Clinical trial NCT06358950: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
Official title: A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 1
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Narcolepsy Type 1
Keywords: Narcolepsy
Cataplexy
Orexin
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6
timeFrame: Baseline to Week 6
measure: Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary
timeFrame: Measured at Week 5 and 6
measure: Incidence of adverse events
timeFrame: Up to 15 Weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Alkermes Investigational Site
state: California
city: Redwood City
country: United States
facility: Alkermes Investigational Site
state: California
city: San Francisco
country: United States
facility: Alkermes Investigator Site
state: California
city: Santa Ana
country: United States
facility: Alkermes Investigational Site
state: California
city: Aurora
country: United States
facility: Alkermes Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Alkermes Investigational Site
state: Colorado
city: Brandon
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Brandon
country: United States
facility: Alkermes Investigator Site
state: Florida
city: Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Alkermes Investigator Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Macon
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Stockbridge
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Peoria
country: United States
facility: Alkermes Investigator Site
state: Illinois
city: Lansing
country: United States
facility: Alkermes Investigator Site
state: Michigan
city: Sterling Heights
country: United States
facility: Alkermes Investigator Site
state: Michigan
city: Lincoln
country: United States
facility: Alkermes Investigator Site
state: Nebraska
city: Middletown
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Denver
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Canton
country: United States
facility: Alkermes Investigator Site
state: Ohio
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Dublin
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Wyomissing
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Alkermes Investigational Site
state: Texas
city: The Woodlands
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Macquarie Park
country: Australia
facility: Alkermes Investigator Site
state: New South Wales
city: Bedford Park
country: Australia
facility: Alkermes Investigator Site
state: South Australia
city: Alken
country: Belgium
facility: Alkermes Investigational Site
city: Brugge
country: Belgium
facility: Alkermes Investigational Site
city: Namur
country: Belgium
facility: Alkermes Investigational Site
city: Praha
country: Czechia
facility: Alkermes Investigational Site
city: Bordeaux
country: France
facility: Alkermes Investigational Site
city: Montpellier
country: France
facility: Alkermes Investigational Site
city: Bologna
country: Italy
facility: Alkermes Investigational Site
city: Milano
country: Italy
facility: Alkermes Investigational Site
city: Verona
country: Italy
facility: Alkermes Investigational Site
city: Heemstede
country: Netherlands
facility: Alkermes Investigational Site
city: Zwolle
country: Netherlands
facility: Alkermes Investigational Site
city: Barcelona
country: Spain
facility: Alkermes Investigational Site
city: Madrid
country: Spain
facility: Alkermes Investigational Site
city: Madrid
country: Spain
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Study Medical Director, MD
role: STUDY_DIRECTOR
References: