A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy (SYMPHONY)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05059223 |
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Recruitment Status :
Recruiting
First Posted : September 28, 2021
Last Update Posted : March 7, 2023
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Sponsor:
Axsome Therapeutics, Inc.
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.
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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 |
|---|---|---|
| Narcolepsy Cataplexy Excessive Daytime Sleepiness | Drug: AXS-12 (reboxetine) Drug: Placebo | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | September 15, 2021 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | June 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Narcolepsy
| Arm | Intervention/treatment |
|---|---|
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Experimental: AXS-12 (reboxetine)
Up to 5 weeks
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Drug: AXS-12 (reboxetine)
AXS-12 tablets, taken twice daily |
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Placebo Comparator: Placebo
Up to 5 weeks
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Drug: Placebo
Placebo tablets, taken twice daily |
Primary Outcome Measures :
- Frequency of cataplexy attacks [ Time Frame: Change from Baseline to Week 5 ]Average number of cataplexy attacks per week
Information from the National Library of Medicine
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| Ages Eligible for Study: | 15 Years to 75 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05059223
Contacts
| Contact: Study Director | 212-332-5061 | SYMPHONYstudy@axsome.com |
Locations
| United States, Alabama | |
| Clinical Research Site | Recruiting |
| Alabaster, Alabama, United States, 35007 | |
| United States, Arizona | |
| Clinical Research Site | Recruiting |
| Peoria, Arizona, United States, 85381 | |
| Clinical Research Site | Recruiting |
| Phoenix, Arizona, United States, 85054 | |
| United States, California | |
| Clinical Research Site | Recruiting |
| Redwood City, California, United States, 94063 | |
| Clinical Research Site | Recruiting |
| San Diego, California, United States, 92103 | |
| Clinical Research Site | Recruiting |
| Santa Ana, California, United States, 92705 | |
| Clinical Research Site | Recruiting |
| Santa Monica, California, United States, 90404 | |
| United States, Colorado | |
| Clinical Research Site | Recruiting |
| Boulder, Colorado, United States, 80301 | |
| Clinical Research Site | Recruiting |
| Colorado Springs, Colorado, United States, 80918 | |
| United States, Florida | |
| Clinical Research Site | Recruiting |
| Brandon, Florida, United States, 33511 | |
| Clinical Research Site | Recruiting |
| Clearwater, Florida, United States, 33765 | |
| Clinical Research Site | Recruiting |
| Kissimmee, Florida, United States, 34741 | |
| Clinical Research Site | Recruiting |
| Miami Lakes, Florida, United States, 33016 | |
| Clinical Research Site | Recruiting |
| Miami, Florida, United States, 33176 | |
| Clinical Research Site | Recruiting |
| Saint Petersburg, Florida, United States, 33707 | |
| Clinical Research Site | Recruiting |
| Tampa, Florida, United States, 33634 | |
| Clinical Research Site | Recruiting |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| Clinical Research Site | Recruiting |
| Atlanta, Georgia, United States, 30315 | |
| Clinical Research Site | Recruiting |
| Atlanta, Georgia, United States, 30328 | |
| Clinical Research Site | Recruiting |
| Macon, Georgia, United States, 31210 | |
| Clinical Research Site | Recruiting |
| Stockbridge, Georgia, United States, 30281 | |
| United States, Hawaii | |
| Clinical Research Site | Recruiting |
| Honolulu, Hawaii, United States, 96817 | |
| United States, Illinois | |
| Clinical Research Site | Recruiting |
| Peoria, Illinois, United States, 61637 | |
| United States, Indiana | |
| Clinical Research Site | Recruiting |
| Fort Wayne, Indiana, United States, 46804 | |
| United States, Maryland | |
| Clinical Research Site | Recruiting |
| Chevy Chase, Maryland, United States, 20815 | |
| United States, Massachusetts | |
| Clinical Research Site | Recruiting |
| Newton, Massachusetts, United States, 02459 | |
| Clinical Research Site | Recruiting |
| North Dartmouth, Massachusetts, United States, 02747 | |
| United States, Michigan | |
| Clinical Research Site | Recruiting |
| Kalamazoo, Michigan, United States, 49008 | |
| Clinical Research Site | Recruiting |
| Novi, Michigan, United States, 48377 | |
| United States, Missouri | |
| Clinical Research Site | Recruiting |
| Maplewood, Missouri, United States, 63143 | |
| United States, Nevada | |
| Clinical Research Site | Recruiting |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| Clinical Research Site | Recruiting |
| West Long Branch, New Jersey, United States, 07764 | |
| United States, New York | |
| Clinical Research Site | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| United States, North Carolina | |
| Clinical Research Site | Recruiting |
| Denver, North Carolina, United States, 28037 | |
| Clinical Research Site | Recruiting |
| Gastonia, North Carolina, United States, 28054 | |
| Clinical Research Site | Recruiting |
| Huntersville, North Carolina, United States, 28078 | |
| United States, Ohio | |
| Clinical Research Site | Recruiting |
| Cincinnati, Ohio, United States, 45245 | |
| United States, Pennsylvania | |
| Clinical Research Site | Recruiting |
| Wyomissing, Pennsylvania, United States, 19610 | |
| United States, South Carolina | |
| Clinical Research Site | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Clinical Research Site | Recruiting |
| Columbia, South Carolina, United States, 29201 | |
| United States, Texas | |
| Clinical Research Site | Recruiting |
| Austin, Texas, United States, 78731 | |
| Clinical Research Site | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Clinical Research Site | Recruiting |
| Sugar Land, Texas, United States, 77478 | |
| United States, Virginia | |
| Clinical Research Site | Recruiting |
| Williamsburg, Virginia, United States, 23188 | |
| Canada, Ontario | |
| Clinical Research Site | Recruiting |
| Markham, Ontario, Canada, L3R 1A3 | |
| Clinical Research Site | Recruiting |
| Toronto, Ontario, Canada, M4P 1P2 | |
| Clinical Research Site | Recruiting |
| Toronto, Ontario, Canada, M5S 3A3 | |
Sponsors and Collaborators
Axsome Therapeutics, Inc.
Additional Information:
| Responsible Party: | Axsome Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT05059223 |
| Other Study ID Numbers: |
AXS-12-301 |
| First Posted: | September 28, 2021 Key Record Dates |
| Last Update Posted: | March 7, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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.:
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AXS-12 Narcolepsy Cataplexy |
Excessive daytime sleepiness Reboxetine Axsome |
Additional relevant MeSH terms:
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Narcolepsy Disorders of Excessive Somnolence Cataplexy Sleepiness Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Reboxetine |
Antidepressive Agents Psychotropic Drugs Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs |