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Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) (CONCERT)

Primary Purpose

Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AXS-12 (Reboxetine)
Placebo
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Narcolepsy focused on measuring CONCERT, AXS-12, EDS, Cataplexy, Narcolepsy, Axsome, Reboxetine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Other clinically significant conditions potentially causing EDS
  • Clinically significant psychiatric disorders

Sites / Locations

  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site
  • CONCERT Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AXS-12 (reboxetine)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks
Presented as LSmeans. A positive change is indicative of improvement.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2019
Last Updated
August 22, 2023
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03881852
Brief Title
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
Acronym
CONCERT
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness
Keywords
CONCERT, AXS-12, EDS, Cataplexy, Narcolepsy, Axsome, Reboxetine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXS-12 (reboxetine)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AXS-12 (Reboxetine)
Intervention Description
Dosed orally, twice daily for up to 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosed orally, twice daily for up to 3 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks
Description
Presented as LSmeans. A positive change is indicative of improvement.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Exclusion Criteria: Other clinically significant conditions potentially causing EDS Clinically significant psychiatric disorders
Facility Information:
Facility Name
CONCERT Study Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
CONCERT Study Site
City
Alameda
State/Province
California
ZIP/Postal Code
94501
Country
United States
Facility Name
CONCERT Study Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
CONCERT Study Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
CONCERT Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
CONCERT Study Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
CONCERT Study Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
CONCERT Study Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
CONCERT Study Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
CONCERT Study Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
CONCERT Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
CONCERT Study Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
CONCERT Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
CONCERT Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.axsome.com
Description
Axsome Therapeutics Website

Learn more about this trial

Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)

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