Clinical trials: Narcolepsy Without Cataplexy
Narcolepsy Type 1
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
- Trial name
- Brilliance NT1 (NCT07455383)
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 150 people
- Sponsor
- Alkermes, Inc.
Narcolepsy Type 1, Narcolepsy Type 2
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness [EDS]).
- Trial name
- NCT07598708
- Testing
- cleminorexton
- Where
- 23 sites in United States
- Volunteers
- 222 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Narcolepsy
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)
The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment.
- Trial name
- NCT07540364
- Testing
- Samelisant
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Suven Life Sciences Limited
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time.
- Trial name
- NCT07363720
- Testing
- TAK-861
- Where
- 25 sites in United States, France and 5 more
- Volunteers
- 98 people
- Sponsor
- Takeda
EDS, Cataplexy
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy…
- Conditions
- EDS, Cataplexy, Fatigue, Narcolepsy
- Trial name
- NCT07675135
- Testing
- HBS-301
- Where
- 53 sites in United States, Canada
- Volunteers
- 258 people
- Sponsor
- Harmony Biosciences Management, Inc.
Narcolepsy Without Cataplexy, Idiopathic Hypersomnia
Clarithromycin Mechanisms in Hypersomnia Syndromes
The purpose of this study is to evaluate a medication called clarithromycin for treating sleepiness in narcolepsy and idiopathic hypersomnia.
- Conditions
- Narcolepsy Without Cataplexy, Idiopathic Hypersomnia, Narcolepsy With Cataplexy
- Trial name
- NCT04026958
- Testing
- Clarithromycin
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Emory University
Narcolepsy, Narcolepsy Type 1
Decreasing Nightmares in Adults With Narcolepsy
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.
- Conditions
- Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy
- Trial name
- DAWN (NCT06383806)
- Testing
- Imagery Rehearsal Therapy (IRT)
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Utah
Narcolepsy, Idiopathic Hypersomnia
Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence
In humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (NT1), or narcolepsy with cataplexy, or orexin deficiency syndrome.
- Conditions
- Narcolepsy, Idiopathic Hypersomnia, Cataplexy
- Trial name
- MRM-OREX (NCT05615584)
- Testing
- Quantitative mass spectrometry assay
- Where
- France
- Volunteers
- 117 people
- Sponsor
- University Hospital, Montpellier
Narcolepsy, Narcolepsy Type 1
Narcolepsy Nightmare Study
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…
- Conditions
- Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy, Narcolepsy Type 2
- Trial name
- NCT05709873
- Testing
- Imagery rehearsal therapy, Targeted dream control
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Northwestern University
Narcolepsy, Cataplexy Narcolepsy
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
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.
- Conditions
- Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness
- Trial name
- CONCERT (NCT03881852)
- Testing
- AXS-12 (Reboxetine)
- Where
- 14 sites in United States
- Volunteers
- 21 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy Type 1
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy…
- Trial name
- Vibrance-1 (NCT06358950)
- Testing
- ALKS 2680
- Where
- 45 sites in United States, Australia and 6 more
- Volunteers
- 92 people
- Sponsor
- Alkermes, Inc.
Narcolepsy, Cataplexy
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
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).
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Trial name
- SYMPHONY (NCT05059223)
- Testing
- AXS-12 (reboxetine)
- Where
- 50 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy, Cataplexy
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Trial name
- NCT05113745
- Testing
- AXS-12 (reboxetine)
- Where
- 25 sites in United States, Canada
- Volunteers
- 68 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy, Cataplexy
An Open Label Study of FT218 in Subjects With Narcolepsy
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…
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder
- Trial name
- RESTORE (NCT04451668)
- Testing
- FT218
- Where
- 29 sites in United States, Canada
- Volunteers
- 184 people
- Sponsor
- Avadel
Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy
Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period
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.
- Trial name
- NCT02611687
- Testing
- pitolisant
- Where
- 11 sites in Finland, France and 3 more
- Volunteers
- 110 people
- Sponsor
- Bioprojet
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- 2 sites in United States, Australia
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Narcolepsy
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy.
- Trial name
- SUVN-G3031 (NCT04072380)
- Testing
- SUVN-G3031
- Where
- 41 sites in United States, Canada
- Volunteers
- 190 people
- Sponsor
- Suven Life Sciences Limited
Narcolepsy, Narcolepsy Without Cataplexy
Awareness and Self-Compassion Enhancing Narcolepsy Treatment
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.
- Conditions
- Narcolepsy, Narcolepsy Without Cataplexy, Narcolepsy With Cataplexy
- Trial name
- ASCENT (NCT04306952)
- Testing
- Brief MBI, Standard MBI, Extended MBI
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Northwestern University
Idiopathic Hypersomnia, Narcolepsy Without Cataplexy
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
For diseases that cause excessive daytime sleepiness (such as narcolepsy and idiopathic hypersomnia), there are several medications that can be used to treat sleepiness.
- Trial name
- NCT03772314
- Testing
- Modafinil, Amphetamine-Dextroamphetamine
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Emory University
Narcolepsy Type 1, Narcolepsy With Cataplexy
A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1
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.
- Trial name
- AMAZE (NCT05914194)
- Testing
- NLS-2
- Volunteers
- 48 people
- Sponsor
- NLS Pharmaceutics