Cataplexy

Researchers are conducting a long-term extension study to evaluate the safety, tolerability, and effectiveness of ORX750 in adults aged 18 to 65 years who have narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. This study follows participants who completed a previous ORX750 clinical trial and focuses on providing ongoing information about the treatment over an extended period. Participants will receive oral ORX750 in an open-label format, grouped by their specific diagnosis: narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. The study does not involve randomization or blinding, allowing all participants to know they are receiving the study drug. The treatment and monitoring periods include assessments up to about 70 days for safety and roughly 63 days for measures of drug concentration and wakefulness. During the study, participants will undergo frequent evaluations including monitoring for adverse events, laboratory tests, vital signs, ECGs, and assessments for suicidal thoughts or behaviors. They will also complete tests measuring wakefulness and sleepiness levels. This ongoing observation aims to ensure the treatment's safety and to understand its effects over time, with participant involvement lasting through the entire study period.

Researchers are studying the safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This open-label, long-term extension study builds on previous ALKS 2680 parent studies and aims to understand how well the treatment works over time and how safe it is for participants living with these sleep disorders. Participants will take oral tablets of ALKS 2680 once daily, with doses ranging from 4 mg to 18 mg. The study is non-randomized and includes groups of people with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. Those joining the study may need to stop other narcolepsy medications before starting ALKS 2680 and continue taking ALKS 2680 throughout the trial. During the study, participants will be monitored for treatment side effects and changes in sleepiness using tests like the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. Researchers will track adverse events for up to 100 weeks and evaluate changes in sleep latency and sleepiness over several months. The study supports close safety monitoring and long-term follow-up from the start in early 2025 until mid-2028.

Researchers are evaluating the safety, tolerability, and effects of ORX750 in adults with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH). These rare conditions cause excessive daytime sleepiness and affect daily activities such as school, work, and driving. The study aims to understand how ORX750, which mimics the brain protein orexin that helps maintain wakefulness, impacts sleepiness and other symptoms in these conditions. Participants will receive either ORX750 capsules or matching placebo capsules in a randomized, double-blind setup. The study assesses multiple groups: those with NT1, NT2, and IH. The treatment and monitoring will occur over a period of up to 35 days, including evaluation of plasma drug levels and sleepiness measures. During the study, participants will undergo safety assessments including monitoring for adverse events, laboratory tests, vital signs, ECGs, and suicidal ideation screening up to day 35. Researchers will also measure sleepiness using the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. The total study duration for each participant is about five weeks, with careful observation of how the body processes ORX750 and its effects on daytime alertness.

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 (NT1). This study focuses on participants who have already been exposed to TAK-861 doses in previous clinical trials. The goal is to monitor how TAK-861 affects symptoms such as excessive daytime sleepiness and cataplexy episodes over a long period. All participants in this trial will receive TAK-861 tablets. Those who previously received a placebo will be randomly assigned to one of the TAK-861 dose groups. The study is a long-term extension conducted worldwide and is expected to last approximately five years or until the product is approved or the study is stopped. Participants may switch doses as needed and will attend multiple clinic visits, some of which can be done at home. Throughout the trial, participants will be regularly assessed for safety by tracking any treatment-emergent adverse events. Researchers will also measure changes in sleep latency, sleepiness scores, and cataplexy rates compared to baseline data from earlier trials. Follow-up assessments will take place four weeks after the final dose to monitor ongoing effects and ensure participant safety.

Researchers are evaluating the effects of ALKS 2680 tablets on adults with Narcolepsy Type 1 (NT1), a condition marked by excessive daytime sleepiness and sudden muscle weakness called cataplexy. This Phase 3 study aims to compare ALKS 2680 with placebo tablets to measure improvements in these symptoms and overall disease severity. Participants will be randomly assigned to one of three groups: a placebo group or one of two different ALKS 2680 dose groups. Each participant will take the assigned oral tablet daily for 12 weeks. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo during the trial. During the study, participants will undergo assessments including the Maintenance of Wakefulness Test to measure sleep latency, the Epworth Sleepiness Scale, cataplexy frequency, cognitive tests, and patient-reported outcomes on fatigue and disease severity. Safety will be monitored throughout, and the primary measurements will focus on changes from baseline to week 12. The total study duration for participants is approximately 12 weeks with follow-up for adverse events up to 14 weeks.

Researchers are evaluating the optimal doses of the drug E2086 compared to placebo in adults with narcolepsy, a condition characterized by excessive daytime sleepiness (EDS). The study focuses on reducing EDS as measured by the Mean Sleep Latency (MSL) using the first four maintenance of wakefulness tests (MWTs). This Phase 2 trial includes participants diagnosed with either narcolepsy type 1 (NT1) or type 2 (NT2) within the last 10 years. Participants will be randomly assigned to receive either E2086 or a matching placebo tablet taken orally once daily for four weeks at low, middle, and high doses. Each dosing period is separated by a washout period of at least seven days, with a total treatment duration of approximately 14 weeks. This design allows comparison of the effects of different doses of E2086 on narcolepsy symptoms. During the study, participants will undergo assessments to measure changes in sleep latency, cataplexy episodes, and sleepiness scales. Additional safety evaluations include monitoring for adverse events, laboratory tests, vital signs, ECG parameters, and suicidality assessments. Blood samples will be collected to analyze drug concentration levels. The study involves regular monitoring up to Day 113 and aims to assess both efficacy and safety over the course of treatment and follow-up.

Researchers are studying the effects of ALKS 2680 tablets on adults with Narcolepsy Type 1 (NT1), a condition characterized by excessive daytime sleepiness and sudden muscle weakness called cataplexy. This Phase 3 trial aims to evaluate changes in these symptoms and overall disease severity compared to placebo tablets. The study is sponsored by Alkermes, Inc. and uses a randomized, double-blind design to measure treatment impact. Participants will be randomly assigned to receive one of two dose levels of ALKS 2680 tablets or placebo tablets. The medication is taken daily by mouth for 12 weeks. The study compares these groups to see how ALKS 2680 influences sleep latency, daytime sleepiness, cataplexy frequency, and other symptoms related to NT1. During the 12-week treatment period, participants will undergo tests such as the Maintenance of Wakefulness Test and complete questionnaires including the Epworth Sleepiness Scale and Patient Global Impression-Severity. Researchers will also monitor cognitive complaints, fatigue, and overall clinical impressions. Safety is assessed through tracking adverse events up to 14 weeks. The total participation duration includes baseline assessments and follow-ups to evaluate treatment effects.

Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2) are rare disorders that cause excessive daytime sleepiness, making it difficult for people to stay alert during daily activities like school, work, or driving. NT1 is often accompanied by cataplexy, a sudden loss of muscle strength triggered by strong emotions, while NT2 does not include this symptom. This research aims to evaluate the safety, tolerability, and effects of cleminorexton, a drug designed to mimic orexin, a brain protein important for wakefulness, in people with NT1 and NT2. Participants will be randomly assigned to one of several groups receiving either one of two doses of oral cleminorexton capsules or a matching placebo. The study includes groups for both NT1 and NT2 participants. The trial will examine how cleminorexton affects symptoms and how the body processes the drug. The study may later include people with idiopathic hypersomnia. This is a double-blind study, meaning neither participants nor researchers know who receives the drug or placebo. During the 12-week study, participants will undergo regular assessments including measuring how long they can stay awake using the Maintenance of Wakefulness Test, and completing sleepiness and narcolepsy severity scales. Researchers will monitor side effects, vital signs, lab tests, ECGs, and suicide risk ratings. They will also measure cleminorexton levels in the blood. Participation will last through the treatment period, with careful safety monitoring throughout.

Researchers are evaluating the drug TAK-861 for treating narcolepsy type 1, also known as narcolepsy with cataplexy. The study aims to understand how well TAK-861 works and whether its effects last over time. It also looks at the safety of TAK-861 and any side effects that might occur when starting or stopping the medication. All participants start by taking TAK-861 during an open-label treatment period. After this, those who meet specific criteria are randomly assigned to either continue TAK-861 at the same dose or switch to a placebo for up to 4 weeks in a double-blind randomized withdrawal period. If participants’ symptoms worsen during this time, they may stop the study treatment and have the option to join a long-term extension study or be followed for 4 weeks after stopping the drug. Participants will be involved for about 31 weeks, undergoing assessments of sleepiness using the Epworth Sleepiness Scale and other tests like the Maintenance of Wakefulness Test and Psychomotor Vigilance Test. Researchers will monitor symptom changes, cataplexy rates, and any adverse events throughout. Safety and efficacy data are collected regularly to understand how TAK-861 affects narcolepsy symptoms over time.

Researchers are evaluating the safety and tolerability of the drug Lu AH69593 in adults who are either healthy or have narcolepsy. The trial also aims to understand how the body processes Lu AH69593 when taken with or without food. This is a Phase 1 randomized, double-blind, placebo-controlled study sponsored by H. Lundbeck A/S, focusing on safety and pharmacokinetics.