A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (VOYAGE)
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Other: PlaceboDrug: MM120 (LSD D-Tartrate)
- Registration Number
- NCT06741228
- Lead Sponsor
- Mind Medicine, Inc.
- 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 open-label extension (OLE) during which participants will be monitored and evaluated for potential retreatment with MM120 based on pre-specified safety and symptom severity criteria.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Male or female: must be between 18 (or the legal age of consent in the jurisdiction in which the study is taking place) and 74 years of age inclusive, at the time of signing the informed consent.
- Diagnosis of GAD per DSM-5.
- HAM-A Total Score ≥20.
-
Any psychiatric disorder (other than generalized anxiety disorder).
-
First degree relative with or lifetime history of a psychotic disorder or bipolar disorder.
-
Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine).
-
Any clinically significant unstable illness.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 - Placebo Placebo A substance that is designed to have no therapeutic value Arm 2 - 100µg MM120 (LSD D-Tartrate) MM120 (LSD D-Tartrate) A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
- Primary Outcome Measures
Name Time Method Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12 Baseline to Week 12 The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
- Secondary Outcome Measures
Name Time Method Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1 Week 8, Week 4, Week 2, and Week 1 The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period Baseline to Week 12 The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
HAM-A remission (total score ≤7) at each timepoint assessed during the 12-week double-blind treatment period Baseline to Week 12 The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period Day 2 to Week 12 The CGI-I scale is used to measure the clinician's assessment of how much the participant's illness has improved or worsened relative to Baseline (Visit 2). The CGI-I comprises one item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening.
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score Baseline to Week 12 The CGI-S scale assesses the clinician's impression of the participant's current severity of illness relative to the clinician's experience with patients who have the same diagnosis. The CGI-S comprises one item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness.
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score Baseline to Week 12 The PGI scale is the patient-reported outcome (PRO) counterpart to the CGI scale. The PGI-S comprises one participant-completed item with 5 possible ratings (1-5) where a higher score indicates more severe illness.
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -Montgomery-Åsberg Depression Rating Scale (MADRS) total score Baseline to Week 12 The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -Work Productivity and Activity Impairment Questionnaire (WPAI) Baseline to Week 12 The WPAI-SHP is a 6-item questionnaire, with a recall period of the past 7 days. The WPAI measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as impairment in unpaid activity because of the health problem under study.
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in -EuroQol-5 Dimensions - 5 Levels (EQ-5D-5L) Baseline to Week 12 The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-reported outcome measure used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS).
Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) total score at each timepoint assessed during the double-blind period Baseline to Week 12 The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.
Percent of men and women with normal and abnormal sexual functioning at each timepoint assessed during the double-blind period Baseline to Week 12 The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.
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 Day 1 to Week 52 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
Time to first treatment or lack of efficacy in the open-label period (Part B) Day 1 to Week 52 Measured as time from first dosing in the Double-blind period to participant meeting HAM-A criteria for re-dose or meeting criteria for lack of efficacy
Need for MM120 treatment as assessed by the average number of MM120 treatments during the study Day 1 to Week 52 Average number of treatments assessed from first dose in the double-blind period through completion of the open label extension.
HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 40-week open-label period 40 week open label period The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
HAM-A remission (total score ≤7) at each timepoint assessed during the 40-week open-label period 40 week open label period The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
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 Baseline to Week 52 The CGI-S scale assesses the clinician's impression of the participant's current severity of illness relative to the clinician's experience with patients who have the same diagnosis. The CGI-S comprises one item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness.
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 Baseline to Week 52 The PGI scale is the patient-reported outcome (PRO) counterpart to the CGI scale. The PGI-S comprises one participant-completed item with 5 possible ratings (1-5) where a higher score indicates more severe illness.
Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in MADRS total score Baseline to Week 52 The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.
Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in WPAI Baseline to Week 52 The WPAI-SHP is a 6-item questionnaire, with a recall period of the past 7 days. The WPAI measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as impairment in unpaid activity because of the health problem under study.
Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in EQ-5D-5L Baseline to Week 52 The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-reported outcome measure used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS).
CSFQ-14 total score at each timepoint assessed during the open-label period 40 week open label period The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.
Percent men and women with normal and abnormal sexual functioning at each timepoint assessed during the open-label period 40 week open label period The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.
Trial Locations
- Locations (27)
Lighthouse Psychiatry
🇺🇸Gilbert, Arizona, United States
Kadima Neuropsychiatry Institute
🇺🇸La Jolla, California, United States
UCSF Department of Neurology
🇺🇸San Francisco, California, United States
Pacific Neuroscience Institute
🇺🇸Santa Monica, California, United States
Mountain View
🇺🇸Denver, Colorado, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Jacksonville, Florida, United States
Accel Research Sites - Lakeland CRU
🇺🇸Lakeland, Florida, United States
Segal Trials
🇺🇸Lauderhill, Florida, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Kendall.chaves@accelclinical.com
🇺🇸Savannah, Georgia, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Hassman Research Institute
🇺🇸Marlton, New Jersey, United States
Spectrum Neuroscience and Treatment Institute
🇺🇸New York, New York, United States
New York State Psychiatric Institute (NYSPI)
🇺🇸New York, New York, United States
Cleveland Clinic Lutheran Hospital
🇺🇸Cleveland, Ohio, United States
Summit Headlands LLC
🇺🇸Portland, Oregon, United States
Scranton Medical Institute
🇺🇸Moosic, Pennsylvania, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Dell Medical School, University of Texas at Austin
🇺🇸Austin, Texas, United States
BioBehavioral Research of Austin
🇺🇸Austin, Texas, United States
Cedar Clinical Research
🇺🇸Draper, Utah, United States
Memory Clinic Inc.
🇺🇸Bennington, Vermont, United States
Seattle Neuropsychiatric Treatment Center
🇺🇸Seattle, Washington, United States