Narcolepsy Type 1
Conditions
Keywords
Brillance, Narcolepsy, Narcolepsy Type 1, Sleep Disorders, Fatigue, Cataplexy, ALKS 2680, Alixorexton, Orexin-2 receptor agonist, excessive daytime sleepiness
Brief summary
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
Interventions
DRUGALKS 2680 Dose 1
Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
DRUGALKS 2680 Dose 2
Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
DRUGPlacebo
Participants will receive ALKS 2680-matching placebo tablets, orally, for 12 weeks.
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\* or CSF hypocretin-1 level).
Exclusion criteria
* Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle. * Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study. * Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment. * Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level | Baseline to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level | Baseline to Week 12 |
| Weekly cataplexy rate (WCR) at Week 12 by dose level | Week 12 |
| Percentage of participants who achieve a status of "none" or "mild" on Patient Global Impression- Severity (PGI-S) scale (general disease) at Week 12 by dose level | Week 12 |
| Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level | Baseline to Week 12 |
| Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level | Baseline to Week 12 |
| Change in Patient-Reported Outcomes Measurement Information System - Fatigue 6a (PROMIS Fatigue 6a) from baseline to Week 12 by dose level | Baseline to Week 12 |
| Percentage of participants who achieve a status of "normal, not ill at all", "borderline ill", or "mildly ill" on Clinical Global Impression-Severity (CGI-S) (general disease) at Week 12 by dose level | Week 12 |
| Change in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) from baseline to Week 12 by dose level | Baseline to Week 12 |
| Incidence of treatment emergent adverse events | Up to 14 weeks |
Countries
Australia, Belgium, Canada, France, Italy, Japan, Netherlands, Spain, United States
Contacts
CONTACTDirector, Clinical Trial Manager
STUDY_DIRECTORMedical Director, MD
Alkermes, Inc.
Outcome results
None listed