Clinical trials: Narcolepsy
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
Healthy, Narcolepsy
A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)
The goal of this study is to learn what happens to MK-6552 in a person's body over time. Researchers will compare what happens to levels of MK-6552 in people's blood when it is taken with and without modafinil.
- Trial name
- NCT06665230
- Testing
- MK-6552, Modafinil
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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 With or Without Cataplexy
Single-dose Safety Study of APD916 in Healthy Volunteers
The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose
- Trial name
- NCT01093508
- Testing
- APD916
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Arena Pharmaceuticals
Narcolepsy Type 1, Narcolepsy Type 2
A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness [EDS]).
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- CRYSTAL-1 (NCT06752668)
- Testing
- ORX750
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 248 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Narcolepsy
A Study to Collect Information of People With Narcolepsy in Spain
This study aims to review information of people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day including falling asleep suddenly.
- Trial name
- SOMNUS (NCT04667338)
- Where
- Spain
- Volunteers
- 214 people
- Sponsor
- Takeda
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 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, 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, Narcolepsy Type 2
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS…
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT06767683
- Testing
- ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg
- Where
- 50 sites in United States, Australia and 6 more
- Volunteers
- 786 people
- Sponsor
- Alkermes, Inc.
Narcolepsy
Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy
The study is planned to provide expanded access treatment to subjects with narcolepsy who have completed the 2-week treatment phase and follow-up in study CTP2S13031H3 (NCT04072380), and in instances when the investigator as well…
- Trial name
- NCT05530447
- Testing
- Samelisant
- Sponsor
- Suven Life Sciences Limited
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.
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
Narcolepsy
A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy
The rationale for the patient-centric, prospective, observational, non-interventional study design of JZP258-402 is to evaluate the transition experience of participants with narcolepsy treated with oxybate and to examine the…
- Trial name
- NCT04803786
- Testing
- Transition from Xyrem to Xywav
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Jazz Pharmaceuticals
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 Type 2
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.
- Trial name
- Vibrance-2 (NCT06555783)
- Testing
- ALKS 2680
- Where
- 47 sites in United States, Australia and 6 more
- Volunteers
- 93 people
- Sponsor
- Alkermes, 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
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
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
- NCT01485770
- Testing
- ADX-N05
- Where
- 10 sites in United States
- Volunteers
- 33 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy Type 1, Narcolepsy Type 2
A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2)…
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT07096674
- Testing
- ORX750
- Where
- 24 sites in United States, Canada and 2 more
- Volunteers
- 90 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
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