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Narcolepsy Without Cataplexy clinical trials

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NCT ID: NCT06383806 Not yet recruiting - Narcolepsy Clinical Trials

Decreasing Nightmares in Adults With Narcolepsy

DAWN
Start date: July 2024
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment.

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: 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: 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: 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: 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. 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: NCT02611687 Active, not recruiting - Clinical trials for Narcolepsy With Cataplexy

Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period

Start date: June 6, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this multicenter double blind study is to assess efficacy and safety of Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.

NCT ID: NCT02512588 Completed - Clinical trials for Idiopathic Hypersomnia

A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2

Start date: September 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without cataplexy (Type 2).