ALKS 2680 for Narcolepsy

(Vibrance-2 Trial)

Recruiting at 43 trial locations

Overseen By Director, 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: 8 weeks

80 Participants Needed

Trial Summary

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.

Research Team

Medical Director, MD

Principal Investigator

Alkermes, Inc.

Eligibility Criteria

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.

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 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

Treatment Details

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.

Participant Groups

Group I: ALKS 2680, 18 mg Experimental Treatment 1 Intervention

Oral tablet containing 18mg of ALKS 2680 for once daily administration

Group II: ALKS 2680, 14 mg Experimental Treatment 1 Intervention

Oral tablet containing 14mg of ALKS 2680 for once daily administration

Group III: ALKS 2680, 10 mg Experimental Treatment 1 Intervention

Oral tablet containing 10mg of ALKS 2680 for once daily administration

Group IV: Placebo Placebo Group 1 Intervention

Oral tablet containing matching placebo for once daily administration

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