ALKS 2680 for Narcolepsy

Overseen By Director, Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alkermes, Inc.

Disqualifiers: Comorbid sleep disorder, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well ALKS 2680 tablets can reduce daytime sleepiness and sudden muscle weakness (cataplexy) in people with narcolepsy type 1 (NT1). Participants will receive either one of two doses of ALKS 2680 or a placebo (a pill with no active medicine) to compare the treatment's effectiveness. Individuals diagnosed with NT1 who often experience unexpected sleep episodes or muscle weakness during the day may find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment for NT1.

Do I have to stop taking my current medications for the trial?

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.

Is there any evidence suggesting that ALKS 2680 is likely to be safe for humans?

Previous studies have shown that ALKS 2680 is generally well-tolerated by patients. Research indicates that a single dose of up to 8 mg can significantly improve sleep without causing serious side effects. Patients manage the treatment easily with a simple once-a-day pill. No major negative effects have been reported, making the treatment's safety promising for those considering participation in clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for narcolepsy?

Unlike the standard treatments for narcolepsy, which often include stimulants like modafinil and sodium oxybate, ALKS 2680 is unique because it introduces a novel mechanism of action. Researchers are excited about ALKS 2680 because it targets specific receptors in the brain that are directly involved in sleep-wake regulation, potentially offering improved alertness with fewer side effects. This targeted approach could provide a more effective solution for managing narcolepsy symptoms, which is why there's a buzz around its potential benefits.

What evidence suggests that ALKS 2680 might be an effective treatment for narcolepsy?

Research has shown that ALKS 2680 holds promise for treating narcolepsy symptoms. This trial will evaluate different doses of ALKS 2680. Studies have found that ALKS 2680 helps people with narcolepsy type 1 stay awake and feel less sleepy during the day. In one study, patients noticed improved wakefulness during the day. Most patients tolerated the treatment well, experiencing no serious side effects. This evidence suggests ALKS 2680 could help manage daytime sleepiness and other narcolepsy symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Medical Director, MD

Principal Investigator

Alkermes, Inc.

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with narcolepsy type 1 (NT1), confirmed by sleep studies or specific lab tests. Participants must have significant daytime sleepiness and meet standard medical criteria for NT1.

Inclusion Criteria

Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT or CSF hypocretin-1 level)

Exclusion Criteria

Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study

Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment

Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

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, cataplexy, 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

Trial Overview

The study compares two different doses of a new tablet called ALKS 2680 to a placebo (inactive pill) in people with NT1, to see if it reduces daytime sleepiness and cataplexy symptoms. Participants are randomly assigned to one of the groups.

How Is the Trial Designed?

Group I: ALKS 2680 Dose 2 Experimental Treatment 1 Intervention

Group II: ALKS 2680 Dose 1 Experimental Treatment 1 Intervention

Group III: 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

Citations

1.

investor.alkermes.com

investor.alkermes.com/news-releases/news-release-details/alkermes-presents-data-phase-1b-study-alks-2680-demonstrating/

Alkermes Presents Data From Phase 1b Study of ALKS 2680 ...

Alkermes Presents Data From Phase 1b Study of ALKS 2680 Demonstrating Improved Wakefulness in Patients With Narcolepsy Type 1 at SLEEP 2024.

2.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000210498

The Orexin 2 Receptor Agonist ALKS 2680 in Patients with ...

ALKS 2680 was generally well-tolerated. Single doses up to 8 mg led to statistically significant, clinically meaningful improvements in sleep ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07540897

NCT07540897 | A Study to Evaluate the Efficacy, Safety ...

A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304). ClinicalTrials.

4.

psychiatrictimes.com

psychiatrictimes.com/view/alixorexton-for-treatment-of-narcolepsy-type-2-new-positive-phase-2-data

Alixorexton for Treatment of Narcolepsy Type 2

Alixorexton shows promising results in improving wakefulness and reducing daytime sleepiness in patients with narcolepsy type 2.

5.

investor.alkermes.com

investor.alkermes.com/static-files/ca4b6db9-a4ff-4665-96e7-4210ee574990

World Sleep 2025: Alixorexton (ALKS 2680) Narcolepsy Type ...

The results demonstrated alixorexton's significant effect on wakefulness and other important measures and a generally well tolerated profile.

6.

mayo.edu

mayo.edu/research/clinical-trials/cls-20598408

A Study To Evaluate The Safety And Effectiveness Of ALKS ...

The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10591782/

O013 Preliminary Results from a Phase 1 Study of ALKS 2680 ...

Preliminary results suggest that the OX2R agonist ALKS 2680 is generally well-tolerated with a pharmacokinetic profile potentially suitable for once-daily oral ...