Clinical trials: Drowsiness
Narcolepsy
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy
The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.
- Trial name
- NCT03267303
- Testing
- TS-091 5mg, TS-091 10mg
- Where
- 2 sites in Japan, South Korea
- Volunteers
- 53 people
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Narcolepsy, Obstructive Sleep Apnea
SUNOSI® (Solriamfetol) Pregnancy Registry
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep…
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
- Trial name
- NCT06413420
- Testing
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
- Where
- 2 sites in United States
- Volunteers
- 1,731 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy, Obstructive Sleep Apnea
The Nuvigil and Provigil Pregnancy Registry
The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Shift Work Sleep Disorder
- Trial name
- NCT01792583
- Testing
- Modafinil/armodafinil
- Where
- United States
- Volunteers
- 191 people, healthy volunteers welcome
- Sponsor
- Cephalon, Inc.
Prader-Willi Syndrome
A Study of Pitolisant in Patients With Prader-Willi Syndrome
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.
- Trial name
- NCT06366464
- Testing
- Pitolisant tablet
- Where
- 57 sites in United States, Australia and 11 more
- Volunteers
- 134 people
- Sponsor
- Harmony Biosciences Management, Inc.
Parkinson's Disease
Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's Disease
The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances in Parkinson's Disease patients, after 2 months of treatment.
- Trial name
- PD (NCT01032486)
- Testing
- Rasagiline mesylate
- Volunteers
- 120 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Narcolepsy, Sleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep…
- Trial name
- NCT00107848
- Testing
- Modafinil
- Where
- 61 sites in United States, Canada
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Cephalon
Narcolepsy
Child and Adolescent Registry for Participants With Narcolepsy
CATNAP is a patient registry designed to improve the understanding of the natural history of narcolepsy in pediatric patients. Descriptive statistics on disease characteristics will be performed.
- Trial name
- NCT04899947
- Where
- 25 sites in United States
- Volunteers
- 500 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription
Patients will be followed up for max 18 months. Information on the Adverse Events and potential misuse or abuse of Xyrem ® will be collected.
- Trial name
- NCT00244465
- Where
- 41 sites in Austria, Belgium and 7 more
- Volunteers
- 750 people
- Sponsor
- UCB Pharma
Narcolepsy
Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or obstructive sleep apnea/hypopnea…
- Trial name
- NCT00214968
- Testing
- Modafinil
- Volunteers
- 92 people
- Sponsor
- Cephalon
Narcolepsy
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.
- Trial name
- NCT00132873
- Testing
- Xyrem (sodium oxybate) oral solution
- Where
- Canada
- Volunteers
- 59 people
- Sponsor
- Jazz Pharmaceuticals
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
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.
Narcolepsy
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with…
- Trial name
- NCT00107796
- Testing
- Modafinil
- Where
- 73 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
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.
Sleep Apnea, Obstructive
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with obstructive sleep…
- Trial name
- NCT00107809
- Testing
- Modafinil
- Where
- 64 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
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
Pregnancy Related, Narcolepsy
WAKIX® (Pitolisant) Pregnancy Registry
The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant…
- Trial name
- NCT05536011
- Testing
- Pitolisant, Comparator Products
- Where
- United States
- Volunteers
- 1,329 people
- Sponsor
- Harmony Biosciences Management, Inc.
Narcolepsy
Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of study drug or placebo over a 10-11 week…
- Trial name
- NCT00049803
- Testing
- sodium oxybate
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 200 people
- Sponsor
- Orphan Medical
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
The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.
- Trial name
- NCT02221869
- Testing
- Xyrem
- Where
- 20 sites in United States, France and 2 more
- Volunteers
- 106 people
- Sponsor
- Jazz Pharmaceuticals
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