Clinical trials: Drowsiness
Narcolepsy
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg…
- Trial name
- NCT02821715
- Testing
- THN102 300/3, THN102 300/27
- Where
- 8 sites in Belgium, France
- Volunteers
- 51 people
- Sponsor
- Theranexus
Narcolepsy
Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy
The purpose of this study is to assess the effectiveness and safety of the drug GSK189254 in treating patients with narcolepsy.
- Trial name
- NCT00366080
- Testing
- GSK189254
- Where
- 14 sites in Austria, Finland and 4 more
- Volunteers
- 69 people
- Sponsor
- GlaxoSmithKline
Traumatic Brain Injury
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
- Trial name
- NCT00893789
- Testing
- Armodafinil
- Where
- 73 sites in United States, Germany and 2 more
- Volunteers
- 117 people
- Sponsor
- Cephalon, Inc.
Obstructive Sleep Apnea
Study of TAK-925 in Participants With Obstructive Sleep Apnea (OSA) Who Are Experiencing Excessive Daytime Sleepiness (EDS) Despite Adequate Use of Continuous Positive Airway Pressure (CPAP)
The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adults with obstructive sleep apnea (OSA) who are experiencing excessive daytime…
- Trial name
- NCT04091425
- Testing
- TAK-925
- Where
- 18 sites in United States
- Volunteers
- 25 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Excessive Daytime Sleepiness, Narcolepsy
A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated…
- Trial name
- NCT01006122
- Testing
- PF-03654746
- Where
- 21 sites in United States
- Volunteers
- 95 people
- Sponsor
- Pfizer
Narcolepsy Without Cataplexy, 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
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.
- Trial name
- NCT03433131
- Testing
- Pitolisant
- Where
- 71 sites in United States
- Sponsor
- Harmony Biosciences Management, Inc.
Narcolepsy
A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy
The purpose of the trial is to determine if Lu AH69593 is safe and well tolerated. The trial will also look at how the body processes Lu AH69593 with and without food.
- Trial name
- NCT07613710
- Testing
- Lu AH69593
- Where
- 2 sites in Finland
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Narcolepsy
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.
This is a study to determine the effect of multiple doses of an investigational drug, taken by mouth, in people with Narcolepsy-cataplexy.
- Trial name
- NCT05015673
- Testing
- SEP363856
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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, Excessive Daytime Sleepiness
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.
- Trial name
- NCT02215499
- Testing
- Sodium Oxybate, JZP-386
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Chronic Insomnia, Sleep Deprivation
Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders.
- Conditions
- Chronic Insomnia, Sleep Deprivation, REM Behavior Disorder, REM Sleep Behavior Disorder
- Trial name
- PSHW (NCT06644573)
- Testing
- PROSOMNIA Sleep Therapy™ (PSTx), Anesthesia-Induced Sleep Therapy, Diprivan (propofol), Astra-Zeneca
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Nyree Penn
Obstructive Sleep Apnea, Sleep Hypopnea
Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep…
- Trial name
- NCT00079677
- Testing
- Armodafinil 150 mg/day
- Volunteers
- 263 people
- Sponsor
- Cephalon
Narcolepsy
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy.
- Trial name
- NCT01624480
- Testing
- Armodafinil
- Where
- 24 sites in United States, Finland
- Volunteers
- 40 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Sleep Disorders, Obstructive Sleep Apnea
Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression
The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea…
- Conditions
- Sleep Disorders, Obstructive Sleep Apnea, Major Depressive Disorder, Dysthymic Disorder
- Trial name
- NCT00518986
- Testing
- armodafinil
- Where
- 62 sites in United States
- Volunteers
- 249 people
- Sponsor
- Cephalon
Narcolepsy
A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to Xywav, a low-sodium oxybate.
- Trial name
- XYLO (NCT05869773)
- Testing
- JZP258
- Where
- 43 sites in United States, Belgium and 3 more
- Volunteers
- 155 people
- Sponsor
- Jazz Pharmaceuticals
Excessive Sleepiness
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved…
- Trial name
- NCT01080807
- Testing
- Armodafinil
- Where
- 63 sites in United States
- Volunteers
- 385 people
- Sponsor
- Cephalon
ADHD, Narcolepsy
Pilot Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Abuse Liability of an Abuse-Deterrent Immediate-Release Formulation (ADAIR)
This is a pilot randomized, double-blind, active-controlled, 2-treatment, crossover study to evaluate the PK, user experience and abuse liability of manipulated ADAIR compared to a manipulated commercially-available d-amphetamine…
- Trial name
- NCT04232644
- Testing
- ADAIR 10mg IR capsules, Crushed d-amphetamine sulfate IR tablets
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vallon Pharmaceuticals, Inc.
Excessive Sleepiness
Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance
The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have…
- Trial name
- NCT00711516
- Testing
- Armodafinil
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Cephalon
Myotonic Dystrophy, Type 1 (DM1), Myotonic Dystrophy
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1
Participants in this study will receive two treatments, placebo and ERX-963, on different days in a randomized fashion. The primary purpose of this study is to investigate the safety and tolerability of ERX-963 in participants…
- Trial name
- NCT03959189
- Testing
- ERX-963
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Expansion Therapeutics, Inc.
Healthy Participants
Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg
Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes.
- Trial name
- NCT06348303
- Testing
- Metaxalone m640 mg oral tablet, Metaxalone 800 mg oral tablet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Primus Pharmaceuticals