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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

Titles & IDs
Public title
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects with Narcolepsy Type 1 (ALKS 2680-201)
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
Secondary ID [1] 0 0
ALKS 2860-201
Universal Trial Number (UTN)
Trial acronym
Vibrance-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Narcolepsy Type 1 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6
Timepoint [1] 0 0
Baseline to Week 6
Secondary outcome [1] 0 0
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6
Timepoint [1] 0 0
Baseline to Week 6
Secondary outcome [2] 0 0
Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary
Timepoint [2] 0 0
Measured at Week 5 and 6
Secondary outcome [3] 0 0
Incidence of adverse events
Timepoint [3] 0 0
Up to 15 Weeks

Eligibility
Key inclusion criteria
* 18-70 years of age
* Has a BMI =18 and =35 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Alkermes Investigator Site - Macquarie Park
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alkermes, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Medical Director, MD
Address 0 0
Alkermes, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Global Clinical Services
Address 0 0
Country 0 0
Phone 0 0
US: 888-235-8008
Fax 0 0
Email 0 0
clinicaltrials@alkermes.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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