A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)

Alkermes

Status and phase: Enrolling; Phase 2

Conditions: Idiopathic Hypersomnia

Treatments: Drug: ALKS 2680; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06843590

ALKS 2680-203

Details and patient eligibility

About

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
• Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years

Exclusion criteria

• Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle
• Has a history or presence at Visit 1 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
• Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
• Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

96 participants in 4 patient groups, including a placebo group

ALKS 2680, 10 mg

Experimental group

Description:

Oral tablet containing 10 mg of ALKS 2680 for once daily administration

Treatment:

Drug: ALKS 2680

ALKS 2680, 14 mg

Experimental group

Description:

Oral tablet containing 14 mg of ALKS 2680 for once daily administration

Treatment:

Drug: ALKS 2680

ALKS 2680, 18 mg

Experimental group

Description:

Oral tablet containing 18 mg of ALKS 2680 for once daily administration

Treatment:

Drug: ALKS 2680

Placebo

Placebo Comparator group

Description:

Oral placebo tablet for once daily administration

Treatment:

Drug: Placebo