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

Completed · Phase 2 · Has a placebo group

Conditions studied: Narcolepsy Type 1

In brief

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.

Key facts

Study ID

NCT06358950

Run by

Alkermes, Inc.

People needed

92

Starts

2024-03-24

Expected to finish

2025-07-31

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Los Angeles, California, United States
• Alkermes Investigational Site — Redwood City, California, United States
• Alkermes Investigator Site — San Francisco, California, United States
• Alkermes Investigational Site — Santa Ana, California, United States
• Alkermes Investigational Site — Aurora, Colorado, United States
• Alkermes Investigational Site — Colorado Springs, Colorado, United States
• Alkermes Investigational Site — Brandon, Florida, United States
• Alkermes Investigator Site — Brandon, Florida, United States
• Alkermes Investigational Site — Miami, Florida, United States
• Alkermes Investigator Site — Winter Park, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Macon, Georgia, United States
• Alkermes Investigational Site — Stockbridge, Georgia, United States
• Alkermes Investigator Site — Peoria, Illinois, United States
• Alkermes Investigator Site — Lansing, Michigan, United States
• Alkermes Investigator Site — Sterling Heights, Michigan, United States
• Alkermes Investigator Site — Lincoln, Nebraska, United States
• Alkermes Investigational Site — Middletown, New Jersey, United States
• Alkermes Investigational Site — Denver, North Carolina, United States
• Alkermes Investigational Site — Huntersville, North Carolina, United States
• Alkermes Investigator Site — Canton, Ohio, United States
• Alkermes Investigational Site — Cincinnati, Ohio, United States
• Alkermes Investigational Site — Cincinnati, Ohio, United States
• Alkermes Investigational Site — Dublin, Ohio, United States
• Alkermes Investigational Site — Wyomissing, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.