A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201) (Vibrance-1)

Alkermes

Status and phase: Active, not recruiting; Phase 2

Conditions: Narcolepsy Type 1

Treatments: Drug: Placebo; Drug: ALKS 2680

Study type: Interventional

Funder types: Industry

Identifiers

NCT06358950

ALKS 2860-201

Details and patient eligibility

About

The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.

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 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria:

  • Is HLA-DQB1*06:02-positive
  • Has residual excessive daytime sleepiness and cataplexy

• 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

4 mg ALKS 2680

Experimental group

Treatment:

Drug: ALKS 2680

6 mg ALKS 2680

Experimental group

Treatment:

Drug: ALKS 2680

8 mg ALKS 2680

Experimental group

Treatment:

Drug: ALKS 2680

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo