NarcolepsyPhase 2CONCERTNCT03881852
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
A Phase 2 study testing AXS-12 (Reboxetine) in people with Narcolepsy and Cataplexy Narcolepsy, run by Axsome Therapeutics, Inc. at 14 sites in United States.
Trial summary
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Narcolepsy, Cataplexy Narcolepsy, Excessive 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
- 21 participants
- Where
- 14 sitesUnited States
- Study dates
- 5 Apr 2019to 27 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female subjects between 18 and 70 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
14 sites in 1 country.
14 sites in 1 country
United States14 sites
CONCERT Study Site
Alameda, California, 94501
CONCERT Study Site
Austin, Texas, 78731
CONCERT Study Site
Birmingham, Alabama, 35213
CONCERT Study Site
Boulder, Colorado, 80301
CONCERT Study Site
Chevy Chase, Maryland, 20815
CONCERT Study Site
Cincinnati, Ohio, 45219
CONCERT Study Site
Columbia, South Carolina, 29201
CONCERT Study Site
Fort Wayne, Indiana, 46804
CONCERT Study Site
Gainesville, Georgia, 30501
CONCERT Study Site
Miami, Florida, 33126
CONCERT Study Site
San Antonio, Texas, 78229
CONCERT Study Site
Santa Ana, California, 92705
CONCERT Study Site
Stockbridge, Georgia, 30281
CONCERT Study Site
The Bronx, New York, 10467
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.
- Conditions
- Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness
- Being tested
- AXS-12 (Reboxetine), Placebo
- Keywords
- CONCERT, AXS-12, EDS, Cataplexy, Narcolepsy, Axsome, Reboxetine
- Medical subject headings
- Narcolepsy, Disorders of Excessive Somnolence, Cataplexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXS-12 (Reboxetine)Drug
Dosed orally, twice daily for up to 3 weeks
PlaceboDrug
Dosed orally, twice daily for up to 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| AXS-12 (reboxetine) | Experimental | Not described Receives: Drug: AXS-12 (Reboxetine) |
| 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 From Baseline in the Weekly Average Total Number of Cataplexy Attacks
Presented as LSmeans. A positive change is indicative of improvement.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start5 Apr 2019
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 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
- NCT03881852
- Sponsor's protocol ID
- AXS-12-201
- Acronym
- CONCERT
- Status last verified
- May 2026
- First submitted
- 15 Mar 2019
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
- ClinicalTrials.gov ID
- NCT03881852
- Acronym / sponsor ID
- CONCERT / AXS-12-201
- Conditions
- Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness
- Keywords
- CONCERT, AXS-12, EDS, Cataplexy, Narcolepsy, Axsome, Reboxetine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Posted 24 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXS-12 (reboxetine) | Experimental | Drug: AXS-12 (Reboxetine) |
| 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 (3 listed)
- Male or female subjects between 18 and 70 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)Dosed orally, twice daily for up to 3 weeks | Drug | AXS-12 (reboxetine) |
| PlaceboDosed orally, twice daily for up to 3 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks
Time frame: 2 weeks
Presented as LSmeans. A positive change is indicative of improvement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AXS-12 (Reboxetine) in people with Narcolepsy and Cataplexy Narcolepsy, run by Axsome Therapeutics, Inc. at 14 sites in United States.
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 15 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 14 sites in United States. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in the Weekly Average Total Number of Cataplexy Attacks (time frame: 2 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 15 Jun 2026.