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Cataplexy clinical trials

View clinical trials related to Cataplexy.

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NCT ID: NCT05914194 Not yet recruiting - Narcolepsy Type 1 Clinical Trials

A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1

AMAZE
Start date: January 15, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to see how NLS-2 (mazindol extended-release) works on symptoms of narcolepsy, including cataplexy and excessive daytime sleepiness. Approximately 48 participants will take part in the study across the United States. The study treatment (NLS-2 or placebo) will be administered for 8 weeks. After this treatment period, the participant may have the option to participate in a separate long-term extension study during which all participants will be treated with NLS-2.

NCT ID: NCT05709873 Active, not recruiting - Narcolepsy Clinical Trials

Narcolepsy Nightmare Study

Start date: February 22, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test two behavioral treatments for nightmares in adults with narcolepsy. The main questions it aims to answer are: - Is imagery rehearsal therapy (IRT) effective for narcolepsy-related nightmares? - Does adding targeted dream control (TDC) to IRT make it more effective? Participants will be randomized to one of two treatment groups and will be asked to: - Complete a daily log of sleep symptoms for up to 13 weeks. - Attend 7 sessions of treatment. - Complete questionnaires before and after treatment. - Go to the research lab in Evanston, IL to complete a sleep study during a daytime nap (Chicago area residents only).

NCT ID: NCT05615584 Not yet recruiting - Narcolepsy Clinical Trials

Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence

MRM-OREX
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

In humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (NT1), or narcolepsy with cataplexy, or orexin deficiency syndrome. The International Classification of Sleep Disorders 3rd edition (ICSD-3) distinguishes between hypersomnolence of central origin: NT1, narcolepsy type 2 (NT2), or narcolepsy without cataplexy, and idiopathic hypersomnia (HI). These rare conditions are all characterised by hypersomnolence (excessive daytime sleepiness, or excessive need for sleep), which is the primary and often most disabling symptom. A level of ORX-A in cerebrospinal fluid (CSF) (<110 pg/mL) is a very sensitive and specific biomarker of NT1, currently sufficient for the diagnosis of this condition. In contrast, ORX neurons are thought to be intact in IH and NT2, and the pathophysiological mechanisms underlying these diseases remain unknown. Thus, their diagnosis is based solely on clinical and electrophysiological criteria. The objective of this project is to determine the validity of a mass spectrometric technique for the determination of ORX-A in the cerebral spinal fluid of patients suffering from hypersomnolence in comparison with the radioimmunoassay which is the reference technique.

NCT ID: NCT05113745 Enrolling by invitation - Narcolepsy Clinical Trials

A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy

Start date: October 20, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

NCT ID: NCT05059223 Completed - Narcolepsy Clinical Trials

A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

SYMPHONY
Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

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).

NCT ID: NCT05055024 Completed - Narcolepsy Clinical Trials

An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy

Start date: October 26, 2021
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy.

NCT ID: NCT05015673 Completed - Narcolepsy Clinical Trials

This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.

Start date: June 5, 2014
Phase: Phase 1
Study type: Interventional

This is a study to determine the effect of multiple doses of an investigational drug, taken by mouth, in people with Narcolepsy-cataplexy.

NCT ID: NCT04923594 Completed - Narcolepsy Clinical Trials

Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy

Start date: September 13, 2021
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.

NCT ID: NCT04451668 Completed - Sleep Disturbance Clinical Trials

An Open Label Study of FT218 in Subjects With Narcolepsy

RESTORE
Start date: June 12, 2020
Phase: Phase 3
Study type: Interventional

An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy

NCT ID: NCT04419792 Suspended - Narcolepsy Clinical Trials

'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'

Start date: October 15, 2019
Phase:
Study type: Observational

Narcolepsy is a sleep disorder characterised by excessive daytime sleepiness and significantly impacts quality of life. People with narcolepsy demonstrate many potential barriers to being physically active, such as sleepiness and social isolation. Very little is known about how physical performance variables may be affected and influence disease experience in people with narcolepsy. This study aims to profile the physical fitness and physical functioning variables of adults with narcolepsy and to explore the relationship between physical variables, quality of life, symptom severity and disease experience in this cohort.