ALKS 2680 for Narcolepsy

(Vibrance-1 Trial)

Recruiting at 43 trial locations

Overseen By Global Clinical Services

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alkermes, Inc.

Disqualifiers: Other sleep, Cardiovascular, Psychiatric, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

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.

Research Team

Study Medical Director, MD

Principal Investigator

Alkermes, Inc.

Eligibility Criteria

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.

Inclusion Criteria

Meets the diagnostic criteria of Narcolepsy type 1 according to ICSD-3-TR guidelines

Has a BMI ≥18 and ≤35 kg/m2

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALKS 2680 or placebo to assess safety and efficacy, focusing on sleepiness and cataplexy reduction

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ALKS 2680

Trial Overview 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.

Participant Groups

Group I: 8 mg ALKS 2680 Experimental Treatment 1 Intervention

Group II: 6 mg ALKS 2680 Experimental Treatment 1 Intervention

Group III: 4 mg ALKS 2680 Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

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