Idiopathic HypersomniaPhase 2Vibrance-3NCT06843590
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
A Phase 2 study testing ALKS 2680 in people with Idiopathic Hypersomnia, run by Alkermes, Inc. at 50 sites in 8 countries.
Trial summary
The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Idiopathic Hypersomnia
- 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
- 126 participants
- Where
- 50 sitesin 8 countries
- Study dates
- 22 May 2025to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
- Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years
Who cannot join
- Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle
- Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study
- Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
- Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Trial locations and contacts
50 sites in 8 countries.
50 sites in 8 countries
United States34 sites
Alkermes Investigator Site
Atlanta, Georgia, 30328
Alkermes Investigator Site
Austin, Texas, 78731
Alkermes Investigational Site
Boston, Massachusetts, 02215
Alkermes Investigational Site
Boulder, Colorado, 80301
Alkermes Investigator Site
Brandon, Florida, 33511
Alkermes Investigator Site
Canton, Ohio, 44718
Alkermes Investigator Site
Cincinnati, Ohio, 45245
Alkermes Investigator Site
Cleveland, Ohio, 44195
Alkermes Investigator Site
Colorado Springs, Colorado, 80918
Alkermes Investigator Site
Columbia, South Carolina, 29201
Alkermes Investigator Site
Cullman, Alabama, 35055
Alkermes Investigator Site
Danville, Pennsylvania, 17822
Alkermes Investigator Site
Denver, North Carolina, 28037
Alkermes Investigator Site
Huntersville, North Carolina, 28078
Alkermes Investigator Site
Kansas City, Kansas, 66160
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 Investigator Site
Macon, Georgia, 31210
Alkermes Investigator Site
Madison, Wisconsin, 53792
Alkermes Investigator Site
Miami, Florida, 33176
Alkermes Investigator Site
Middletown, New Jersey, 07748
Alkermes Investigator Site
Peoria, Illinois, 61637
Alkermes Investigator Site
Philadelphia, Pennsylvania, 19107
Alkermes Investigator Site
Phoenix, Arizona, 85054
Alkermes Investigator Site
Redwood City, California, 94063
Alkermes Investigator Site
San Antonio, Texas, 78229
Alkermes Investigator Site
San Francisco, California, 94143
Alkermes Investigator Site
Stockbridge, Georgia, 30281
Alkermes Investigator Site
Sugar Land, Texas, 77478
Alkermes Investigator Site
Sugarland, Texas, 77478
Alkermes Investigator Site
Winter Park, Florida, 32789
Alkermes Investigator Site
Wyomissing, Pennsylvania, 19610
Australia3 sites
Alkermes Investigator Site
Bedford Park, South Australia, 5042
Alkermes Investigator Site
Clayton, Victoria, 3168
Alkermes Investigator Site
Sydney, New South Wales, 2113
France3 sites
Alkermes Investigator Site
Bordeaux, Gironde, 33000
Alkermes Investigator Site
Grenoble, Isere, 38043
Alkermes Investigator Site
Montpellier, Herault, 34295
Italy3 sites
Alkermes Investigator Site
Bologna, 40139
Alkermes Investigator Site
Milan, 20127
Alkermes Investigator Site
Verona, 37134
Spain3 sites
Alkermes Investigator Site
Barcelona, 8036
Alkermes Investigator Site
Madrid, 28036
Alkermes Investigator Site
Madrid, 28043
Belgium2 sites
Alkermes Investigator Site
Alken, 3570
Alkermes Investigator Site
Namur, 5101
About this study
Official title: A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)
The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
- Conditions
- Idiopathic Hypersomnia
- Being tested
- ALKS 2680, Placebo
- Keywords
- Idiopathic Hypersomnia, IH, sleep, sleep disorder, orexin-2 receptor agonist, excessive daytime sleepiness
- Medical subject headings
- Idiopathic Hypersomnia, 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 for daily, oral administration
PlaceboDrug
Oral placebo tablet for daily administration
| Study group | Role | What they receive |
|---|---|---|
| ALKS 2680, 10 mg- Part A | Experimental | Oral tablet containing 10 mg of ALKS 2680 for once daily administration Receives: Drug: ALKS 2680 |
| ALKS 2680, 14 mg -Part A | Experimental | Oral tablet containing 14 mg of ALKS 2680 for once daily administration Receives: Drug: ALKS 2680 |
| ALKS 2680, 18 mg- Part A | Experimental | Oral tablet containing 18 mg of ALKS 2680 for once daily administration Receives: Drug: ALKS 2680 |
| Placebo- Part A | Placebo comparator | Oral placebo tablet for once daily administration Receives: Drug: Placebo |
| ALKS 2680 Dose 1- Part B | Experimental | Oral tablets of ALKS 2680 taken, orally, daily Receives: Drug: ALKS 2680 |
| Placebo - Part B | Placebo comparator | Oral tablets of placebo taken, orally, daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level
Measured: Up to 8 weeks
Secondary outcomes (2)
Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level
Measured: Up to 8 weeks
Incidence of treatment emergent adverse events
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start22 May 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic HypersomniaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843590
- Sponsor's protocol ID
- ALKS 2680-203
- Acronym
- Vibrance-3
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2025
- Last updated
- 25 Sep 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)
- ClinicalTrials.gov ID
- NCT06843590
- Acronym / sponsor ID
- Vibrance-3 / ALKS 2680-203
- Conditions
- Idiopathic Hypersomnia
- Keywords
- Idiopathic Hypersomnia, IH, sleep, sleep disorder, orexin-2 receptor agonist, excessive daytime sleepiness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 May 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 25 Feb 2025 (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 daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ALKS 2680, 10 mg- Part A | Experimental | Drug: ALKS 2680Oral tablet containing 10 mg of ALKS 2680 for once daily administration |
| ALKS 2680, 14 mg -Part A | Experimental | Drug: ALKS 2680Oral tablet containing 14 mg of ALKS 2680 for once daily administration |
| ALKS 2680, 18 mg- Part A | Experimental | Drug: ALKS 2680Oral tablet containing 18 mg of ALKS 2680 for once daily administration |
| Placebo- Part A | Placebo comparator | Drug: PlaceboOral placebo tablet for once daily administration |
| ALKS 2680 Dose 1- Part B | Experimental | Drug: ALKS 2680Oral tablets of ALKS 2680 taken, orally, daily |
| Placebo - Part B | Placebo comparator | Drug: PlaceboOral tablets of placebo taken, orally, daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
- Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years
Key exclusion criteria (4 listed)
- Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle
- Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study
- Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
- Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
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 for daily, oral administration | Drug | ALKS 2680 Dose 1- Part B, ALKS 2680, 10 mg- Part A, ALKS 2680, 14 mg -Part A, ALKS 2680, 18 mg- Part A |
| PlaceboOral placebo tablet for daily administration | Drug | Placebo - Part B, Placebo- Part A |
Primary outcome
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level
Time frame: Up to 8 weeks
2 secondary outcomes
Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level
Time frame: Up to 8 weeks
Incidence of treatment emergent adverse events
Time frame: Up to 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Vibrance Study for IHLink 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 study director
Alkermes, Inc.
50 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 Idiopathic Hypersomnia, run by Alkermes, Inc. at 50 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Australia, France, Italy, Spain 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?
This study is still under way. Results are not available in the source record yet.
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 Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level (time frame: Up to 8 weeks). 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 25 Sep 2026.