Narcolepsy Type 1Phase 2Vibrance-1NCT06358950
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
A Phase 2 study testing ALKS 2680 in people with Narcolepsy Type 1, run by Alkermes, Inc. at 45 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Narcolepsy Type 1
- 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
- 92 participants
- Where
- 45 sitesin 8 countries
- Study dates
- 24 Mar 2024to 31 Jul 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 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
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
45 sites in 8 countries.
45 sites in 8 countries
United States29 sites
Alkermes Investigational Site
Atlanta, Georgia, 30328
Alkermes Investigational Site
Aurora, Colorado, 80045
Alkermes Investigational Site
Austin, Texas, 78731
Alkermes Investigational Site
Brandon, Florida, 33511
Alkermes Investigator Site
Brandon, Florida, 33511
Alkermes Investigator Site
Canton, Ohio, 44718
Alkermes Investigational Site
Cincinnati, Ohio, 45227
Alkermes Investigational Site
Cincinnati, Ohio, 45245
Alkermes Investigational Site
Colorado Springs, Colorado, 80918
Alkermes Investigational Site
Columbia, South Carolina, 29201
Alkermes Investigational Site
Denver, North Carolina, 28037
Alkermes Investigational Site
Dublin, Ohio, 43017
Alkermes Investigational Site
Huntersville, North Carolina, 28708
Alkermes Investigator Site
Lansing, Michigan, 48911
Alkermes Investigator Site
Lincoln, Nebraska, 68506
Alkermes Investigational Site
Los Angeles, California, 90025
Alkermes Investigational Site
Macon, Georgia, 31210
Alkermes Investigational Site
Miami, Florida, 33176
Alkermes Investigational Site
Middletown, New Jersey, 07748
Alkermes Investigator Site
Peoria, Illinois, 61637
Alkermes Investigational Site
Redwood City, California, 94063
Alkermes Investigational Site
San Antonio, Texas, 78229
Alkermes Investigator Site
San Francisco, California, 94107
Alkermes Investigational Site
Santa Ana, California, 92705
Alkermes Investigator Site
Sterling Heights, Michigan, 48314
Alkermes Investigational Site
Stockbridge, Georgia, 30281
Alkermes Investigational Site
The Woodlands, Texas, 77380
Alkermes Investigator Site
Winter Park, Florida, 32789
Alkermes Investigational Site
Wyomissing, Pennsylvania, 19610
Belgium3 sites
Alkermes Investigational Site
Alken, 3570
Alkermes Investigational Site
Bruges, 8000
Alkermes Investigational Site
Namur, 5101
Italy3 sites
Alkermes Investigational Site
Bologna, 40139
Alkermes Investigational Site
Milan, 20127
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
France2 sites
Alkermes Investigational Site
Bordeaux, 33000
Alkermes Investigational Site
Montpellier, 34295
Netherlands2 sites
Alkermes Investigational Site
Heemstede, 2103 SW
Alkermes Investigational Site
Zwolle, 8025 BV
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 1
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.
- Conditions
- Narcolepsy Type 1
- Being tested
- ALKS 2680, Placebo
- Keywords
- Narcolepsy, Cataplexy, Orexin
- Medical subject headings
- Narcolepsy, Cataplexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 2680Drug
Oral tablet of ALKS 2680 for once daily administration
PlaceboDrug
Oral tablet containing matching placebo for once daily administration
| Study group | Role | What they receive |
|---|---|---|
| 4 mg ALKS 2680 | Experimental | Not described Receives: Drug: ALKS 2680 |
| 6 mg ALKS 2680 | Experimental | Not described Receives: Drug: ALKS 2680 |
| 8 mg ALKS 2680 | Experimental | Not described Receives: Drug: ALKS 2680 |
| Placebo | Placebo comparator | Not described 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 of Wakefulness Test (MWT) from baseline to Week 6
Measured: Baseline to Week 6
Secondary outcomes (3)
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6
Epsworth Sleepiness Scale is a 4-point scale used to measure excessive sleepiness from 0 (would never doze) to 3 (high chance of "dozing)
Measured: Baseline to Week 6
Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary
Measured: Measured at Week 5 and 6
Incidence of adverse events
Measured: Up to 15 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start24 Mar 2024
- Primary completion19 Jun 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Narcolepsy Type 1Studies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Medical Director, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358950
- Sponsor's protocol ID
- ALKS 2860-201
- Acronym
- Vibrance-1
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Plazzi G, Grunstein RR, Mignot E, Lammers GJ, Plante DT, Buntinx E, Del Rio Villegas R, Chen H, Lovett A, Doane MJ, Hopkinson C, Rege B, Himes J, Dauvilliers Y. Safety, tolerability, and efficacy of alixorexton, a selective orexin 2 receptor agonist for narcolepsy type 1 (Vibrance-1): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2026 Aug 24:S1474-4422(26)00278-4. doi: 10.1016/S1474-4422(26)00278-4. Online ahead of print.
PubMed 42636845
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 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 1
- ClinicalTrials.gov ID
- NCT06358950
- Acronym / sponsor ID
- Vibrance-1 / ALKS 2860-201
- Conditions
- Narcolepsy Type 1
- Keywords
- Narcolepsy, Cataplexy, Orexin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 11 Apr 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 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.
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 |
|---|---|---|
| 4 mg ALKS 2680 | Experimental | Drug: ALKS 2680 |
| 6 mg ALKS 2680 | Experimental | Drug: ALKS 2680 |
| 8 mg ALKS 2680 | Experimental | Drug: ALKS 2680 |
| Placebo | Placebo comparator | Drug: Placebo |
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 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria:
- 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
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 of ALKS 2680 for once daily administration | Drug | 4 mg ALKS 2680, 6 mg ALKS 2680, 8 mg ALKS 2680 |
| PlaceboOral tablet containing matching placebo for once daily administration | Drug | Placebo |
Primary outcome
Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6
Time frame: Baseline to Week 6
3 secondary outcomes
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6
Time frame: Baseline to Week 6
Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary
Time frame: Measured at Week 5 and 6
Incidence of adverse events
Time frame: Up to 15 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 10 Jun 2026.
- Derived from this study: PubMed 42636845Plazzi G, Grunstein RR, Mignot E, Lammers GJ, Plante DT, Buntinx E, Del Rio Villegas R, Chen H, Lovett A, Doane MJ, Hopkinson C, Rege B, Himes J, Dauvilliers Y. Safety, tolerability, and efficacy of alixorexton, a selective orexin 2 receptor agonist for narcolepsy type 1 (Vibrance-1): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2026 Aug 24:S1474-4422(26)00278-4. doi: 10.1016/S1474-4422(26)00278-4. Online ahead of print.
- Vibrance-1 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.
Study Medical Director, MD study director
Alkermes, Inc.
45 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 1, run by Alkermes, Inc. at 45 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Belgium, Italy, Spain, Australia 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 of Wakefulness Test (MWT) from baseline to Week 6 (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06358950, which also lists 1 linked publication.
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 10 Jun 2026.