Clinical trial NCT06741228: A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults With Generalized Anxiety Disorder - Voyage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Lead sponsor: Mind Medicine, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Voyage

Detailed description: The study will enroll up to 200 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM-A total score of at least 20 at Screening and Baseline without clinically relevant medical or psychiatric history.

The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating MM120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with MM120 based on pre-specified safety and symptom severity criteria.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of GAD per DSM-5
2. Male or female aged 18 to 74
3. HAM-A Total Score ≥20

Exclusion Criteria:

1. Certain psychiatric disorders (other than generalized anxiety disorder)
2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
4. Any clinically significant unstable illness

Primary outcomes:
measure: Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1
timeFrame: Week 8, Week 4, Week 2, and Week 1
measure: HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period
timeFrame: Baseline to Week 12
measure: HAM-A remission (total score ≤7) at each timepoint assessed during the 12-week double-blind treatment period
timeFrame: Baseline to Week 12
measure: Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period
timeFrame: Day 2 to Week 12
measure: Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score
timeFrame: Baseline to Week 12
measure: Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score
timeFrame: Baseline to Week 12
measure: Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -Montgomery-Åsberg Depression Rating Scale (MADRS) total score
timeFrame: Baseline to Week 12
measure: Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: Baseline to Week 12
measure: Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -EuroQol-5 Dimensions - 5 Levels (EQ-5D-5L)
timeFrame: Baseline to Week 12
measure: Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) total score at each timepoint assessed during the double-blind period
timeFrame: Baseline to Week 12
measure: Percent of men and women with normal and abnormal sexual functioning at each timepoint assessed during the double-blind period
timeFrame: Baseline to Week 12
measure: Percent of participants requiring one, two, three, four, or five doses of MM120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period
timeFrame: Day 1 to Week 52
measure: Time to first treatment or lack of efficacy in the open-label period (Part B)
timeFrame: Day 1 to Week 52
measure: Need for MM120 treatment as assessed by the average number of MM120 treatments during the study
timeFrame: Day 1 to Week 52
measure: HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 40-week open-label period
timeFrame: 40 week open label period
measure: HAM-A remission (total score ≤7) at each timepoint assessed during the 40-week open-label period
timeFrame: 40 week open label period
measure: Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score
timeFrame: Baseline to Week 52
measure: Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score
timeFrame: Baseline to Week 52
measure: Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in MADRS total score
timeFrame: Baseline to Week 52
measure: Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in WPAI
timeFrame: Baseline to Week 52
measure: Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in EQ-5D-5L
timeFrame: Baseline to Week 52
measure: CSFQ-14 total score at each timepoint assessed during the open-label period
timeFrame: 40 week open label period
measure: Percent men and women with normal and abnormal sexual functioning at each timepoint assessed during the open-label period
timeFrame: 40 week open label period
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Lighthouse Psychiatry
state: Arizona
city: La Jolla
country: United States
facility: Kadima Neuropsychiatry Institute
state: California
city: San Francisco
country: United States
facility: UCSF Department of Neurology
state: California
city: Santa Monica
country: United States
facility: Pacific Neuroscience Institute
state: California
city: Denver
country: United States
facility: Mountain View
state: Colorado
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites - Lakeland CRU
state: Florida
city: Lauderhill
country: United States
facility: Segal Trials
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute
state: Illinois
city: Boston
country: United States
facility: Copley Clinical
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
city: New York
country: United States
facility: Spectrum Neuroscience and Treatment Institute
state: New York
city: New York
country: United States
facility: New York State Psychiatric Institute (NYSPI)
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Lutheran Hospital
state: Ohio
city: Portland
country: United States
facility: Summit Headlands LLC
state: Oregon
city: Moosic
country: United States
facility: Scranton Medical Institute
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Dell Medical School, University of Texas at Austin
state: Texas
city: Austin
country: United States
facility: Austin Clinical Trial Partners
state: Texas
city: Austin
country: United States
facility: BioBehavioral Research of Austin
state: Texas
city: Draper
country: United States
facility: Cedar Clinical Research
state: Utah
city: Bennington
country: United States
facility: Memory Clinic Inc.
state: Vermont
city: Seattle
country: United States
facility: Seattle Neuropsychiatric Treatment Center
state: Washington
Study officials:
References: