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Cataplexy clinical trials

View clinical trials related to Cataplexy.

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NCT ID: NCT02913651 Completed - Narcolepsy Clinical Trials

Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

Start date: January 2016
Phase: N/A
Study type: Observational

Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy affecting the sympathetic function. In this study the investigators analyzed whether altered diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free patients diagnosed with idiopathic hypersomnia and age-matched controls were included. Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to spontaneous arousal are analyzed.

NCT ID: NCT02720744 Completed - Narcolepsy Clinical Trials

Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

Start date: November 17, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

NCT ID: NCT02637076 Completed - Healthy Controls Clinical Trials

Xyrem and Brain Dopamine in Narcolepsy

Start date: January 2016
Phase: Phase 4
Study type: Interventional

The overall aim of this investigation is to establish whether an action of Xyrem® on the brain dopamine system in patients with narcolepsy, and in a comparison control group, might explain part of the anti-narcoleptic effect of the drug. Trial Objective is to establish, using positron emission tomography (PET), in Xyrem®-naïve narcolepsy with cataplexy patients, and in matched controls, whether a single dose of Xyrem® causes changes in striatal binding of 11C-raclopride and 11C-DTBZ that would suggest altered activity of brain dopamine neurones.

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).

NCT ID: NCT02221869 Completed - Clinical trials for Narcolepsy With Cataplexy

A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy

Start date: October 1, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.

NCT ID: NCT01800045 Completed - Clinical trials for Excessive Daytime Sleepiness

Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)

Start date: April 2013
Phase: Phase 3
Study type: Interventional

Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week). The patients will be treated during 7 weeks with Pitolisant or placebo.

NCT ID: NCT01793168 Recruiting - Clinical trials for Retinitis Pigmentosa

Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford

CoRDS
Start date: July 2010
Phase:
Study type: Observational [Patient Registry]

CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups, individuals and researchers to help in the advancement of research in over 7,000 rare diseases. The registry is free for patients to enroll and researchers to access. Visit sanfordresearch.org/CoRDS to enroll.

NCT ID: NCT01399606 Completed - Narcolepsy Clinical Trials

Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)

HARMONYIII
Start date: May 2011
Phase: Phase 3
Study type: Interventional

This is a multicentric International Phase III,Long term open label study(12 months)assessing the long-term safety and efficacy of BF2.649 (Pitolisant)in the treatment of Excessive Daytime Sleepiness (EDS) in narcoleptic patients with or without cataplexy.

NCT ID: NCT01183312 Completed - Clinical trials for Idiopathic Hypersomnia

Flumazenil for the Treatment of Primary Hypersomnia

Start date: September 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is caused by a problem with the quality of sleep occurring at night, for instance when nighttime sleep is disrupted by frequent breathing pauses. In other cases, however, hypersomnia occurs even when nighttime sleep is of good quality. These cases of hypersomnia are presumed to be a symptom of brain dysfunction, and so are referred to as hypersomnias of central (i.e., brain) origin, or primary hypersomnias. The causes of most of these primary hypersomnias are not known. However, our group has recently identified a problem with the major brain chemical responsible for sedation, known as GABA. In a subset of our hypersomnia patients, there is a naturally-occurring substance that causes the GABA receptor to be hyperactive. In essence, it is as though these patients are chronically medicated with Valium (or Xanax or alcohol, all substances that act through the GABA system), even though they do not take these medications. Current treatment of central hypersomnias is limited. For the fraction of cases with narcolepsy, there are FDA-approved, available treatments. However, for the remainder of patients, there are no treatments approved by the FDA. They are usually treated with medications approved for narcolepsy, but sleep experts agree that these medications are often not effective for this group of patients. Based on our understanding of the GABA abnormality in these patients, we evaluated whether flumazenil (an medication approved by the FDA for the treatment of overdose of GABA medications or the reversal of GABA-based anesthesia) would reverse the GABA abnormality in our patients. In a test tube model of this disease, flumazenil does in fact return the function of the GABA system to normal. The investigators have treated a few patients with flumazenil and most have felt that their hypersomnia symptoms improved with this treatment. To determine whether flumazenil is truly beneficial for primary hypersomnia, this study will compare flumazenil to an inactive pill (the placebo). All subjects will receive both flumazenil and the placebo at different times, and their reaction times and symptoms will be compared on these two treatments to determine if one is superior. Currently, flumazenil can only be given through an injection into a vein (i.e., intravenously). This study will evaluate this intravenous dosing as well as a new form of flumazenil, which is taken as a lozenge to be dissolved under the tongue. If this study shows that flumazenil is more effective than placebo in the treatment of hypersomnia, it will identify a potential new therapy for this difficult-to-treat disorder.