Search > Narcolepsy
176 Participants NeededMy employer runs this trial

ALKS 2680 for Narcolepsy

(Brilliance NT2 Trial)

Recruiting at 7 trial locations
DC
Overseen ByDirector Clinical Trial Manager
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Alkermes, Inc.
Disqualifiers: Comorbid sleep disorder, Significant illness, others
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 decreases in daytime sleepiness, and disease symptoms in participants with Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets compared with placebo tablets.

Who Is on the Research Team?

SD

Study Director, MD

Principal Investigator

Alkermes, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

* Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
* Meets the diagnostic criteria of NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT).

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 to measure decreases in daytime sleepiness and disease symptoms

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ALKS 2680

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: ALKS 2680 Dose 3Experimental Treatment1 Intervention
Group II: ALKS 2680 Dose 2Experimental Treatment1 Intervention
Group III: ALKS 2680 Dose 1Experimental 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

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.