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

• ClinicalTrials.gov Identifier: NCT03881852
• Recruitment Status: Completed
• First Posted: March 20, 2019
• Last Update Posted: December 10, 2020
• Sponsor: Axsome Therapeutics, Inc.
• Information provided by (Responsible Party): Axsome Therapeutics, Inc.

Tracking Information

• First Submitted Date: March 15, 2019
• First Posted Date: March 20, 2019
• Last Update Posted Date: December 10, 2020
• Actual Study Start Date: January 30, 2019
• Actual Primary Completion Date: November 27, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 18, 2019): Number of cataplexy attacks [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 18, 2019)

• Epworth Sleepiness Scale (ESS) [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]
  The ESS is a patient-reported questionnaire consisting 8 questions. Each of the items are rated on a 4-point scale (0-3), based on the usual chances of dozing off or falling asleep while engaged in eight different activities. The total ESS score can range from 0 to 24.
• Maintenance of Wakefulness Test (MWT) [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (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
• 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. The study will enroll approximately 20 patients, all of whom will be treated with AXS-12 for three weeks, and with placebo for three weeks. Eligible patients will be randomized to receive either AXS-12 followed by placebo, or placebo followed by AXS-12. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Narcolepsy
• Cataplexy Narcolepsy
• Excessive Sleepiness

Intervention

• Drug: AXS-12 (Reboxetine)
  Dosed orally, twice daily for up to 3 weeks
• Drug: Placebo
  Dosed orally, twice daily for up to 3 weeks

Study Arms

• Experimental: AXS-12 (reboxetine)
  Intervention: Drug: AXS-12 (Reboxetine)
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 11, 2020): 21
• Original Estimated Enrollment (submitted: March 18, 2019): 20
• Actual Study Completion Date: November 27, 2019
• Actual Primary Completion Date: November 27, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03881852
• Other Study ID Numbers: AXS-12-201
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Axsome Therapeutics, Inc.
• Study Sponsor: Axsome Therapeutics, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Axsome Therapeutics, Inc.
• Verification Date: December 2020