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 treatments safety and to understand its effects over time, with participant involvement lasting through the entire study period.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study is an open-label extension designed to continue monitoring participants who completed earlier ALKS 2680 parent studies, focusing on treatment durability and adverse events over an extended period. Participants receive ALKS 2680 oral tablets in doses ranging from 4 mg to 18 mg once daily. The study includes groups with Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia. Treatment effects and safety are observed for up to 100 weeks, with dosing adjusted as needed. The study follows a non-randomized, open-label design without blinding. During the study, participants undergo regular assessments including monitoring of treatment-emergent adverse events, measurement of sleep latency using the Maintenance of Wakefulness Test, and evaluation of daytime sleepiness via the Epworth Sleepiness Scale. The total participation duration extends up to approximately 100 weeks, with safety, tolerability, and treatment effects closely tracked throughout this period.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HBS-301 in adults aged 18 years and older with narcolepsy. The study focuses on treating excessive daytime sleepiness EDS, cataplexy, sleepinesswakefulness, and fatigue in participants diagnosed with narcolepsy. Approximately 258 participants will be included in this trial. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking. The study includes a ScreeningBaseline period lasting up to 28 days, followed by an 8-week Double-blind Treatment period. After this, participants may choose to enter a 1-year Open-label Extension period where they will receive HBS-301. Finally, a 30-day safety follow-up will monitor participants after treatment ends. Throughout the study, participants will undergo various assessments including evaluations of daytime sleepiness using the Epworth Sleepiness Scale, cataplexy frequency, wakefulness through the Maintenance of Wakefulness Test, fatigue levels, cognitive complaints, quality of life, and work productivity. Safety will be monitored by tracking adverse events and pharmacokinetic measurements. The total study participation may last up to approximately 16 months including all phases.

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.

Narcolepsy Type 1 NT1 is a sleep disorder characterized by excessive daytime sleepiness and sudden muscle weakness while conscious, known as cataplexy. This trial evaluates the safety and tolerability of TAK-360 in adults with NT1. Participants must stop their current NT1 medications before starting the study treatment. They may be randomly assigned to receive either TAK-360 or a placebo, which looks identical but contains no active medicine. The trial is sponsored by Takeda and uses a randomized, double-blind design. Participants will take TAK-360 or matching placebo tablets orally. The study includes multiple parts where participants receive either TAK-360 or placebo in a parallel design. After the treatment period lasting up to about 28 weeks, participants will be monitored for an additional two weeks. Following study treatment, participants can resume their usual NT1 medications. Throughout the trial, participants will visit the clinic multiple times for evaluations. Researchers will assess treatment-emergent adverse events, sleep latency using the Maintenance of Wakefulness Test, sleepiness levels with the Epworth Sleepiness Scale, and weekly cataplexy rates. Safety and tolerability will be closely monitored, and participants usual care will continue after the study ends.

Researchers are studying TAK-360 in adults with central hypersomnia conditions, including narcolepsy type 1 NT1, type 2 NT2, and idiopathic hypersomnia IH. These conditions cause excessive daytime sleepiness, with NT1 also involving sudden muscle weakness called cataplexy. The study focuses on evaluating the long-term safety and tolerability of TAK-360 over an extended period in participants who previously took part in parent TAK-360 trials. Participants will receive TAK-360 tablets at the same or closest available dose from their previous parent study, continuing for up to approximately five years. Those who received a placebo in the parent trials will be given an active TAK-360 dose in this long-term extension. Placebo tablets may be used only to maintain dose blinding during the study. The trial involves multiple clinic visits for ongoing monitoring. Throughout the study, participants will undergo various assessments, including tracking treatment-emergent adverse events over up to five years. Researchers will also measure changes in sleepiness scores, maintenance of wakefulness, and severity scales specific to IH and narcolepsy subtypes. Cataplexy episodes will be recorded using participant diaries. Safety evaluations and adherence monitoring will occur regularly to ensure participant well-being during the long-term follow-up.

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.

This research aims to evaluate the effects of ALKS 2680 tablets on adults with Narcolepsy Type 1 NT1. The study focuses on measuring reductions in daytime sleepiness, cataplexy sudden loss of muscle tone, and overall disease symptoms. Participants diagnosed with NT1 according to official guidelines are included to assess the impact of the treatment compared to placebo. Participants will be randomly assigned to one of three groups two different doses of ALKS 2680 or a placebo. Each participant will take oral tablets daily for 12 weeks. The study is designed as a phase 3, randomized, double-blind, placebo-controlled trial to thoroughly evaluate the drugs efficacy and safety during this period. During the study, participants will undergo assessments including the Maintenance of Wakefulness Test to measure sleep latency, along with various scales and inventories to evaluate sleepiness, cataplexy rates, cognitive complaints, fatigue, and narcolepsy severity. Safety will be monitored through reports of adverse events over approximately 14 weeks. The total participation time spans the 12-week treatment period and follow-up for safety monitoring.

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 evaluating the effects of ALKS 2680 tablets on adults aged 18 to 70 with Narcolepsy Type 1 NT1, a condition characterized by excessive daytime sleepiness and sudden muscle weakness called cataplexy. This Phase 3 clinical trial aims to measure how ALKS 2680 compares with placebo tablets in reducing these symptoms and improving overall disease severity. Participants receive either one of two doses of ALKS 2680 or a placebo, taking their assigned tablets daily by mouth for 12 weeks. The study uses a randomized, parallel-group design with triple masking to compare these treatments. During this period, researchers monitor changes in sleepiness, cataplexy frequency, cognitive complaints, fatigue, and overall clinical impressions. Participants will undergo various assessments including the Maintenance of Wakefulness Test, Epworth Sleepiness Scale, cataplexy rate tracking, and multiple patient-reported outcome measures. Safety is monitored throughout the study, with treatment-emergent adverse events recorded up to two weeks after the treatment period. The total participation spans approximately 12 weeks of treatment and evaluation.