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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06358950
Registration number
NCT06358950
Ethics application status
Date submitted
2/04/2024
Date registered
11/04/2024
Date last updated
20/05/2025
Titles & IDs
Public title
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
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Scientific 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
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Secondary ID [1]
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ALKS 2860-201
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Universal Trial Number (UTN)
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Trial acronym
Vibrance-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Narcolepsy Type 1
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ALKS 2680
Treatment: Drugs - Placebo
Experimental: 4 mg ALKS 2680 -
Experimental: 6 mg ALKS 2680 -
Experimental: 8 mg ALKS 2680 -
Placebo comparator: Placebo -
Treatment: Drugs: ALKS 2680
Oral tablet of ALKS 2680 for once daily administration
Treatment: Drugs: Placebo
Oral tablet containing matching placebo for once daily administration
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6
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Assessment method [1]
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Timepoint [1]
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Baseline to Week 6
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Secondary outcome [1]
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Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6
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Assessment method [1]
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Epsworth Sleepiness Scale is a 4-point scale used to measure excessive sleepiness from 0 (would never doze) to 3 (high chance of "dozing)
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Timepoint [1]
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Baseline to Week 6
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Secondary outcome [2]
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Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary
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Assessment method [2]
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Timepoint [2]
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Measured at Week 5 and 6
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Secondary outcome [3]
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Incidence of adverse events
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Assessment method [3]
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Timepoint [3]
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Up to 15 Weeks
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Eligibility
Key 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
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Minimum age
18
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2025
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Alkermes Investigator Site - Macquarie Park
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Recruitment hospital [2]
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Alkermes Investigator Site - Bedford Park
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Recruitment postcode(s) [1]
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2113 - Macquarie Park
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Michigan
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United States of America
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Nebraska
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United States of America
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New Jersey
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Belgium
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Alken
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Belgium
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Brugge
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Belgium
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Namur
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Czechia
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Praha
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France
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Bordeaux
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France
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Montpellier
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Italy
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Bologna
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Italy
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Milano
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Italy
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Verona
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Netherlands
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Heemstede
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Netherlands
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Zwolle
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Spain
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Barcelona
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Country [26]
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Spain
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State/province [26]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Alkermes, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06358950
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Medical Director, MD
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Address
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Alkermes, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Global Clinical Services
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Address
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Phone
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US: 888-235-8008
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06358950
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