Clinical trials: Narcolepsy
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 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
Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy.
- Trial name
- NCT00066170
- Testing
- Xyrem, Modafinil at established dose
- Where
- 40 sites in United States, France and 2 more
- Volunteers
- 231 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy, Obstructive Sleep Apnea
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.
- Trial name
- NCT02348632
- Testing
- JZP-110
- Where
- 80 sites in United States, Canada and 4 more
- Volunteers
- 645 people
- Sponsor
- Jazz Pharmaceuticals
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
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.
- Trial name
- NCT01681121
- Testing
- ADX-N05
- Where
- 28 sites in United States
- Volunteers
- 93 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy
The purpose of this study is to evaluate the safety and effectiveness of JNJ-17216498 compared to modafinil and placebo in patients with narcolepsy, with and without cataplexy.
- Trial name
- NCT00424931
- Testing
- JNJ-17216498, Modafinil
- Where
- 16 sites in United States
- Volunteers
- 16 people
- Sponsor
- Alza Corporation, DE, USA
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 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
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 1
A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness [EDS]), where a person may fall asleep without warning.
- Trial name
- NCT07633301
- Testing
- TAK-360
- Where
- 18 sites in United States, Australia and 5 more
- Volunteers
- 92 people
- Sponsor
- Takeda
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
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
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
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 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
Idiopathic Hypersomnia, Narcolepsy
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.
- Trial name
- NCT05875974
- Testing
- JZP258 (XYWAV)
- Where
- 32 sites in United States, Canada
- Volunteers
- 199 people
- Sponsor
- Jazz Pharmaceuticals
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 Type 1 (NT1), Narcolepsy Type 2 (NT2)
A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy
The main aims of the study are: To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate. To check what dose range provides adequate relief of narcolepsy symptoms.
- Trial name
- NCT04096560
- Testing
- TAK-994
- Where
- 78 sites in United States, Canada and 10 more
- Volunteers
- 97 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