CompletedPhase 2

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)

United States92 participantsStarted 2024-03-28

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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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 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

What they're measuring

Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6

Timeframe: Baseline to Week 6

Trial details

NCT IDNCT06358950

SponsorAlkermes, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-19