A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 (NCT06555783) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
United States93 participantsStarted 2024-07-26
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-70 years of age
* Has a BMI ≥18 and ≤40 kg/m2
* Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.
Additionally, meets the following criteria:
* Has residual excessive daytime sleepiness
* 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
What they're measuring
1
Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)