Narcolepsy Type 1Phase 2/3NCT06767683
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
A Phase 2/3 study testing ALKS 2680, 4mg, ALKS 2680, 6mg and ALKS 2680, 8mg in people with Narcolepsy Type 1 and Narcolepsy Type 2, run by Alkermes, Inc. at 50 sites in 8 countries.
Trial summary
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- What is being tested?
- ALKS 2680, 4mg, ALKS 2680, 6mg and ALKS 2680, 8mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 786 participants
- Where
- 50 sitesin 8 countries
- Study dates
- 27 Jan 2025to Jun 2030
- Phase
- Phase 2/3
- 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
- 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), ALKS 2680-302 (Brilliance NT1) , ALKS 2680-303 (Brilliance NT2) , ALKS 2680-304 (Brilliance NT 1)
- 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)
Who cannot join
- 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
Trial locations and contacts
50 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
50 sites in 8 countries
United States34 sites, 34 recruiting
- Recruiting
Alkermes Investigational Site
Abington, Pennsylvania, 19001
- Recruiting
Alkermes Investigational Site
Atlanta, Georgia, 30328
- Recruiting
Alkermes Investigational Site
Austin, Texas, 78731
- Recruiting
Alkermes Investigational Site
Boulder, Colorado, 80309
- Recruiting
Alkermes Investigational Site
Brandon, Florida, 33511
- Recruiting
Alkermes Investigational Site
Canton, Ohio, 44718
- Recruiting
Alkermes Investigational Site
Cincinnati, Ohio, 45212
- Recruiting
Alkermes Investigational Site
Cincinnati, Ohio, 45245
- Recruiting
Alkermes Investigational Site
Colorado Springs, Colorado, 80918
- Recruiting
Alkermes Investigational Site
Columbia, South Carolina, 29201
- Recruiting
Alkermes Investigational Site
Cullman, Alabama, 35055
- Recruiting
Alkermes Investigational Site
Dallas, Texas, 75251
- Recruiting
Alkermes Investigational Site
Denver, North Carolina, 28037
- Recruiting
Alkermes Investigational Site
Dublin, Ohio, 43017
- Recruiting
Alkermes Investigational Site
Huntersville, North Carolina, 28708
- Recruiting
Alkermes Investigational Site
Kansas City, Kansas, 66160
- Recruiting
Alkermes Investigational Site
Lansing, Michigan, 48911
- Recruiting
Alkermes Investigational Site
Lincoln, Nebraska, 68506
- Recruiting
Alkermes Investigational Site
Little Rock, Arkansas, 72211
- Recruiting
Alkermes Investigational Site
Los Angeles, California, 90025
- Recruiting
Alkermes Investigational Site
Macon, Georgia, 31210
- Recruiting
Alkermes Investigational Site
Madison, Wisconsin, 53706
- Recruiting
Alkermes Investigational Site
Miami, Florida, 33176
- Recruiting
Alkermes Investigational Site
Middletown, New Jersey, 07748
- Recruiting
Alkermes Investigational Site
Peoria, Illinois, 61637
- Recruiting
Alkermes Investigator Site
Phoenix, Arizona, 85054
- Recruiting
Alkermes Investigational Site
San Antonio, Texas, 78229
- Recruiting
Alkermes Investigator Site
San Francisco, California, 94158
- Recruiting
Alkermes Investigational Site
Stanford, California, 94305
- Recruiting
Alkermes Investigational Site
Sterling Heights, Michigan, 48314
- Recruiting
Alkermes Investigational Site
Stockbridge, Georgia, 30281
- Recruiting
Alkermes Investigational Site
Sugar Land, Texas, 77478
- Recruiting
Alkermes Investigational Site
Winter Park, Florida, 32789
- Recruiting
Alkermes Investigational Site
Wyomissing, Pennsylvania, 19610
Australia3 sites, 3 recruiting
- Recruiting
Alkermes Investigational Site
Bedford Park, South Australia, 5042
- Recruiting
Alkermes Investigational Site
Clayton, Victoria, 3168
- Recruiting
Alkermes Investigational Site
Sydney, New South Wales, 2113
Belgium3 sites, 3 recruiting
- Recruiting
Alkermes Investigational Site
Alken, 3570
- Recruiting
Alkermes Investigational Site
Bruges, Brugge, 8000
- Recruiting
Alkermes Investigational Site
Namur, 5101
Italy3 sites, 3 recruiting
- Recruiting
Alkermes Investigational Site
Bologna, 40139
- Recruiting
Alkermes Investigational Site
Milan, 20127
- Recruiting
Alkermes Investigational Site
Verona, 37134
Spain3 sites, 3 recruiting
- Recruiting
Alkermes Investigational Site
Barcelona, 08036
- Recruiting
Alkermes Investigational Site
Madrid, Madrid, 28036
- Recruiting
Alkermes Investigational Site
Madrid, 28043
France2 sites, 2 recruiting
- Recruiting
Alkermes Investigational Site
Bordeaux, 33000
- Recruiting
Alkermes Investigational Site
Montpellier, Herault, 34295
Czechia1 site, 1 recruiting
- Recruiting
Alkermes Investigational Site
Prague, 128 21
Netherlands1 site, 1 recruiting
- Recruiting
Alkermes Investigational Site
Zwolle, 8025
About this study
Official 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
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Being tested
- ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg, ALKS 2680, 10mg, ALKS 2680, 14mg
- Keywords
- Narcolepsy, Narcolepsy Type 1, Narcolepsy Type 2, NT1, NT2, orexin-2 receptor agonist, sleep, sleep disorder, excessive daytime sleepiness, IH, Idiopathic Hypersomnia
- Medical subject headings
- Idiopathic Hypersomnia, 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 2680, 4mgDrug
Oral tablet containing 4 mg of ALKS 2680 for once daily administration
ALKS 2680, 6mgDrug
Oral tablet containing 6 mg of ALKS 2680 for once daily administration
ALKS 2680, 8mgDrug
Oral tablet containing 8 mg of ALKS 2680 for once daily administration
ALKS 2680, 10mgDrug
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
ALKS 2680, 14mgDrug
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
ALKS 2680, 18mgDrug
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
| Study group | Role | What they receive |
|---|---|---|
| Narcolepsy Type 1 (NT1) | Experimental | Not described Receives: Drug: ALKS 2680, 4mg; Drug: ALKS 2680, 6mg; Drug: ALKS 2680, 8mg |
| Narcolepsy Type 2 (NT2) | Experimental | Not described Receives: Drug: ALKS 2680, 10mg; Drug: ALKS 2680, 14mg; Drug: ALKS 2680, 18mg |
| Idiopathic Hypersomnia (IH) | Experimental | Not described Receives: Drug: ALKS 2680, 10mg; Drug: ALKS 2680, 14mg; Drug: ALKS 2680, 18mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Measured: Up to 248 Weeks
Secondary outcomes (4)
Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT)
Measured: Baseline to Week 24
Change in Epworth Sleepiness Scale (ESS)
Measured: Baseline to up to week 240
Change in weekly cataplexy rate (WCR)
Measured: Baseline up to week 240
Change in Idiopathic Hypersomnia Severity Scale (IHSS)
Only applicable for IH participants
Measured: Baseline up to week 240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start27 Jan 2025
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 786 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
- NCT06767683
- Sponsor's protocol ID
- ALKS 2680-301
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2025
- Last updated
- 9 Oct 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06767683
- Acronym / sponsor ID
- ALKS 2680-301
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Keywords
- Narcolepsy, Narcolepsy Type 1, Narcolepsy Type 2, NT1, NT2, orexin-2 receptor agonist, sleep, sleep disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 786 participants (estimated)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 10 Jan 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 continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Narcolepsy Type 1 (NT1) | Experimental | Drug: ALKS 2680, 4mg, Drug: ALKS 2680, 6mg, Drug: ALKS 2680, 8mg |
| Narcolepsy Type 2 (NT2) | Experimental | Drug: ALKS 2680, 10mg, Drug: ALKS 2680, 14mg, Drug: ALKS 2680, 18mg |
| Idiopathic Hypersomnia (IH) | Experimental | Drug: ALKS 2680, 10mg, Drug: ALKS 2680, 14mg, Drug: ALKS 2680, 18mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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), ALKS 2680-302 (Brilliance NT1) , ALKS 2680-303 (Brilliance NT2) , ALKS 2680-304 (Brilliance NT 1)
- 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)
Key exclusion criteria (3 listed)
- 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
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 2680, 4mgOral tablet containing 4 mg of ALKS 2680 for once daily administration | Drug | Narcolepsy Type 1 (NT1) |
| ALKS 2680, 6mgOral tablet containing 6 mg of ALKS 2680 for once daily administration | Drug | Narcolepsy Type 1 (NT1) |
| ALKS 2680, 8mgOral tablet containing 8 mg of ALKS 2680 for once daily administration | Drug | Narcolepsy Type 1 (NT1) |
| ALKS 2680, 10mgOral tablet containing 10 mg of ALKS 2680 for once daily administration | Drug | Idiopathic Hypersomnia (IH), Narcolepsy Type 2 (NT2) |
| ALKS 2680, 14mgOral tablet containing 14 mg of ALKS 2680 for once daily administration | Drug | Idiopathic Hypersomnia (IH), Narcolepsy Type 2 (NT2) |
| ALKS 2680, 18mgOral tablet containing 18 mg of ALKS 2680 for once daily administration | Drug | Idiopathic Hypersomnia (IH), Narcolepsy Type 2 (NT2) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 248 Weeks
4 secondary outcomes
Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT)
Time frame: Baseline to Week 24
Change in Epworth Sleepiness Scale (ESS)
Time frame: Baseline to up to week 240
Change in weekly cataplexy rate (WCR)
Time frame: Baseline up to week 240
Change in Idiopathic Hypersomnia Severity Scale (IHSS)
Time frame: Baseline up to week 240
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 9 Oct 2026.
- 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.
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 2/3 study testing ALKS 2680, 4mg, ALKS 2680, 6mg and ALKS 2680, 8mg in people with Narcolepsy Type 1 and Narcolepsy Type 2, 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 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: looking for participants now, as of the sponsor's last update on 9 Oct 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, Belgium, 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Director, Global Clinical Services (888-235-8008 (US Only), clinicaltrials@alkermes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Up to 248 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 9 Oct 2026.