NCT03881852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2019

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

March 15, 2019

Results QC Date

December 7, 2022

Last Update Submit

August 22, 2023

Conditions

NarcolepsyCataplexy NarcolepsyExcessive Sleepiness

Keywords

CONCERTAXS-12EDSCataplexyNarcolepsyAxsomeReboxetine

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks

    Presented as LSmeans. A positive change is indicative of improvement.

    2 weeks

Study Arms (2)

AXS-12 (reboxetine)

EXPERIMENTAL
Drug: AXS-12 (Reboxetine)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AXS-12 (Reboxetine)DRUG

Dosed orally, twice daily for up to 3 weeks

AXS-12 (reboxetine)
PlaceboDRUG

Dosed orally, twice daily for up to 3 weeks

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

CONCERT Study Site

Birmingham, Alabama, 35213, United States

Location

CONCERT Study Site

Alameda, California, 94501, United States

Location

CONCERT Study Site

Santa Ana, California, 92705, United States

Location

CONCERT Study Site

Boulder, Colorado, 80301, United States

Location

CONCERT Study Site

Miami, Florida, 33126, United States

Location

CONCERT Study Site

St. Petersburg, Florida, 33707, United States

Location

CONCERT Study Site

Gainesville, Georgia, 30501, United States

Location

CONCERT Study Site

Fort Wayne, Indiana, 46804, United States

Location

CONCERT Study Site

Chevy Chase, Maryland, 20815, United States

Location

CONCERT Study Site

The Bronx, New York, 10467, United States

Location

CONCERT Study Site

Cincinnati, Ohio, 45219, United States

Location

CONCERT Study Site

Columbia, South Carolina, 29201, United States

Location

CONCERT Study Site

Austin, Texas, 78731, United States

Location

CONCERT Study Site

San Antonio, Texas, 78229, United States

Location

Related Links

MeSH Terms

Conditions

NarcolepsyDisorders of Excessive SomnolenceCataplexy

Interventions

Reboxetine

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Caroline Streicher, Executive Director, Clinical Operations
Organization
Axsome Therapeutics, Inc.
cstreicher@axsome.com
212-332-5061

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 20, 2019

Study Start

January 30, 2019

Primary Completion

November 27, 2019

Study Completion

November 27, 2019

Last Updated

August 24, 2023

Results First Posted

August 24, 2023

Record last verified: 2023-08

Locations

US(14)