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

NCT06358950 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ALKS 2860-201
• Study Type: interventional
• Target: 92
• Locations: 8 countries
• Sites: 45

Brief 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

Narcolepsy Type 1

Keywords

Narcolepsy; Cataplexy; Orexin

Outcome Measures

Primary Outcomes (1)

• Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6

  Baseline to Week 6

Secondary Outcomes (3)

• Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6

  Baseline to Week 6

• Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary

  Measured at Week 5 and 6

• Incidence of adverse events

  Up to 15 Weeks

Study Arms (4)

4 mg ALKS 2680

EXPERIMENTAL

Drug: ALKS 2680

6 mg ALKS 2680

EXPERIMENTAL

Drug: ALKS 2680

8 mg ALKS 2680

EXPERIMENTAL

Drug: ALKS 2680

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALKS 2680 DRUG

Oral tablet of ALKS 2680 for once daily administration

4 mg ALKS 2680; 6 mg ALKS 2680; 8 mg ALKS 2680

Placebo DRUG

Oral tablet containing matching placebo for once daily administration

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Has a BMI ≥18 and ≤40 kg/m2
• Meets the diagnostic criteria of Narcolepsy type 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria:
• Is HLA-DQB1\*06:02-positive
• Has residual excessive daytime sleepiness and cataplexy
• Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
• Is willing to adhere to additional protocol requirements

You may not qualify if:

• Is currently pregnant, breastfeeding, or planning to become pregnant during the study
• Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (45)

Alkermes Investigational Site

Los Angeles, California, 90025, United States

Location

Alkermes Investigational Site

Redwood City, California, 94063, United States

Location

Alkermes Investigator Site

San Francisco, California, 94107, United States

Location

Alkermes Investigational Site

Santa Ana, California, 92705, United States

Location

Alkermes Investigational Site

Aurora, Colorado, 80045, United States

Location

Alkermes Investigational Site

Colorado Springs, Colorado, 80918, United States

Location

Alkermes Investigational Site

Brandon, Florida, 33511, United States

Location

Alkermes Investigator Site

Brandon, Florida, 33511, United States

Location

Alkermes Investigational Site

Miami, Florida, 33176, United States

Location

Alkermes Investigator Site

Winter Park, Florida, 32789, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30328, United States

Location

Alkermes Investigational Site

Macon, Georgia, 31210, United States

Location

Alkermes Investigational Site

Stockbridge, Georgia, 30281, United States

Location

Alkermes Investigator Site

Peoria, Illinois, 61637, United States

Location

Alkermes Investigator Site

Lansing, Michigan, 48911, United States

Location

Alkermes Investigator Site

Sterling Heights, Michigan, 48314, United States

Location

Alkermes Investigator Site

Lincoln, Nebraska, 68506, United States

Location

Alkermes Investigational Site

Middletown, New Jersey, 07748, United States

Location

Alkermes Investigational Site

Denver, North Carolina, 28037, United States

Location

Alkermes Investigational Site

Huntersville, North Carolina, 28708, United States

Location

Alkermes Investigator Site

Canton, Ohio, 44718, United States

Location

Alkermes Investigational Site

Cincinnati, Ohio, 45227, United States

Location

Alkermes Investigational Site

Cincinnati, Ohio, 45245, United States

Location

Alkermes Investigational Site

Dublin, Ohio, 43017, United States

Location

Alkermes Investigational Site

Wyomissing, Pennsylvania, 19610, United States

Location

Alkermes Investigational Site

Columbia, South Carolina, 29201, United States

Location

Alkermes Investigational Site

Austin, Texas, 78731, United States

Location

Alkermes Investigational Site

San Antonio, Texas, 78229, United States

Location

Alkermes Investigational Site

The Woodlands, Texas, 77380, United States

Location

Alkermes Investigator Site

Macquarie Park, New South Wales, 2113, Australia

Location

Alkermes Investigator Site

Bedford Park, South Australia, 5042, Australia

Location

Alkermes Investigational Site

Alken, 3570, Belgium

Location

Alkermes Investigational Site

Bruges, 8000, Belgium

Location

Alkermes Investigational Site

Namur, 5101, Belgium

Location

Alkermes Investigational Site

Prague, 128 21, Czechia

Location

Alkermes Investigational Site

Bordeaux, 33000, France

Location

Alkermes Investigational Site

Montpellier, 34295, France

Location

Alkermes Investigational Site

Bologna, 40139, Italy

Location

Alkermes Investigational Site

Milan, 20127, Italy

Location

Alkermes Investigational Site

Verona, 37134, Italy

Location

Alkermes Investigational Site

Heemstede, 2103 SW, Netherlands

Location

Alkermes Investigational Site

Zwolle, 8025 BV, Netherlands

Location

Alkermes Investigational Site

Barcelona, 08036, Spain

Location

Alkermes Investigational Site

Madrid, 28036, Spain

Location

Alkermes Investigational Site

Madrid, 28043, Spain

Location

Related Links

• Vibrance-1 Study

MeSH Terms

Conditions

Narcolepsy; Cataplexy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Study Medical Director, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 11, 2024
• Study Start: March 28, 2024
• Primary Completion: June 19, 2025
• Study Completion: July 31, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

IT (3); FR (2); ES (3); AU (2); BE (3); CZ (1); US (29); NL (2)