A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

Phase 2

Recruiting

• Conditions: Narcolepsy Type 2
• Interventions: Drug: ALKS 2680; Drug: Placebo

• Registration Number: NCT06555783
• Lead Sponsor: Alkermes, Inc.

Brief Summary

The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-26
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-08
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 18-70 years of age
• Has a BMI ≥18 and ≤40 kg/m2
• Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.

Additionally, meets the following criteria:

• Has residual excessive daytime sleepiness
• 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

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Exclusion Criteria

• Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALKS 2680, 10 mg	ALKS 2680	Oral tablet containing 10mg of ALKS 2680 for once daily administration
ALKS 2680, 14 mg	ALKS 2680	Oral tablet containing 14mg of ALKS 2680 for once daily administration
ALKS 2680, 18 mg	ALKS 2680	Oral tablet containing 18mg of ALKS 2680 for once daily administration
Placebo	Placebo	Oral tablet containing matching placebo for once daily administration

Primary Outcome Measures

Name	Time	Method
Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)	Baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
Change in Epworth Sleepiness Scale (ESS)	Baseline to week 8	Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days.
Incidence of adverse events	Up to 21 weeks

Trial Locations

Locations (2)

Alkermes Investigator Site; 🇦🇺 Bedford Park, South Australia, Australia

Alkermes Investigational Site; 🇺🇸 Peoria, Illinois, United States