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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06767683




Registration number
NCT06767683
Ethics application status
Date submitted
6/01/2025
Date registered
10/01/2025
Date last updated
22/05/2025

Titles & IDs
Public title
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Scientific title
An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia
Secondary ID [1] 0 0
ALKS 2680-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Narcolepsy Type 1 0 0
Narcolepsy Type 2 0 0
Idiopathic Hypersomnia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALKS 2680, 4mg
Treatment: Drugs - ALKS 2680, 6mg
Treatment: Drugs - ALKS 2680, 8mg
Treatment: Drugs - ALKS 2680, 10mg
Treatment: Drugs - ALKS 2680, 14mg
Treatment: Drugs - ALKS 2680, 18mg

Experimental: Narcolepsy Type 1 (NT1) -

Experimental: Narcolepsy Type 2 (NT2) -

Experimental: Idiopathic Hypersomnia (IH) -


Treatment: Drugs: ALKS 2680, 4mg
Oral tablet containing 4 mg of ALKS 2680 for once daily administration

Treatment: Drugs: ALKS 2680, 6mg
Oral tablet containing 6 mg of ALKS 2680 for once daily administration

Treatment: Drugs: ALKS 2680, 8mg
Oral tablet containing 8 mg of ALKS 2680 for once daily administration

Treatment: Drugs: ALKS 2680, 10mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration

Treatment: Drugs: ALKS 2680, 14mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration

Treatment: Drugs: ALKS 2680, 18mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events
Timepoint [1] 0 0
Up to 100 Weeks
Secondary outcome [1] 0 0
Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT)
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [2] 0 0
Change in Epworth Sleepiness Scale (ESS)
Timepoint [2] 0 0
Baseline to 96 Weeks

Eligibility
Key inclusion criteria
* Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)
* Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
27/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2027
Actual
Sample size
Target
256
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Alkermes Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
2113 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Spain
State/province [14] 0 0
Madrid

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
Medical Director
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
Director, Global Clinical Services
Address 0 0
Country 0 0
Phone 0 0
888-235-8008 (US Only)
Fax 0 0
Email 0 0
[email protected]
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/NCT06767683