ALKS 2680 for Idiopathic Hypersomnia

(Vibrance-3 Trial)

Recruiting at 7 trial locations

Overseen By Director, Global Clinical Services

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alkermes, Inc.

Disqualifiers: Comorbid sleep disorder, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

96 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research Team

Medical Director

Principal Investigator

Alkermes, Inc.

Eligibility Criteria

This trial is for individuals who meet the diagnostic criteria for Idiopathic Hypersomnia according to specific guidelines, confirmed by evaluations within the last 10 years. Participants must be able to follow the study's requirements, including lifestyle restrictions and using contraception if applicable.

Inclusion Criteria

I am willing and able to follow the study's rules, including lifestyle changes and treatment plans.

I have been diagnosed with Idiopathic Hypersomnia in the last 10 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

6-8 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 tablets against placebo tablets to see if they are safe and can reduce daytime sleepiness in people with Idiopathic Hypersomnia. The effectiveness of ALKS 2680 will be measured and compared with the non-active placebo.

Participant Groups

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

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

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

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

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

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

Group IV: Placebo Placebo Group 1 Intervention

Oral placebo tablet 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