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A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)

NCT06358950 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-10-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ALKS 2680

Oral tablet of ALKS 2680 for once daily administration

DRUG

Placebo

Oral tablet containing matching placebo for once daily administration

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Medical Director, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2025-06-19
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06358950 on ClinicalTrials.gov