Narcolepsy Type 2Phase 2Vibrance-2NCT06555783
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
A Phase 2 study testing ALKS 2680 in people with Narcolepsy Type 2, run by Alkermes, Inc. at 47 sites in 8 countries.
Trial summary
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Narcolepsy Type 2
- What is being tested?
- ALKS 2680
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 47 sitesin 8 countries
- Study dates
- 26 Jul 2024to 21 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years of age
- Has a BMI ≥18 and ≤40 kg/m2
- Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.
- Additionally, meets the following criteria:
- Has residual excessive daytime sleepiness
- 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
Who cannot join
- 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 locations and contacts
47 sites in 8 countries.
47 sites in 8 countries
United States33 sites
Alkermes Investigator Site
Abington, Pennsylvania, 19001
Alkermes Investigator Site
Atlanta, Georgia, 30328
Alkermes Investigational Site
Aurora, Colorado, 80045
Alkermes Investigator Site
Austin, Texas, 78731
Alkermes Investigator Site
Brandon, Florida, 33511
Alkermes Investigator Site
Canton, Ohio, 44718
Alkermes Investigator Site
Cincinnati, Ohio, 45212
Alkermes Investigator Site
Cincinnati, Ohio, 45245
Alkermes Investigational Site
Cleveland, Ohio, 44195
Alkermes Investigator Site
Colorado Springs, Colorado, 80918
Alkermes Investigator Site
Columbia, South Carolina, 29201
Alkermes Investigator Site
Cordova, Tennessee, 38108
Alkermes Investigator Site
Denver, North Carolina, 28037
Alkermes Investigator Site
Huntersville, North Carolina, 28078
Alkermes Investigator Site
Lansing, Michigan, 48911
Alkermes Investigator Site
Lincoln, Nebraska, 68506
Alkermes Investigator Site
Little Rock, Arkansas, 72211
Alkermes Investigator Site
Los Angeles, California, 90025
Alkermes Investigational Site
Macon, Georgia, 31210
Alkermes Investigational Site
Madison, Wisconsin, 53792
Alkermes Investigator Site
Miami, Florida, 33176
Alkermes Investigator Site
Middletown, New Jersey, 07748
Alkermes Investigational Site
Peoria, Illinois, 61637
Alkermes Investigational Site
Philadelphia, Pennsylvania, 19107
Alkermes Investigator Site
Redwood City, California, 94063
Alkermes Investigator Site
San Antonio, Texas, 78229
Alkermes Investigator Site
San Francisco, California, 94143
Alkermes Investigator Site
Santa Ana, California, 92705
Alkermes Investigator Site
Sterling Heights, Michigan, 48314
Alkermes Investigator Site
Stockbridge, Georgia, 30281
Alkermes Investigational Site
Sugar Land, Texas, 77478
Alkermes Investigator Site
Winter Park, Florida, 32789
Alkermes Investigator Site
Wyomissing, Pennsylvania, 19610
Italy3 sites
Alkermes Investigational Site
Bologna, BO, 40139
Alkermes Investigational Site
Milan, Metropolitan City Of Milan, 20132
Alkermes Investigational site
Verona, 37134
Spain3 sites
Alkermes Investigational Site
Barcelona, 08036
Alkermes Investigational Site
Madrid, 28036
Alkermes Investigational Site
Madrid, 28043
Australia2 sites
Alkermes Investigator Site
Bedford Park, South Australia, 5042
Alkermes Investigator Site
Macquarie Park, New South Wales, 2113
Belgium2 sites
Alkermes Investigational Site
Alken, 3570
Alkermes Investigational Site
Namur, 5101
France2 sites
Alkermes Investigational Site
Bordeaux, 33076
Alkermes Investigational Site
La Tronche, 38700
About this study
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 2
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.
- Conditions
- Narcolepsy Type 2
- Being tested
- ALKS 2680, Placebo
- Keywords
- Narcolepsy, Narcolepsy Type 2, NT2, Orexin-2 receptor agonist, Sleep, Sleep disorder, Excessive daytime sleepiness
- Medical subject headings
- Narcolepsy, Sleep Wake Disorders, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 2680Drug
Oral tablet containing ALKS 2680
PlaceboDrug
Oral tablet containing placebo for once daily administration
| Study group | Role | What they receive |
|---|---|---|
| ALKS 2680, 10 mg | Experimental | Oral tablet containing 10mg of ALKS 2680 for once daily administration Receives: Drug: ALKS 2680 |
| ALKS 2680, 14 mg | Experimental | Oral tablet containing 14mg of ALKS 2680 for once daily administration Receives: Drug: ALKS 2680 |
| ALKS 2680, 18 mg | Experimental | Oral tablet containing 18mg of ALKS 2680 for once daily administration Receives: Drug: ALKS 2680 |
| Placebo | Placebo comparator | Oral tablet containing matching placebo for once daily administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)
Measured: Baseline to Week 8
Change in Epworth Sleepiness Scale (ESS)
Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days.
Measured: Baseline to week 8
Secondary outcomes (1)
Incidence of adverse events
Measured: Up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start26 Jul 2024
- Primary completion11 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555783
- Sponsor's protocol ID
- ALKS 2680-202
- Acronym
- Vibrance-2
- Status last verified
- Feb 2026
- First submitted
- 13 Aug 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 2
- ClinicalTrials.gov ID
- NCT06555783
- Acronym / sponsor ID
- Vibrance-2 / ALKS 2680-202
- Conditions
- Narcolepsy Type 2
- Keywords
- Narcolepsy, Narcolepsy Type 2, NT2, Orexin-2 receptor agonist, Sleep, Sleep disorder, Excessive daytime sleepiness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALKS 2680, 10 mg | Experimental | Drug: ALKS 2680Oral tablet containing 10mg of ALKS 2680 for once daily administration |
| ALKS 2680, 14 mg | Experimental | Drug: ALKS 2680Oral tablet containing 14mg of ALKS 2680 for once daily administration |
| ALKS 2680, 18 mg | Experimental | Drug: ALKS 2680Oral tablet containing 18mg of ALKS 2680 for once daily administration |
| Placebo | Placebo comparator | Drug: PlaceboOral tablet containing matching placebo for once daily administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-70 years of age
- Has a BMI ≥18 and ≤40 kg/m2
- Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.
- Has residual excessive daytime sleepiness
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALKS 2680Oral tablet containing ALKS 2680 | Drug | ALKS 2680, 10 mg, ALKS 2680, 14 mg, ALKS 2680, 18 mg |
| PlaceboOral tablet containing placebo for once daily administration | Drug | Placebo |
Primary outcome
Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)
Time frame: Baseline to Week 8
Change in Epworth Sleepiness Scale (ESS)
Time frame: Baseline to week 8
Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days.
1 secondary outcome
Incidence of adverse events
Time frame: Up to 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Vibrance-2 StudyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director, MD study director
Alkermes, Inc.
47 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALKS 2680 in people with Narcolepsy Type 2, run by Alkermes, Inc. at 47 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Italy, Spain, Australia, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT) (time frame: Baseline to Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.