NarcolepsyPhase 3SYMPHONYNCT05059223
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
A Phase 3 study testing AXS-12 (reboxetine) in people with Narcolepsy and Cataplexy, run by Axsome Therapeutics, Inc. at 50 sites in 2 countries.
Trial summary
This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy 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
- 90 participants
- Where
- 50 sitesin 2 countries
- Study dates
- 15 Sep 2021to 15 Mar 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
- Male or female subjects between 15 and 75 years of age, inclusive
- Primary diagnosis of narcolepsy with cataplexy
- Willing and able to comply with the study requirements
Who cannot join
- Other clinically significant conditions potentially causing EDS
- Clinically significant psychiatric disorders
Trial locations and contacts
50 sites in 2 countries.
50 sites in 2 countries
United States47 sites
Clinical Research Site
Alabaster, Alabama, 35007
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
Brooklyn, New York, 11230
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
Fort Wayne, Indiana, 46804
Clinical Research Site
Gainesville, Georgia, 30501
Clinical Research Site
Gastonia, North Carolina, 28054
Clinical Research Site
Honolulu, Hawaii, 96817
Clinical Research Site
Huntersville, North Carolina, 28078
Clinical Research Site
Kalamazoo, Michigan, 49008
Clinical Research Site
Kissimmee, Florida, 34741
Clinical Research Site
Las Vegas, Nevada, 89106
Clinical Research Site
Macon, Georgia, 31210
Clinical Research Site
Miami, Florida, 33176
Clinical Research Site
Miami Lakes, Florida, 33016
Clinical Research Site
Neptune City, New Jersey, 07753
Clinical Research Site
New Hyde Park, New York, 11040
Clinical Research Site
Newton, Massachusetts, 02459
Clinical Research Site
North Dartmouth, Massachusetts, 02747
Clinical Research Site
Novi, Michigan, 48377
Clinical Research Site
Peoria, Arizona, 85381
Clinical Research Site
Peoria, Illinois, 61637
Clinical Research Site
Phoenix, Arizona, 85054
Clinical Research Site
Redwood City, California, 94063
Clinical Research Site
San Antonio, Texas, 78229
Clinical Research Site
San Diego, California, 92103
Clinical Research Site
Santa Ana, California, 92705
Clinical Research Site
Santa Monica, California, 90404
Clinical Research Site
St Louis, Missouri, 63123
Clinical Research Site
St. Petersburg, Florida, 33707
Clinical Research Site
Stockbridge, Georgia, 30281
Clinical Research Site
Sugar Land, Texas, 77478
Clinical Research Site
Tampa, Florida, 33634
Clinical Research Site
Williamsburg, Virginia, 23188
Clinical Research Site
Winter Park, Florida, 32789
Clinical Research Site
Wyomissing, Pennsylvania, 19610
Canada3 sites
Clinical Research Site
Markham, Ontario, L3R 1A3
Clinical Research Site
Toronto, Ontario, M4P 1P2
Clinical Research Site
Toronto, Ontario, M5S 3A3
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
Read the detailed description
Eligible subjects must have a diagnosis of narcolepsy per the International Classification of Sleep Disorders (ICSD-3), and exhibit symptoms of both cataplexy and EDS. Subjects meeting the entry criteria will be randomized in a 1:1 ratio to receive either AXS-12 or placebo for five weeks.
- 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 5 weeks Receives: Drug: AXS-12 (reboxetine) |
| Placebo | Placebo comparator | Up to 5 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of cataplexy attacks
Average number of cataplexy attacks per week
Measured: Change from Baseline to Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start15 Sep 2021
- Primary completion15 Mar 2024
- Study completion15 Mar 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 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
- NCT05059223
- Sponsor's protocol ID
- AXS-12-301
- Acronym
- SYMPHONY
- Status last verified
- May 2026
- First submitted
- 9 Sep 2021
- Last updated
- 28 May 2026
- 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
- ClinicalTrials.gov ID
- NCT05059223
- Acronym / sponsor ID
- SYMPHONY / AXS-12-301
- 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
- 90 participants (actual)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 28 Sep 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 is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
Detailed description
Eligible subjects must have a diagnosis of narcolepsy per the International Classification of Sleep Disorders (ICSD-3), and exhibit symptoms of both cataplexy and EDS. Subjects meeting the entry criteria will be randomized in a 1:1 ratio to receive either AXS-12 or placebo for five weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXS-12 (reboxetine) | Experimental | Drug: AXS-12 (reboxetine)Up to 5 weeks |
| Placebo | Placebo comparator | Drug: PlaceboUp to 5 weeks |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects between 15 and 75 years of age, inclusive
- Primary diagnosis of narcolepsy with cataplexy
- Willing and able to comply with the study requirements
Key exclusion criteria (2 listed)
- Other clinically significant conditions potentially causing EDS
- Clinically significant psychiatric disorders
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
Frequency of cataplexy attacks
Time frame: Change from Baseline to Week 5
Average number of cataplexy attacks per week
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 28 May 2026.
- SYMPHONY Study WebsiteLink provided by the sponsor.
- 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.
50 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 50 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 3 inclusion and 2 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 28 May 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, 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?
Frequency of cataplexy attacks (time frame: Change from Baseline to Week 5). 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 28 May 2026.