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A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy (SYMPHONY)

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ClinicalTrials.gov Identifier: NCT05059223
Recruitment Status : Completed
First Posted : September 28, 2021
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Study Description
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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

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
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : March 15, 2024
Actual Study Completion Date : March 15, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Frequency of cataplexy attacks [ Time Frame: Change from Baseline to Week 5 ]
    Average number of cataplexy attacks per week


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Axsome Therapeutics, Inc.
More Information
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Additional Information:

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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: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Axsome Therapeutics, Inc.:
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