Clinical trials: Narcolepsy With Cataplexy
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
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.
Intracerebral Hemorrhage
Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
This study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. The primary objective was to assess the safety and tolerability of NXY-059 compared to placebo.
- Trial name
- NCT00075959
- Testing
- NXY-059
- Where
- 64 sites in United States
- Volunteers
- 600 people
- Sponsor
- AstraZeneca
Narcolepsy, Excessive Daytime Sleepiness
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2…
- Conditions
- Narcolepsy, Excessive Daytime Sleepiness, Cataplexy Narcolepsy
- Trial name
- NCT04923594
- Testing
- mazindol extended release
- Where
- 22 sites in United States
- Volunteers
- 67 people
- Sponsor
- NLS Pharmaceutics
Narcolepsy With Cataplexy
A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.
- Trial name
- NCT03030599
- Testing
- JZP-258
- Where
- 25 sites in United States, Belgium and 4 more
- Volunteers
- 201 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with narcolepsy by measuring mean sleep…
- Trial name
- NCT00078377
- Testing
- Armodafinil
- Volunteers
- 196 people
- Sponsor
- Cephalon
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, Sleep Apnea, Obstructive
Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness…
- Conditions
- Narcolepsy, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Shift-Work Sleep Disorder
- Trial name
- NCT00078312
- Testing
- CEP-10953 (Armodafinil)
- Where
- 50 sites in United States, Russia
- Volunteers
- 328 people
- Sponsor
- Cephalon
Narcolepsy Type 2
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night.
- Trial name
- NCT06952699
- Testing
- TAK-360
- Where
- 52 sites in United States, China and 5 more
- Volunteers
- 88 people
- Sponsor
- Takeda
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 Type 1
A Study of TAK-861 in People With Narcolepsy Type 1
The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment.
- Trial name
- NCT06505031
- Testing
- TAK-861
- Where
- 28 sites in Australia, Austria and 9 more
- Volunteers
- 105 people
- Sponsor
- Takeda
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
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 Type 1 (NT 1)
A Study of TAK-994 in Adults With Narcolepsy
Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study. The main aim of this study is to check if participants have side effects from TAK-994.
- Trial name
- NCT04820842
- Testing
- TAK-994
- Where
- 70 sites in United States, Canada and 8 more
- Volunteers
- 26 people
- Sponsor
- Takeda
Narcolepsy Type 1
A Study of TAK-861 for the Treatment of Narcolepsy Type 1
The main aim of this study is to learn how effective TAK-861 (oveporexton) is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment.
- Trial name
- NCT06470828
- Testing
- Oveporexton
- Where
- 53 sites in United States, Canada and 9 more
- Volunteers
- 168 people
- Sponsor
- Takeda
Narcolepsy Type 1
A Study of TAK-861 in Participants With Narcolepsy Type 1
The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy.
- Trial name
- NCT05687903
- Testing
- TAK-861
- Where
- 57 sites in United States, Australia and 10 more
- Volunteers
- 112 people
- Sponsor
- Takeda
Excessive Daytime Sleepiness, Cataplexy
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
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.
- Conditions
- Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
- Trial name
- NCT02720744
- Testing
- FT218
- Where
- 57 sites in United States, Australia and 4 more
- Volunteers
- 212 people
- Sponsor
- Avadel
Idiopathic Hypersomnia, Narcolepsy Without Cataplexy
A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
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).
- Trial name
- NCT02512588
- Testing
- BTD-001
- Where
- 23 sites in United States
- Volunteers
- 120 people
- Sponsor
- Balance Therapeutics
Narcolepsy Type 2
A Study of TAK-861 in Participants With Narcolepsy Type 2
The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).
- Trial name
- NCT05687916
- Testing
- TAK-861 2 mg, TAK-861 2 mg and 5 mg
- Where
- 56 sites in United States, Australia and 10 more
- Volunteers
- 71 people
- Sponsor
- Takeda
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