | Capsule | Tablet | Tablet | Tablet | Capsule | Liquid | Liquid | Tablet | Tablet |
 | Will I be compensated financially for my participation? | | | | | | | | | | | |
 | Can I have other sleep disorders during the trial? | | | | | | | | | | | |
 | Where is the trial being conducting (Region / # of sites) | US (1) | US (4) | US (1) | EU (11) | US (43) Canada (3) | US (26) Canada (1) | US (38) | UNK | US (22) EU (10) | US (25) EU (32) Asia (11) | US (21) EU (20) Asia (10) |
 | Is this an open label study? | | | | | | | | | | | |
Information & research
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