Clinical trial NCT05972044: A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Keywords: Attention deficit hyperactivity disorder
ADHD
Solriamfetol
Sunosi
Axsome
Non-stimulant therapy
Dopamine norepinephrine reuptake inhibitor
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD.

Detailed description: Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily for 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of ADHD according to DSM-5 criteria.
* Provides written informed consent to participate in the study before the conduct of any study procedures.
* Male or female, aged 18 to 55 inclusive.

Exclusion Criteria:

* Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.

Primary outcomes:
measure: Change from Baseline to Week 6 in the AISRS total score
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Clinical Research Site
state: California
city: Garden Grove
country: United States
facility: Clinical Research Site
state: California
city: Newport Beach
country: United States
facility: Clinical Research Site
state: California
city: Riverside
country: United States
facility: Clinical Research Site
state: California
city: Santa Ana
country: United States
facility: Clinical Research Site
state: California
city: Sherman Oaks
country: United States
facility: Clinical Research Site
state: California
city: Torrance
country: United States
facility: Clinical Research Site
state: California
city: Walnut Creek
country: United States
facility: Clinical Research Site
state: California
city: Colorado Springs
country: United States
facility: Clinical Research Site
state: Colorado
city: Clermont
country: United States
facility: Clinical Research Site
state: Florida
city: Doral
country: United States
facility: Clinical Research Site
state: Florida
city: Gainesville
country: United States
facility: Clinical Research Site
state: Florida
city: Jacksonville
country: United States
facility: Clinical Research Site
state: Florida
city: Lauderhill
country: United States
facility: Clinical Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Marietta
country: United States
facility: Clinical Research Site
state: Georgia
city: Overland Park
country: United States
facility: Clinical Research Site
state: Kansas
city: Boston
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Saint Charles
country: United States
facility: Clinical Research Site
state: Missouri
city: Lincoln
country: United States
facility: Clinical Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Site
state: Nevada
city: Berlin
country: United States
facility: Clinical Research Site
state: New Jersey
city: Cherry Hill
country: United States
facility: Clinical Research Site
state: New Jersey
city: Princeton
country: United States
facility: Clinical Research Site
state: New Jersey
city: Mount Kisco
country: United States
facility: Clinical Research Site
state: New York
city: New York
country: United States
facility: Clinical Research Site
state: New York
city: Raleigh
country: United States
facility: Clinical Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Research Site
state: Ohio
city: Kettering
country: United States
facility: Clinical Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Clinical Research Site
state: Oklahoma
city: Media
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: North Charleston
country: United States
facility: Clinical Research Site
state: South Carolina
city: Memphis
country: United States
facility: Clinical Research Site
state: Tennessee
city: Austin
country: United States
facility: Clinical Research Site
state: Texas
city: Bellaire
country: United States
facility: Clinical Research Site
state: Texas
city: Dallas
country: United States
facility: Clinical Research Site
state: Texas
city: Dallas
country: United States
facility: Clinical Research Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Research Site
state: Texas
city: Draper
country: United States
facility: Clinical Research Site
state: Utah
city: Everett
country: United States
facility: Clinical Research Site
state: Washington
Study officials:
References: