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

Phase 2

Active, not recruiting

• Conditions: Narcolepsy Type 1
• Interventions: Drug: ALKS 2680; Drug: Placebo

• Registration Number: NCT06358950
• Lead Sponsor: Alkermes, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-28
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 mg ALKS 2680	ALKS 2680	-
6 mg ALKS 2680	ALKS 2680	-
Placebo	Placebo	-
8 mg ALKS 2680	ALKS 2680	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Alkermes Investigational Site; 🇪🇸 Madrid, Spain

Alkermes Investigator Site; 🇦🇺 Bedford Park, South Australia, Australia