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Cataplexy clinical trials

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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.

NCT ID: NCT04306952 Completed - Narcolepsy Clinical Trials

Awareness and Self-Compassion Enhancing Narcolepsy Treatment

ASCENT
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

The overall goal of this research is to test the effectiveness of a mindfulness-based intervention (MBI) for improving health-related quality of life as a complementary practice to standard care for narcolepsy. This study is a feasibility trial in which 60 adults with narcolepsy will be randomized to receive either a 4-week (brief), 8-week (standard), or 12-week (extended) MBI. Each MBI will be delivered in small groups using a live videoconferencing platform and teaches mindfulness practices to help cope with narcolepsy symptoms. By developing a scalable mind-body intervention, this project can addresses a major research gap on improving psychosocial functioning in people with narcolepsy.

NCT ID: NCT04072380 Completed - Narcolepsy Clinical Trials

A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy

SUVN-G3031
Start date: September 21, 2019
Phase: Phase 2
Study type: Interventional

This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo.

NCT ID: NCT04026958 Recruiting - Clinical trials for Idiopathic Hypersomnia

Clarithromycin Mechanisms in Hypersomnia Syndromes

Start date: September 4, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate a medication called clarithromycin for treating sleepiness in narcolepsy and idiopathic hypersomnia. Studies have shown that clarithromycin can reduce sleepiness, but researchers do not know how clarithromycin does this. This study will look at brain activity (on magnetic resonance imaging [MRI]), inflammation, bacteria living in the gut, and cerebrospinal fluid, to better understand how clarithromycin can reduce sleepiness. This study will recruit 92 participants who will be randomized to receive clarithromycin or a placebo for 14 days.

NCT ID: NCT03881852 Completed - Narcolepsy Clinical Trials

Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)

CONCERT
Start date: January 30, 2019
Phase: Phase 2
Study type: Interventional

CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.

NCT ID: NCT03772314 Completed - Clinical trials for Idiopathic Hypersomnia

Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia

Start date: April 15, 2019
Phase: Phase 2
Study type: Interventional

For diseases that cause excessive daytime sleepiness (such as narcolepsy and idiopathic hypersomnia), there are several medications that can be used to treat sleepiness. However, it can be difficult to decide which medication to use for a particular individual for several reasons: 1) there are very few studies that directly compare two medications to see which works best; 2) there are very few studies that include people with a disorder of sleepiness called idiopathic hypersomnia. To address this gap in knowledge, the researchers propose a randomized clinical trial comparing modafinil and amphetamine salts in patients with narcolepsy type 2 or idiopathic hypersomnia. All participants will either receive modafinil or amphetamine salts - no participant will receive placebo. This study will evaluate which medication works better to improve sleepiness. The researchers will also see which medication is better for other symptoms including difficulty waking up and difficulty thinking, as well as seeing which medication causes fewer side effects. Finally, this study will see if any information about patients (such as age or sleep study features) predicts responding better to one medication or the other.

NCT ID: NCT03433131 No longer available - Clinical trials for Narcolepsy With Cataplexy

Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy

Start date: n/a
Phase:
Study type: Expanded Access

This EAP will be open to provide access to treatment with pitolisant while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval. This program will be open to adult patients in the U.S. with Excessive Daytime Sleepiness (EDS) associated with narcolepsy, with or without cataplexy. Pitolisant will be made available through treating physicians participating in the program.

NCT ID: NCT03425214 Recruiting - Narcolepsy Clinical Trials

Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder

NC-TCSP-IRMf
Start date: January 19, 2018
Phase: N/A
Study type: Interventional

Up to 50% of Narcolepsy-cataplexy (NC) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. A strong link was found between RBD and impulse control disorders (ICD) in Parkinson disease (PD) patients. ICD are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so called ''reward system''. A recent study in IRMf shows that RBD is associated with impaired reward system. A strong link was found between these two disorders and therefore we believe that RBD is associated with impaired reward system in NC The main objective of this study is to evaluate differences in brain activation between NC patients with and without RBD. The investigators hypothesize that NC patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD.

NCT ID: NCT03198156 Terminated - Hypersomnia Clinical Trials

Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy

tDCS
Start date: September 1, 2017
Phase: N/A
Study type: Interventional

1. To determine the effects of transcranial direct current stimulation (tDCS) on vigilance in subjects with central hypersomnia without cataplexy. 2. To determine the effects of tDCS on subjective measures of sleepiness and alertness in subjects with central hypersomnia without cataplexy.

NCT ID: NCT03030599 Completed - Clinical trials for Narcolepsy With Cataplexy

A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

Start date: March 14, 2017
Phase: Phase 3
Study type: Interventional

This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.