NarcolepsyPhase 3NCT05113745
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)
A Phase 3 study testing AXS-12 (reboxetine) in people with Narcolepsy and Cataplexy, run by Axsome Therapeutics, Inc. at 25 sites in 2 countries.
Trial summary
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS). Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- What is being tested?
- AXS-12 (reboxetine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 20 Oct 2021to 15 Nov 2024
- Phase
- Phase 3
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completed the treatment period of Study AXS-12-301
- Willing and able to comply with the study requirements
Who cannot join
- Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigator, would render the subject unsuitable to receive AXS-12
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States24 sites
Clinical Research Site
Atlanta, Georgia, 30315
Clinical Research Site
Atlanta, Georgia, 30328
Clinical Research Site
Austin, Texas, 78731
Clinical Research Site
Boulder, Colorado, 80301
Clinical Research Site
Brandon, Florida, 33511
Clinical Research Site
Charleston, South Carolina, 29425
Clinical Research Site
Chevy Chase, Maryland, 20815
Clinical Research Site
Cincinnati, Ohio, 45245
Clinical Research Site
Clearwater, Florida, 33765
Clinical Research Site
Colorado Springs, Colorado, 80918
Clinical Research Site
Columbia, South Carolina, 29201
Clinical Research Site
Denver, North Carolina, 28037
Clinical Research Site
Doral, Florida, 33122
Clinical Research Site
Gastonia, North Carolina, 28054
Clinical Research Site
Huntersville, North Carolina, 28078
Clinical Research Site
Kalamazoo, Michigan, 49008
Clinical Research Site
Miami Lakes, Florida, 33016
Clinical Research Site
Neptune City, New Jersey, 07753
Clinical Research Site
Novi, Michigan, 48377
Clinical Research Site
Phoenix, Arizona, 85054
Clinical Research Site
San Antonio, Texas, 78229
Clinical Research Site
Stockbridge, Georgia, 30281
Clinical Research Site
Winter Park, Florida, 32789
Clinical Research Site
Wyomissing, Pennsylvania, 19610
About this study
Official title: A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
Read the detailed description
This study is a multi-center trial consisting of a 24-week open-label period, followed by a 4-week double-blind, placebo-controlled, randomized withdrawal period. At the Week 24 visit, subjects will be randomized in a 1:1 ratio either to continue to receive AXS-12 or to switch to placebo, for the next 4 weeks. Eligible subjects will have previously participated in the AXS-12-301 study.
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Being tested
- AXS-12 (reboxetine), Placebo
- Keywords
- AXS-12, Narcolepsy, Cataplexy, Excessive Daytime Sleepiness, Reboxetine, Axsome
- Medical subject headings
- Narcolepsy, Cataplexy, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXS-12 (reboxetine)Drug
AXS-12 tablets, taken twice daily
PlaceboDrug
Placebo tablets, taken twice daily
| Study group | Role | What they receive |
|---|---|---|
| AXS-12 (reboxetine) | Experimental | * Up to 24 weeks in open-label period
* Up to 4 weeks in randomized double-blind period Receives: Drug: AXS-12 (reboxetine) |
| Placebo | Placebo comparator | Up to 4 weeks in randomized double-blind period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety as measured by the incidence of treatment-emergent adverse events
Measured: Up to 28 weeks
Efficacy as measured by change in frequency of cataplexy attacks from baseline.
Measured: Baseline to Week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start20 Oct 2021
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label treatment period, followed by a double-blind treatment period.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113745
- Sponsor's protocol ID
- AXS-12-302
- Status last verified
- Nov 2025
- First submitted
- 29 Oct 2021
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
- ClinicalTrials.gov ID
- NCT05113745
- Acronym / sponsor ID
- AXS-12-302
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Keywords
- AXS-12, Narcolepsy, Cataplexy, Excessive Daytime Sleepiness, Reboxetine, Axsome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 9 Nov 2021 (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.
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
Detailed description
This study is a multi-center trial consisting of a 24-week open-label period, followed by a 4-week double-blind, placebo-controlled, randomized withdrawal period. At the Week 24 visit, subjects will be randomized in a 1:1 ratio either to continue to receive AXS-12 or to switch to placebo, for the next 4 weeks. Eligible subjects will have previously participated in the AXS-12-301 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Open-label treatment period, followed by a double-blind treatment period.
| Arm | Type | Receives |
|---|---|---|
| AXS-12 (reboxetine) | Experimental | Drug: AXS-12 (reboxetine)* Up to 24 weeks in open-label period * Up to 4 weeks in randomized double-blind period |
| Placebo | Placebo comparator | Drug: PlaceboUp to 4 weeks in randomized double-blind period |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Completed the treatment period of Study AXS-12-301
- Willing and able to comply with the study requirements
Key exclusion criteria (1 listed)
- Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigator, would render the subject unsuitable to receive AXS-12
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 |
|---|---|---|
| AXS-12 (reboxetine)AXS-12 tablets, taken twice daily | Drug | AXS-12 (reboxetine) |
| PlaceboPlacebo tablets, taken twice daily | Drug | Placebo |
Primary outcome
Long-term safety as measured by the incidence of treatment-emergent adverse events
Time frame: Up to 28 weeks
Efficacy as measured by change in frequency of cataplexy attacks from baseline.
Time frame: Baseline to Week 27
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 13 Nov 2025.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AXS-12 (reboxetine) in people with Narcolepsy and Cataplexy, run by Axsome Therapeutics, Inc. at 25 sites in 2 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 1 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 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. 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 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?
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?
Long-term safety as measured by the incidence of treatment-emergent adverse events (time frame: Up to 28 weeks). 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 13 Nov 2025.