Clinical trial NCT05407064: A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
Official title: A Phase 2, Multi-center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Study to Assess the Effect of Four Doses of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety Generalized
Lead sponsor: Mind Medicine, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 198
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: This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM-120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Detailed description: The study will enroll approximately 200 male and female subjects 18 years to \< 75 years of age who meet DSM-5 criteria for GAD and have a minimum HAM-A Total Score of 20. Subjects on contraindicated concomitant medications, supplements or other therapeutics at Screening (Visit 1) will undergo a medication taper prior to advancing to Baseline (Visit 2).

Eligibility criteria: Inclusion Criteria:

* Bodyweight of ≥ 50 kg
* Body mass index \[BMI\] ≥ 18 to ≤ 38 mg/kg2
* Diagnosis of DSM-5 generalized anxiety disorder
* Acceptable overall medical condition to be safely enrolled into and to complete the study
* Ability to swallow capsules
* Ability to provide informed consent

Exclusion Criteria:

* Women of childbearing potential (WOCBP) (i.e., physiologically capable of becoming pregnant) who are unwilling or unable to use a highly effective method of contraception for the duration of the study, OR Men physiologically capable of fathering a child who are sexually active with WOCBP but are unwilling or unable to use barrier contraception (e.g., condom with or without spermicidal cream or jelly) for the duration of the study
* Women who are currently pregnant or breastfeeding or plan to become pregnant or breastfeed during the study
* Men who plan to donate sperm during the study
* Prior history (lifetime diagnosis) with a lifetime diagnosis of schizophrenia spectrum, or other psychotic disorders or bipolar disorder
* Has a significant risk of suicide attempt based upon medical history or has active suicidal ideation
* Unwillingness or inability to discontinue prohibited concomitant medications, supplements or other therapeutics (prescription or over-the-counter)

Primary outcomes:
measure: Dose Response
timeFrame: 4 weeks
Secondary outcomes:
measure: Dose Response
timeFrame: 8 weeks
measure: Change From Baseline in HAM-A Total Score
timeFrame: 4 weeks
measure: Change From Baseline in HAM-A Total Scores
timeFrame: 8 weeks
measure: Change From Baseline in HAM-A Total Scores
timeFrame: 12 weeks
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores
timeFrame: Week 1
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores
timeFrame: Week 2
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores
timeFrame: Week 4
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores
timeFrame: Week 8
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores
timeFrame: End of Study (Week 12)
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores
timeFrame: Week 1
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores
timeFrame: Week 2
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores
timeFrame: Week 4
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores
timeFrame: Week 8
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Scores
timeFrame: End of Study (12 weeks)
measure: Mean Clinical Global Impression - Improvement (CGI-I) Total Scores
timeFrame: Week 1
measure: Mean Clinical Global Impression - Improvement (CGI-I) Total Scores
timeFrame: Week 2
measure: Mean Clinical Global Impression - Improvement (CGI-I) Total Scores
timeFrame: Week 4
measure: Mean Clinical Global Impression - Improvement (CGI-I) Total Scores
timeFrame: Week 8
measure: Mean Clinical Global Impression - Improvement (CGI-I) Total Scores
timeFrame: End of Study (Week 12)
measure: Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores
timeFrame: Week 1
measure: Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores
timeFrame: Week 2
measure: Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores
timeFrame: Week 4
measure: Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores
timeFrame: Week 8
measure: Change From Baseline in Patient Global Impression - Severity (PGI-S) Total Scores
timeFrame: End of study (Week 12)
measure: Mean Patient Global Impression - Change (PGI-C) Total Scores
timeFrame: Week 1
measure: Mean Patient Global Impression - Change (PGI-C) Total Scores
timeFrame: Week 2
measure: Mean Patient Global Impression - Change (PGI-C) Total Scores
timeFrame: Week 4
measure: Mean Patient Global Impression - Change (PGI-C) Total Scores
timeFrame: Week 8
measure: Change From Baseline in Patient Global Impression - Change (PGI-C) Total Scores
timeFrame: End of Study (Week 12)
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Scores
timeFrame: Week 1
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Scores
timeFrame: Week 2
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Scores
timeFrame: Week 4
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Scores
timeFrame: Week 8
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Scores
timeFrame: End of Study (Week 12)
measure: Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)
timeFrame: Week 1
measure: Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)
timeFrame: Week 2
measure: Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)
timeFrame: Week 4
measure: Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)
timeFrame: Week 8
measure: Improved Quality of Life as Measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS)
timeFrame: End of Study (12 weeks)
measure: Improved Sleep as Measured by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 4
measure: Improved Sleep as Measured by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 8
measure: Improved Sleep as Measured by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: End of Study (Week 12)
measure: Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females
timeFrame: Week 1
measure: Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females
timeFrame: Week 2
measure: Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females
timeFrame: Week 4
measure: Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females
timeFrame: Week 8
measure: Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Females
timeFrame: End of Study (Week 12)
measure: Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males
timeFrame: Week 1
measure: Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males
timeFrame: Week 2
measure: Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males
timeFrame: Week 4
measure: Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males
timeFrame: Week 8
measure: Improved Sexual Functioning as Measured by Arizona Sexual Experiences Questionnaire (ASEX) - Males
timeFrame: End of Study (Week 12)
measure: Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 1
timeFrame: Week 1
measure: Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 2
timeFrame: Week 2
measure: Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 4
timeFrame: Week 4
measure: Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 8
timeFrame: Week 8
measure: Summary of Sexual Dysfunction Rates (ASEX), Females, to Week 12
timeFrame: End of Study (Week 12)
measure: Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 1
timeFrame: Week 1
measure: Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 2
timeFrame: Week 2
measure: Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 4
timeFrame: Week 4
measure: Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 8
timeFrame: Week 8
measure: Summary of Sexual Dysfunction Rates (ASEX), Males, to Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Irvine
country: United States
facility: Irvine Center for Clinical Research
state: California
city: La Jolla
country: United States
facility: Kadima Neuropsychiatry Institute
state: California
city: Santa Monica
country: United States
facility: Pacific Neuroscience Institute
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Fort Collins
country: United States
facility: Wholeness Center
state: Colorado
city: Lauderhill
country: United States
facility: Segal Trials
state: Florida
city: Orlando
country: United States
facility: CNS Healthcare - Orlando
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Chicago
country: United States
facility: Uptown Research
state: Illinois
city: Rockville
country: United States
facility: Sunstone Therapies
state: Maryland
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Princeton
country: United States
facility: GMI - Princeton Medical Institute
state: New Jersey
city: Cleveland
country: United States
facility: Lutheran Hospital - Cleveland Clinic
state: Ohio
city: Austin
country: United States
facility: BioBehavioral Research of Austin
state: Texas
city: Houston
country: United States
facility: University of Texas Health Houston
state: Texas
city: Draper
country: United States
facility: Cedar Clinical Research
state: Utah
city: Murray
country: United States
facility: Cedar Clinical Research - Murray
state: Utah
city: Woodstock
country: United States
facility: Woodstock Research Center
state: Vermont
Study officials:
References: