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

Narcolepsy Type 1 Clinical Trial

— Vibrance-1  

Official title:

A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06358950
• Other study ID #: ALKS 2860-201
• Status: Recruiting
• Phase: Phase 2
• Start date: March 28, 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Alkermes, Inc.
• Contact: Global Clinical Services
• Phone: US: 888-235-8008
• Email: clinicaltrials[@]alkermes.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18-70 years of age
• Has a BMI =18 and =35 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

Related Conditions & MeSH terms

• Narcolepsy
• Narcolepsy Type 1

Intervention

Drug:
• ALKS 2680
Oral tablet of ALKS 2680 for once daily administration
• Placebo
Oral tablet containing matching placebo for once daily administration

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Columbia	South Carolina
United States	Alkermes Investigational Site	Huntersville	North Carolina
United States	Alkermes Investigational Site	Macon	Georgia
United States	Alkermes Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6		Baseline to Week 6
Secondary	Change in Epworth Sleepiness Scale (ESS) from 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)	Baseline to Week 6
Secondary	Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary		Measured at Week 5 and 6
Secondary	Incidence of adverse events		Up to 15 Weeks

External Links

•   Vibrance-1 Study