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

Alkermes

Status and phase: Enrolling; Phase 2

Conditions: Narcolepsy Type 2

Treatments: Drug: Placebo; Drug: ALKS 2680

Study type: Interventional

Funder types: Industry

Identifiers

NCT06555783

ALKS 2680-202

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

ALKS 2680, 10 mg

Experimental group

Description:

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

Treatment:

Drug: ALKS 2680

ALKS 2680, 14 mg

Experimental group

Description:

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

Treatment:

Drug: ALKS 2680

ALKS 2680, 18 mg

Experimental group

Description:

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

Treatment:

Drug: ALKS 2680

Placebo

Placebo Comparator group

Description:

Oral tablet containing matching placebo for once daily administration

Treatment:

Drug: Placebo