Narcolepsy Type 1
Conditions
Keywords
Narcolepsy, Cataplexy, Orexin
Brief summary
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 ("sudden loss of muscle control"), compared to participants taking placebo alone.
Interventions
DRUGALKS 2680
Oral tablet of ALKS 2680 for once daily administration
DRUGPlacebo
Oral tablet containing matching placebo for once daily administration
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18-70 years of age * Has a BMI ≥18 and ≤40 kg/m2 * Meets the diagnostic criteria of Narcolepsy type 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria: * Is HLA-DQB1\*06:02-positive * Has residual excessive daytime sleepiness and cataplexy * Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study * Is willing to adhere to additional protocol requirements
Exclusion criteria
* Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator * Is currently pregnant, breastfeeding, or planning to become pregnant during the study * Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6 | Baseline to Week 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6 | Baseline to Week 6 | Epsworth Sleepiness Scale is a 4-point scale used to measure excessive sleepiness from 0 (would never doze) to 3 (high chance of "dozing) |
| Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary | Measured at Week 5 and 6 | — |
| Incidence of adverse events | Up to 15 Weeks | — |
Countries
Australia, Belgium, Czechia, France, Italy, Netherlands, Spain, United States
Contacts
STUDY_DIRECTORStudy Medical Director, MD
Alkermes, Inc.
Outcome results
None listed