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ALKS 2680 for Narcolepsy (Vibrance-1 Trial)

Phase 2
Recruiting
Research Sponsored by Alkermes, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at week 5 and 6
Awards & highlights

Summary

This trial aims to test if ALKS 2680 is safe and effective in reducing sleepiness and cataplexy compared to a placebo.

Who is the study for?
This trial is for individuals with Narcolepsy Type 1, a condition causing excessive daytime sleepiness and sometimes sudden muscle weakness. Participants should be diagnosed with this type of narcolepsy to qualify.Check my eligibility
What is being tested?
The study tests ALKS 2680 against a placebo to see if it better reduces sleepiness and cataplexy in people with Narcolepsy Type 1. It's designed to compare the effects of the drug versus no active treatment.See study design
What are the potential side effects?
Possible side effects of ALKS 2680 are not detailed here but typically could include headache, nausea, dizziness, or insomnia. Placebo generally has no side effects since it contains no active medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at week 5 and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at week 5 and 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6
Secondary outcome measures
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6
Incidence of adverse events
Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 8 mg ALKS 2680Experimental Treatment1 Intervention
Group II: 6 mg ALKS 2680Experimental Treatment1 Intervention
Group III: 4 mg ALKS 2680Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

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Who is running the clinical trial?

Alkermes, Inc.Lead Sponsor
114 Previous Clinical Trials
26,808 Total Patients Enrolled
Study Medical Director, MDStudy DirectorAlkermes, Inc.
~53 spots leftby Jul 2025