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

Alkermes

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Narcolepsy Type 2; Idiopathic Hypersomnia; Narcolepsy Type 1

Treatments: Drug: ALKS 2680, 8mg; Drug: ALKS 2680, 18mg; Drug: ALKS 2680, 10mg; Drug: ALKS 2680, 6mg; Drug: ALKS 2680, 4mg; Drug: ALKS 2680, 14mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06767683

ALKS 2680-301

Details and patient eligibility

About

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) or Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets

Enrollment: 256 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)
• Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)

Exclusion criteria

• Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

256 participants in 3 patient groups

Narcolepsy Type 1 (NT1)

Experimental group

Treatment:

Drug: ALKS 2680, 4mg

Drug: ALKS 2680, 6mg

Drug: ALKS 2680, 8mg

Narcolepsy Type 2 (NT2)

Experimental group

Treatment:

Drug: ALKS 2680, 14mg

Drug: ALKS 2680, 10mg

Drug: ALKS 2680, 18mg

Idiopathic Hypersomnia (IH)

Experimental group

Treatment:

Drug: ALKS 2680, 14mg

Drug: ALKS 2680, 10mg

Drug: ALKS 2680, 18mg