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

April 5, 2024 updated by: Alkermes, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Huntersville, North Carolina, United States, 28708
        • Recruiting
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral tablet containing matching placebo for once daily administration
Experimental: 4 mg ALKS 2680
Drug: ALKS 2680
Oral tablet of ALKS 2680 for once daily administration
Experimental: 6 mg ALKS 2680
Drug: ALKS 2680
Oral tablet of ALKS 2680 for once daily administration
Experimental: 8 mg ALKS 2680
Drug: ALKS 2680
Oral tablet of ALKS 2680 for once daily administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6
Time Frame: Baseline to Week 6
Baseline to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6
Time Frame: 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
Mean weekly cataplexy rate (WCR) as derived by subject cataplexy
Time Frame: Measured at Week 5 and 6
Measured at Week 5 and 6
Incidence of adverse events
Time Frame: Up to 15 Weeks
Up to 15 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Investigators

  • Study Director: Study Medical Director, MD, Alkermes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALKS 2860-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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