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ALKS 2680 for Narcolepsy (Vibrance-2 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
Has residual excessive daytime sleepiness
18-70 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8

Summary

This trial aims to test whether ALKS 2680 tablets can make people with narcolepsy type 2 feel less sleepy and safe compared to taking placebo tablets.

Who is the study for?
This trial is for individuals with narcolepsy type 2. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to the study's procedures.
What is being tested?
The trial is testing ALKS 2680 tablets against placebo tablets to see if they're safe and can reduce sleepiness in people with narcolepsy type 2.
What are the potential side effects?
While specific side effects of ALKS 2680 aren't listed, common side effects may include headache, nausea, dizziness, or insomnia. Placebo tablets usually have no active ingredients but can cause similar symptoms due to psychological factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I often feel very sleepy during the day.
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I am between 18 and 70 years old.
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My BMI is between 18 and 35.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Epworth Sleepiness Scale (ESS)

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ALKS 2680, 18 mgExperimental Treatment1 Intervention
Oral tablet containing 18mg of ALKS 2680 for once daily administration
Group II: ALKS 2680, 14 mgExperimental Treatment1 Intervention
Oral tablet containing 14mg of ALKS 2680 for once daily administration
Group III: ALKS 2680, 10 mgExperimental Treatment1 Intervention
Oral tablet containing 10mg of ALKS 2680 for once daily administration
Group IV: PlaceboPlacebo Group1 Intervention
Oral tablet containing matching placebo for once daily administration

Find a Location

Who is running the clinical trial?

Alkermes, Inc.Lead Sponsor
115 Previous Clinical Trials
26,899 Total Patients Enrolled
1 Trials studying Narcolepsy
80 Patients Enrolled for Narcolepsy
Medical Director, MDStudy DirectorAlkermes, Inc.
81 Previous Clinical Trials
16,424 Total Patients Enrolled
~47 spots leftby Aug 2025
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