80 Participants Needed

ALKS 2680 for Narcolepsy

(Vibrance-2 Trial)

Recruiting at 43 trial locations
DG
Overseen ByDirector, Global Clinical Services
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Alkermes, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications prescribed for managing narcolepsy symptoms for at least 14 days before the study and throughout its duration.

Who Is on the Research Team?

MD

Medical Director, MD

Principal Investigator

Alkermes, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I often feel very sleepy during the day.
Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines
I can stop my narcolepsy medications for at least 14 days for the study.
See 2 more

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALKS 2680 or placebo tablets daily to evaluate safety and decrease in sleepiness

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

What Are the Treatments Tested in This Trial?

Interventions

  • ALKS 2680
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: ALKS 2680, 18 mgExperimental Treatment1 Intervention
Group II: ALKS 2680, 14 mgExperimental Treatment1 Intervention
Group III: ALKS 2680, 10 mgExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alkermes, Inc.

Lead Sponsor

Trials
118
Recruited
27,200+

Richard Pops

Alkermes, Inc.

Chief Executive Officer since 1991

BA in Economics from Stanford University

Dr. Craig Hopkinson

Alkermes, Inc.

Chief Medical Officer since 2017

MD

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