A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy

Phase 2/3

Recruiting

• Conditions: Narcolepsy Type 1 and Type 2

• Registration Number: 2024-519822-18-00
• Lead Sponsor: Alkermes Inc.

Brief Summary

The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Study Start: 2025-01-27
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-29
• Last Update Posted: 2025-07-02
• Primary Completion: 2028-06
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Not specified
• Target Recruitment: 58

Inclusion Criteria

Is willing and able to provide informed consent before study participation, as required by local regulations and IEC requirements.

Was eligible for and has completed the EoT Visit of an ALKS 2680 eligible parent study in NT1 or NT2. The current eligible ALKS 2680 studies are ALKS 2680-201 and ALKS 2680-202.

Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: a. Certain lifestyle considerations and restrictions detailed in the Section 5.3 b. Adherence to contraception guidance (examples include but are not limited to: IUD, hormonal contraception, and condom use, as applicable). For further details, please refer to Section 10.4.2. c. Adherence to study schedule, actigraphy wear requirements, and diary completion

Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, including EDS and cataplexy, as applicable, for 5 half-lives prior to Day 1 (this discontinuation requirement is only applicable for re-entry subjects), and for the duration of study (for all subjects). See list of prohibited medications in Section 6.9.1. Subjects who roll over directly into the study from either ALKS 2680-201 or ALKS 2680-202 do not need to undergo medication discontinuation and will continue on ALKS 2680 uninterrupted.

In the opinion of the investigator, the subject has experienced improvement in narcolepsy symptoms during the Open Label Extension Period of an ALKS 2680 eligible parent study in NT1 or NT2.

Exclusion Criteria

Developed a new clinically significant health condition, ECG or laboratory abnormality, or finding in the eye and vision examination during the parent study or has an anticipated eye surgery during the course of the study that, in the opinion of the Investigator or Sponsor, may impact the subject’s participation in the study.

Has a history or presence at Screening of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject’s ability to complete the study. This includes but is not necessarily limited to the following: a. Uncontrolled or unstable hypothyroidism or diabetes mellitus b. Clinically significant hepatic or renal disease c. Significant neurological disorder, including dementia, neurodegeneration, stroke, epilepsy, or seizures (excluding pediatric febrile seizures)

Is at a current risk of suicidal behavior; or has a “Yes” to questions 4 or 5 on the C-SSRS and/or had a suicide attempt in the period within 12 months prior to Screening.

Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at Screening. See Section 10.2 for details.

If a re-entry subject, presence of the following laboratory abnormalities at Screening (one repeat is allowed at the Investigator’s discretion), including: a. Elevated liver function tests (ALT, AST) >1.5 times the upper limit of normal b. Positive serology test for HbsAg or hepatitis C antibody confirmed by RNA testing at Screening c. Renal creatinine clearance (Cockcroft-Gault Equation) ≤50 mL/min d. HbA1c ≥6.5%

Is currently taking (or is anticipated to take) any prohibited prescription or OTC medications listed in Section 6.9.1, or will not be able to comply with provided washout requirements.

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.

Is employed by Alkermes, the CRO, or study site (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family (ie, a spouse, parent, sibling, or child, whether biological or legally adopted) of an Alkermes, CRO, or study site employee.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events (TEAEs)		Treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
Clinical laboratory assessments		Clinical laboratory assessments
Vital signs		Vital signs
Safety electrocardiogram (ECG)		Safety electrocardiogram (ECG)
Columbia-Suicide Severity Rating Scale (C-SSRS)		Columbia-Suicide Severity Rating Scale (C-SSRS)
Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 24		Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 24
Change in Epworth Sleepiness Scale (ESS) from baseline through the Treatment Period		Change in Epworth Sleepiness Scale (ESS) from baseline through the Treatment Period
Change in the weekly cataplexy rate (WCR) from baseline through the Treatment Period (for NT1 subjects only)		Change in the weekly cataplexy rate (WCR) from baseline through the Treatment Period (for NT1 subjects only)

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇪🇸 Madrid, Spain