SYMPHONY: A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
Sponsor
Axsome Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05059223
Collaborator
(none)
90
44
2
20.5
2
0.1
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Study Type:
Interventional
Anticipated Enrollment
:
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Sep 15, 2021
Anticipated Primary Completion Date
:
Jun 1, 2023
Anticipated Study Completion Date
:
Jun 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AXS-12 (reboxetine) Up to 5 weeks |
Drug: AXS-12 (reboxetine)
AXS-12 tablets, taken twice daily
|
| Placebo Comparator: Placebo Up to 5 weeks |
Drug: Placebo
Placebo tablets, taken twice daily
|
Outcome Measures
Primary Outcome Measures
- Frequency of cataplexy attacks [Change from Baseline to Week 5]
Average number of cataplexy attacks per week
Eligibility Criteria
Criteria
Ages Eligible for Study:
15 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Other clinically significant conditions potentially causing EDS
-
Clinically significant psychiatric disorders
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Site | Alabaster | Alabama | United States | 35007 |
| 2 | Clinical Research Site | Peoria | Arizona | United States | 85381 |
| 3 | Clinical Research Site | Phoenix | Arizona | United States | 85054 |
| 4 | Clinical Research Site | Redwood City | California | United States | 94063 |
| 5 | Clinical Research Site | San Diego | California | United States | 92103 |
| 6 | Clinical Research Site | Santa Ana | California | United States | 92705 |
| 7 | Clinical Research Site | Santa Monica | California | United States | 90404 |
| 8 | Clinical Research Site | Boulder | Colorado | United States | 80301 |
| 9 | Clinical Research Site | Colorado Springs | Colorado | United States | 80918 |
| 10 | Clinical Research Site | Brandon | Florida | United States | 33511 |
| 11 | Clinical Research Site | Clearwater | Florida | United States | 33765 |
| 12 | Clinical Research Site | Kissimmee | Florida | United States | 34741 |
| 13 | Clinical Research Site | Miami | Florida | United States | 33176 |
| 14 | Clinical Research Site | Saint Petersburg | Florida | United States | 33707 |
| 15 | Clinical Research Site | Tampa | Florida | United States | 33634 |
| 16 | Clinical Research Site | Winter Park | Florida | United States | 32789 |
| 17 | Clinical Research Site | Atlanta | Georgia | United States | 30315 |
| 18 | Clinical Research Site | Atlanta | Georgia | United States | 30328 |
| 19 | Clinical Research Site | Macon | Georgia | United States | 31210 |
| 20 | Clinical Research Site | Stockbridge | Georgia | United States | 30281 |
| 21 | Clinical Research Site | Honolulu | Hawaii | United States | 96817 |
| 22 | Clinical Research Site | Peoria | Illinois | United States | 61637 |
| 23 | Clinical Research Site | Fort Wayne | Indiana | United States | 46804 |
| 24 | Clinical Research Site | Chevy Chase | Maryland | United States | 20815 |
| 25 | Clinical Research Site | Newton | Massachusetts | United States | 02459 |
| 26 | Clinical Research Site | North Dartmouth | Massachusetts | United States | 02747 |
| 27 | Clinical Research Site | Kalamazoo | Michigan | United States | 49008 |
| 28 | Clinical Research Site | Novi | Michigan | United States | 48377 |
| 29 | Clinical Research Site | Maplewood | Missouri | United States | 63143 |
| 30 | Clinical Research Site | Las Vegas | Nevada | United States | 89106 |
| 31 | Clinical Research Site | New Hyde Park | New York | United States | 11040 |
| 32 | Clinical Research Site | Denver | North Carolina | United States | 28037 |
| 33 | Clinical Research Site | Gastonia | North Carolina | United States | 28054 |
| 34 | Clinical Research Site | Huntersville | North Carolina | United States | 28078 |
| 35 | Clinical Research Site | Cincinnati | Ohio | United States | 45245 |
| 36 | Clinical Research Site | Wyomissing | Pennsylvania | United States | 19610 |
| 37 | Clinical Research Site | Charleston | South Carolina | United States | 29425 |
| 38 | Clinical Research Site | Columbia | South Carolina | United States | 29201 |
| 39 | Clinical Research Site | Austin | Texas | United States | 78731 |
| 40 | Clinical Research Site | San Antonio | Texas | United States | 78229 |
| 41 | Clinical Research Site | Sugar Land | Texas | United States | 77478 |
| 42 | Clinical Research Site | Markham | Ontario | Canada | L3R 1A3 |
| 43 | Clinical Research Site | Toronto | Ontario | Canada | M4P 1P2 |
| 44 | Clinical Research Site | Toronto | Ontario | Canada | M5S 3A3 |
Sponsors and Collaborators
- Axsome Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05059223
Other Study ID Numbers:
- AXS-12-301
First Posted:
Sep 28, 2021
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Axsome Therapeutics, Inc.
Additional relevant MeSH terms: