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Trial Outcomes & Findings for Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial (NCT NCT05200936)

NCT ID: NCT05200936

Last Updated: 2025-04-13

Results Overview

The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-04-13

Participant Flow

A total of 74 potential participants were screened and 21 were excluded.

Participant milestones

Participant milestones
Measure
Arm 2- MM-120
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Overall Study
STARTED
27
26
Overall Study
COMPLETED
23
23
Overall Study
NOT COMPLETED
4
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm 2- MM-120
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Overall Study
Withdrawal by Subject
2
2
Overall Study
Lost to Follow-up
2
0
Overall Study
Pregnancy
0
1

Baseline Characteristics

Baseline values from subjects not included in Primary efficacy analysis were excluded from this calculation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm 2- MM-120
n=27 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
n=26 Participants
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Total
n=53 Participants
Total of all reporting groups
Age, Continuous
40.3 years
STANDARD_DEVIATION 12.8 • n=27 Participants
33.1 years
STANDARD_DEVIATION 11.0 • n=26 Participants
36.7 years
STANDARD_DEVIATION 12.4 • n=53 Participants
Sex: Female, Male
Female
13 Participants
n=27 Participants
9 Participants
n=26 Participants
22 Participants
n=53 Participants
Sex: Female, Male
Male
14 Participants
n=27 Participants
17 Participants
n=26 Participants
31 Participants
n=53 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=53 Participants
Race (NIH/OMB)
Asian
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=53 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=53 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=53 Participants
Race (NIH/OMB)
White
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=53 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=53 Participants
Race (NIH/OMB)
Unknown or Not Reported
27 Participants
n=27 Participants
26 Participants
n=26 Participants
53 Participants
n=53 Participants
Region of Enrollment
Netherlands
2 participants
n=27 Participants
1 participants
n=26 Participants
3 participants
n=53 Participants
Region of Enrollment
Switzerland
25 participants
n=27 Participants
25 participants
n=26 Participants
50 participants
n=53 Participants
Baseline ADHD investigator symptom rating scale (AISRS)
37.4 units on a scale
STANDARD_DEVIATION 6.11 • n=23 Participants • Baseline values from subjects not included in Primary efficacy analysis were excluded from this calculation
37.3 units on a scale
STANDARD_DEVIATION 5.24 • n=23 Participants • Baseline values from subjects not included in Primary efficacy analysis were excluded from this calculation
37.4 units on a scale
STANDARD_DEVIATION 5.69 • n=46 Participants • Baseline values from subjects not included in Primary efficacy analysis were excluded from this calculation

PRIMARY outcome

Timeframe: 6 weeks

Population: Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized

The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=23 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
n=23 Participants
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms
Baseline
37.4 units on a scale
Standard Deviation 6.11
37.3 units on a scale
Standard Deviation 5.24
Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms
Week 6
29.6 units on a scale
Standard Deviation 8.27
29.0 units on a scale
Standard Deviation 8.47

SECONDARY outcome

Timeframe: Week 2

Population: Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized

The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=26 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
n=26 Participants
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms
Baseline
37.5 units on a scale
Standard Deviation 5.76
36.9 units on a scale
Standard Deviation 5.10
Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms
Week 2
34.2 units on a scale
Standard Deviation 6.49
32.1 units on a scale
Standard Deviation 4.96

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 6, Week 10

Population: Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized

The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness.

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=27 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
n=26 Participants
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S)
Baseline to Week 2
8 Participants
11 Participants
Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S)
Baseline to Week 6
16 Participants
15 Participants
Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S)
Baseline to Week 10
17 Participants
12 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 6

Population: Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized

The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness.

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=27 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
n=26 Participants
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Change From Baseline in in Clinical Global Impressions Scale (CGI-S)
Baseline for Week 2
4.9 units on a scale
Standard Deviation 0.71
4.7 units on a scale
Standard Deviation 0.62
Change From Baseline in in Clinical Global Impressions Scale (CGI-S)
Week 2
4.6 units on a scale
Standard Deviation 0.70
4.3 units on a scale
Standard Deviation 0.53
Change From Baseline in in Clinical Global Impressions Scale (CGI-S)
Baseline for Week 6
4.9 units on a scale
Standard Deviation 0.73
4.8 units on a scale
Standard Deviation 0.60
Change From Baseline in in Clinical Global Impressions Scale (CGI-S)
Week 6
4.0 units on a scale
Standard Deviation 0.88
3.8 units on a scale
Standard Deviation 0.85

SECONDARY outcome

Timeframe: 6 weeks

Population: Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized

The Adult Attention-Deficit/Hyperactivity Disorder Self-Reporting Rating Scale (ASRS) is composed of 18 questions, and uses a scale that ranges from 0-4 based on the individuals mark in either the "never, rarely, sometimes, often, very often" column for a possible total score of 72. A higher score corresponds to a worse severity of ADHD.

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=27 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
n=26 Participants
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)
Baseline for Week 2
48.0 units on a scale
Standard Deviation 7.01
43.9 units on a scale
Standard Deviation 7.33
Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)
Week 2
40.2 units on a scale
Standard Deviation 9.26
36.7 units on a scale
Standard Deviation 9.38
Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)
Baseline for Week 4
48.6 units on a scale
Standard Deviation 7.67
44.6 units on a scale
Standard Deviation 7.61
Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)
Week 4
35.2 units on a scale
Standard Deviation 8.14
34.9 units on a scale
Standard Deviation 9.29
Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)
Baseline for Week 6 (Day 36)
48.4 units on a scale
Standard Deviation 7.10
44.2 units on a scale
Standard Deviation 7.72
Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)
Week 6 (Day 36)
36.0 units on a scale
Standard Deviation 9.99
33.1 units on a scale
Standard Deviation 11.70
Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)
Baseline to Week 6 (Day 40)
49.6 units on a scale
Standard Deviation 6.96
44.0 units on a scale
Standard Deviation 7.86
Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)
Week 6 (Day 40)
31.0 units on a scale
Standard Deviation 9.18
31.7 units on a scale
Standard Deviation 12.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized

The Connors' Adult ADHD Rating Scale (CAARS) Self-Report Long Form is a 66-item measure of ADHD symptom. Responses are scored on a 4-point scale, where 0 = not at all, 1 = just a little, 2 = pretty much, and 3 = very much. Item scores are summed to three main scores which are then transformed using population-derived age- and sex-adjusted norm values to a T-score. A T-score \< 60 indicates no ADHD. A T-score of 60-64 indicates borderline ADHD. A T-score of \> 64 indicates ADHD.

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=27 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
n=26 Participants
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS)
Change from baseline to Week 2
-4.0 units on a scale
Standard Deviation 5.79
-2 units on a scale
Standard Deviation 3.29
Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS)
Change from baseline to Week 4
-6.9 units on a scale
Standard Deviation 5.36
-3.6 units on a scale
Standard Deviation 4.4
Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS)
Change from Baseline to Week 6 (Day 36)
-5.6 units on a scale
Standard Deviation 6
-4.6 units on a scale
Standard Deviation 5.1
Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS)
Change from Baseline to Week 6 (Day 40)
-6.3 units on a scale
Standard Deviation 5.82
-4.3 units on a scale
Standard Deviation 5.98

SECONDARY outcome

Timeframe: 6 weeks

Population: Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized.

The 5 dimensions of altered states of consciousness (5D-ASC) scale is a visual analog scale (VAS) consisting of 94 items each scored on a 0-100mm VAS extrapolated to 100% scale for quantitative evaluation. These 94 items are categorized into five dimensions: oceanic boundlessness (min:0, max:2700), anxious ego dissolution (min:0, max:2100), visionary destructuralization (min:0, max:1800), auditory alterations (min:0, max:1600), and vigilance reduction (min:0, max:1200). The total score is the sum of all questions and can range from 0 to 9400. Higher scores = more alteration in state of consciousness.

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=27 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
n=26 Participants
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W6 Visionary destructuralization
199.7 units on a scale
Interval 86.9 to 312.5
32.9 units on a scale
Interval 6.4 to 59.4
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W1D1 Oceanic boundlessness
479.6 units on a scale
Interval 277.3 to 681.9
161.3 units on a scale
Interval 26.2 to 296.4
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W1D1 Anxious ego dissolution
103.6 units on a scale
Interval 35.5 to 171.6
19.0 units on a scale
Interval 5.9 to 32.2
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W1D1 Visionary destructuralization
233.4 units on a scale
Interval 135.6 to 331.2
94.8 units on a scale
Interval 18.6 to 171.0
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W1D1 Auditory alterations
71.0 units on a scale
Interval 12.2 to 129.7
32.7 units on a scale
Interval 1.6 to 63.8
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W1D1 Vigilance reduction
288.5 units on a scale
Interval 198.0 to 379.0
155.2 units on a scale
Interval 79.3 to 231.1
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W1D1 Total score
1176.0 units on a scale
Interval 781.4 to 1570.6
463.0 units on a scale
Interval 166.9 to 759.1
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W6 Oceanic boundlessness
403.3 units on a scale
Interval 194.3 to 612.4
70.2 units on a scale
Interval 16.0 to 124.4
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W6 Anxious ego dissolution
41.0 units on a scale
Interval -0.6 to 82.7
4.2 units on a scale
Interval -0.4 to 8.7
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W6 Auditory alterations
18.4 units on a scale
Interval 0.2 to 36.7
4.2 units on a scale
Interval 0.0 to 8.4
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W6 Vigilance reduction
90.3 units on a scale
Interval 52.2 to 128.5
20.0 units on a scale
Interval 6.9 to 33.1
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
W6 Total scores
752.9 units on a scale
Interval 387.2 to 1118.6
131.4 units on a scale
Interval 50.0 to 212.8

SECONDARY outcome

Timeframe: 6 weeks

Population: Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized.

The Mystical Experience Questionnaire 30 item (MEQ30) is a 30-item questionnaire rated on a six-point scale. The scale has been used to assess mystical experiences in studies using psilocybin and LSD. Higher scores = greater mystical experiences. The total score is expressed as a percentage of the maximum possible score (0 to 100%).

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=27 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
n=26 Participants
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Mystical Experience Questionnaire 30 Items (MEQ30)
Week 1 Day 1
22.37 percentage of maximum possible score
Interval 14.57 to 30.17
10.40 percentage of maximum possible score
Interval 3.97 to 16.84
Mystical Experience Questionnaire 30 Items (MEQ30)
Week 6
20.50 percentage of maximum possible score
Interval 11.94 to 29.06
5.20 percentage of maximum possible score
Interval 1.4 to 9.01

SECONDARY outcome

Timeframe: 6 hours

Population: Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized.

A series of single item visual Analog Scales (VAS) are used repeatedly 0 -6 hours after drug administration: The following 9 items were used in VAS (0-100 mm): "any drug effect", "good drug effect", bad drug effect", "drug liking", "fear", nausea", "alteration of vision", "alteration of sense of time", and "the boundaries between myself and my surroundings seem to blur". VAS scores range from 0 = no effect to 100 = strong effect. The scores for each item are extrapolated to a 100% scale and presented for each time point of assessment.

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=27 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
n=26 Participants
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Summary of Drug Effects Visual Analog Scale (VAS)
0h Any drug effect
0 percentage of maximum possible score
Interval 0.0 to 0.0
0 percentage of maximum possible score
Interval 0.0 to 0.0
Summary of Drug Effects Visual Analog Scale (VAS)
0h Drug liking
37.1 percentage of maximum possible score
Interval 0.0 to 55.0
44.9 percentage of maximum possible score
Interval 0.0 to 52.0
Summary of Drug Effects Visual Analog Scale (VAS)
0h Fear
2.7 percentage of maximum possible score
Interval 0.0 to 36.0
1.4 percentage of maximum possible score
Interval 0.0 to 23.0
Summary of Drug Effects Visual Analog Scale (VAS)
0h Nausea
1.1 percentage of maximum possible score
Interval 0.0 to 30.0
0 percentage of maximum possible score
Interval 0.0 to 0.0
Summary of Drug Effects Visual Analog Scale (VAS)
0h Alteration of vision
0 percentage of maximum possible score
Interval 0.0 to 0.0
0 percentage of maximum possible score
Interval 0.0 to 0.0
Summary of Drug Effects Visual Analog Scale (VAS)
0h Alteration of sense of time
0 percentage of maximum possible score
Interval 0.0 to 0.0
0 percentage of maximum possible score
Interval 0.0 to 0.0
Summary of Drug Effects Visual Analog Scale (VAS)
0h Boundaries blur
0 percentage of maximum possible score
Interval 0.0 to 0.0
0 percentage of maximum possible score
Interval 0.0 to 0.0
Summary of Drug Effects Visual Analog Scale (VAS)
0.5h Any drug effect
8.9 percentage of maximum possible score
Interval 0.0 to 78.0
11.3 percentage of maximum possible score
Interval 0.0 to 75.0
Summary of Drug Effects Visual Analog Scale (VAS)
0.5h Drug liking
44.4 percentage of maximum possible score
Interval 0.0 to 78.0
48.1 percentage of maximum possible score
Interval 0.0 to 83.0
Summary of Drug Effects Visual Analog Scale (VAS)
0.5h Fear
2.0 percentage of maximum possible score
Interval 0.0 to 54.0
2.2 percentage of maximum possible score
Interval 0.0 to 48.0
Summary of Drug Effects Visual Analog Scale (VAS)
0.5h Nausea
2.0 percentage of maximum possible score
Interval 0.0 to 53.0
0.2 percentage of maximum possible score
Interval 0.0 to 3.0
Summary of Drug Effects Visual Analog Scale (VAS)
0.5h Alteration of vision
3.5 percentage of maximum possible score
Interval 0.0 to 54.0
7.4 percentage of maximum possible score
Interval 0.0 to 81.0
Summary of Drug Effects Visual Analog Scale (VAS)
0.5h Alteration of sense of time
2.5 percentage of maximum possible score
Interval 0.0 to 41.0
3.2 percentage of maximum possible score
Interval 0.0 to 35.0
Summary of Drug Effects Visual Analog Scale (VAS)
0.5h Boundaries blur
3.0 percentage of maximum possible score
Interval 0.0 to 71.0
0.8 percentage of maximum possible score
Interval 0.0 to 12.0
Summary of Drug Effects Visual Analog Scale (VAS)
1h Any drug effect
24.1 percentage of maximum possible score
Interval 0.0 to 100.0
12.7 percentage of maximum possible score
Interval 0.0 to 64.0
Summary of Drug Effects Visual Analog Scale (VAS)
1h Drug liking
49.7 percentage of maximum possible score
Interval 0.0 to 97.0
51.8 percentage of maximum possible score
Interval 2.0 to 97.0
Summary of Drug Effects Visual Analog Scale (VAS)
1h Fear
1.4 percentage of maximum possible score
Interval 0.0 to 32.0
0.1 percentage of maximum possible score
Interval 0.0 to 2.0
Summary of Drug Effects Visual Analog Scale (VAS)
1h Nausea
2.7 percentage of maximum possible score
Interval 0.0 to 37.0
1.0 percentage of maximum possible score
Interval 0.0 to 23.0
Summary of Drug Effects Visual Analog Scale (VAS)
1h Alteration of vision
4.0 percentage of maximum possible score
Interval 0.0 to 56.0
6.9 percentage of maximum possible score
Interval 0.0 to 72.0
Summary of Drug Effects Visual Analog Scale (VAS)
1h Alteration of sense of time
8.1 percentage of maximum possible score
Interval 0.0 to 73.0
6.3 percentage of maximum possible score
Interval 0.0 to 68.0
Summary of Drug Effects Visual Analog Scale (VAS)
1h Boundaries blur
6.0 percentage of maximum possible score
Interval 0.0 to 87.0
1.5 percentage of maximum possible score
Interval 0.0 to 24.0
Summary of Drug Effects Visual Analog Scale (VAS)
2h Any drug effect
38.1 percentage of maximum possible score
Interval 0.0 to 97.0
12.8 percentage of maximum possible score
Interval 0.0 to 72.0
Summary of Drug Effects Visual Analog Scale (VAS)
2h Drug liking
57.3 percentage of maximum possible score
Interval 0.0 to 100.0
53.3 percentage of maximum possible score
Interval 3.0 to 100.0
Summary of Drug Effects Visual Analog Scale (VAS)
2h Fear
4.1 percentage of maximum possible score
Interval 0.0 to 68.0
0.1 percentage of maximum possible score
Interval 0.0 to 2.0
Summary of Drug Effects Visual Analog Scale (VAS)
2h Nausea
8.2 percentage of maximum possible score
Interval 0.0 to 60.0
0.1 percentage of maximum possible score
Interval 0.0 to 2.0
Summary of Drug Effects Visual Analog Scale (VAS)
2h Alteration of vision
13.0 percentage of maximum possible score
Interval 0.0 to 84.0
6.2 percentage of maximum possible score
Interval 0.0 to 88.0
Summary of Drug Effects Visual Analog Scale (VAS)
2h Alteration of sense of time
13.5 percentage of maximum possible score
Interval 0.0 to 78.0
4.4 percentage of maximum possible score
Interval 0.0 to 53.0
Summary of Drug Effects Visual Analog Scale (VAS)
2h Boundaries blur
12.3 percentage of maximum possible score
Interval 0.0 to 83.0
1.3 percentage of maximum possible score
Interval 0.0 to 14.0
Summary of Drug Effects Visual Analog Scale (VAS)
3h Any drug effect
44.3 percentage of maximum possible score
Interval 0.0 to 97.0
11.1 percentage of maximum possible score
Interval 0.0 to 65.0
Summary of Drug Effects Visual Analog Scale (VAS)
3h Drug liking
61.6 percentage of maximum possible score
Interval 0.0 to 100.0
53.1 percentage of maximum possible score
Interval 3.0 to 96.0
Summary of Drug Effects Visual Analog Scale (VAS)
3h Fear
2.9 percentage of maximum possible score
Interval 0.0 to 54.0
0.2 percentage of maximum possible score
Interval 0.0 to 2.0
Summary of Drug Effects Visual Analog Scale (VAS)
3h Nausea
8.0 percentage of maximum possible score
Interval 0.0 to 56.0
0.2 percentage of maximum possible score
Interval 0.0 to 3.0
Summary of Drug Effects Visual Analog Scale (VAS)
3h Alteration of vision
13.9 percentage of maximum possible score
Interval 0.0 to 84.0
6.5 percentage of maximum possible score
Interval 0.0 to 76.0
Summary of Drug Effects Visual Analog Scale (VAS)
3h Alteration of sense of time
12.3 percentage of maximum possible score
Interval 0.0 to 89.0
4.9 percentage of maximum possible score
Interval 0.0 to 74.0
Summary of Drug Effects Visual Analog Scale (VAS)
3h Boundaries blur
12.7 percentage of maximum possible score
Interval 0.0 to 88.0
1.4 percentage of maximum possible score
Interval 0.0 to 31.0
Summary of Drug Effects Visual Analog Scale (VAS)
4h Any drug effect
38.5 percentage of maximum possible score
Interval 0.0 to 97.0
15.1 percentage of maximum possible score
Interval 0.0 to 100.0
Summary of Drug Effects Visual Analog Scale (VAS)
4h Drug liking
60.7 percentage of maximum possible score
Interval 0.0 to 100.0
48.0 percentage of maximum possible score
Interval 2.0 to 100.0
Summary of Drug Effects Visual Analog Scale (VAS)
4h Fear
2.7 percentage of maximum possible score
Interval 0.0 to 50.0
0.1 percentage of maximum possible score
Interval 0.0 to 2.0
Summary of Drug Effects Visual Analog Scale (VAS)
4h Nausea
6.9 percentage of maximum possible score
Interval 0.0 to 65.0
0.1 percentage of maximum possible score
Interval 0.0 to 2.0
Summary of Drug Effects Visual Analog Scale (VAS)
4h Alteration of vision
12.4 percentage of maximum possible score
Interval 0.0 to 86.0
3.2 percentage of maximum possible score
Interval 0.0 to 37.0
Summary of Drug Effects Visual Analog Scale (VAS)
4h Alteration of sense of time
12.1 percentage of maximum possible score
Interval 0.0 to 92.0
7.0 percentage of maximum possible score
Interval 0.0 to 57.0
Summary of Drug Effects Visual Analog Scale (VAS)
4h Boundaries blur
6.9 percentage of maximum possible score
Interval 0.0 to 69.0
0.2 percentage of maximum possible score
Interval 0.0 to 2.0
Summary of Drug Effects Visual Analog Scale (VAS)
6h Any drug effect
16.7 percentage of maximum possible score
Interval 0.0 to 75.0
9.6 percentage of maximum possible score
Interval 0.0 to 72.0
Summary of Drug Effects Visual Analog Scale (VAS)
6h Drug liking
54.8 percentage of maximum possible score
Interval 0.0 to 100.0
49.6 percentage of maximum possible score
Interval 0.0 to 100.0
Summary of Drug Effects Visual Analog Scale (VAS)
6h Fear
2.3 percentage of maximum possible score
Interval 0.0 to 52.0
2.1 percentage of maximum possible score
Interval 0.0 to 48.0
Summary of Drug Effects Visual Analog Scale (VAS)
6h Nausea
3.6 percentage of maximum possible score
Interval 0.0 to 52.0
0.2 percentage of maximum possible score
Interval 0.0 to 4.0
Summary of Drug Effects Visual Analog Scale (VAS)
6h Alteration of vision
4.1 percentage of maximum possible score
Interval 0.0 to 59.0
5.8 percentage of maximum possible score
Interval 0.0 to 59.0
Summary of Drug Effects Visual Analog Scale (VAS)
6h Alteration of sense of time
6.3 percentage of maximum possible score
Interval 0.0 to 69.0
3.0 percentage of maximum possible score
Interval 0.0 to 55.0
Summary of Drug Effects Visual Analog Scale (VAS)
6h Boundaries blur
4.1 percentage of maximum possible score
Interval 0.0 to 61.0
0.1 percentage of maximum possible score
Interval 0.0 to 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5, 1, 2, 3, 4, 6 hours post-dose

Population: Pharmacokinetic Set (PKS): All subjects in the randomized set (RAN) who received a dose of MM120 and had at least 1 postdose PK measurement without important protocol deviations thought to significantly affect the PK of the drug. A strategy for dealing with data affected by protocol violations and deviations was to be agreed to by the Sponsor, monitor, and pharmacokineticist, prior to clean file and code break. Subjects were analyzed according to the treatment they actually received.

Maximum Plasma Concentration \[Cmax\] of MM-120 in the blood at Week 1 Day 1

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=24 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Pharmacokinetic Outcomes
Pre-dose (0 hours)
0 ng/mL
Standard Deviation 0
—
Pharmacokinetic Outcomes
0.5hours
0.3250 ng/mL
Standard Deviation 0.16534
—
Pharmacokinetic Outcomes
1hour
0.4410 ng/mL
Standard Deviation 0.15686
—
Pharmacokinetic Outcomes
2hours
0.4270 ng/mL
Standard Deviation 0.12832
—
Pharmacokinetic Outcomes
3hours
0.3591 ng/mL
Standard Deviation 0.12493
—
Pharmacokinetic Outcomes
4hours
0.3066 ng/mL
Standard Deviation 0.10851
—
Pharmacokinetic Outcomes
6hours
0.2117 ng/mL
Standard Deviation 0.09361
—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5, 1, 2, 3, 4, 6 hours post-dose

Population: Pharmacokinetic Set (PKS): All subjects in the randomized set (RAN) who received a dose of MM120 and had at least 1 postdose PK measurement without important protocol deviations thought to significantly affect the PK of the drug. A strategy for dealing with data affected by protocol violations and deviations was to be agreed to by the Sponsor, monitor, and pharmacokineticist, prior to clean file and code break. Subjects were analyzed according to the treatment they actually received.

Maximum concentration (Cmax)

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=24 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Pharmacokinetic Parameters (Cmax)
0.4811 ng/mL
Standard Deviation 0.14279
—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5, 1, 2, 3, 4, 6 hours post-dose

Population: Pharmacokinetic Set (PKS): All subjects in the randomized set (RAN) who received a dose of MM120 and had at least 1 postdose PK measurement without important protocol deviations thought to significantly affect the PK of the drug. A strategy for dealing with data affected by protocol violations and deviations was to be agreed to by the Sponsor, monitor, and pharmacokineticist, prior to clean file and code break. Subjects were analyzed according to the treatment they actually received.

Time to maximum concentration (Tmax), half life (t1/2)

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=24 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Pharmacokinetic Parameters (Tmax and t1/2)
Tmax
1.46 hours
Standard Deviation 0.706
—
Pharmacokinetic Parameters (Tmax and t1/2)
t1/2
3.8187 hours
Standard Deviation 1.27269
—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0.5, 1, 2, 3, 4, 6 hours post-dose

Population: Pharmacokinetic Set (PKS): All subjects in the randomized set (RAN) who received a dose of MM120 and had at least 1 postdose PK measurement without important protocol deviations thought to significantly affect the PK of the drug. A strategy for dealing with data affected by protocol violations and deviations was to be agreed to by the Sponsor, monitor, and pharmacokineticist, prior to clean file and code break. Subjects were analyzed according to the treatment they actually received.

Area under the concentration curve from time 0 to infinity (AUC0-inf), Area under the concentration curve from time 0 to 6 hour (AUC0-6h)

Outcome measures

Outcome measures
Measure
Arm 2- MM-120
n=24 Participants
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Pharmacokinetic Parameters (AUC0-inf and AUC0-6h)
AUC0-inf
3.2450 ng*h/mL
Standard Deviation 1.58494
—
Pharmacokinetic Parameters (AUC0-inf and AUC0-6h)
AUC0-6hr
1.9411 ng*h/mL
Standard Deviation 0.63490
—

Adverse Events

Arm 2- MM-120

Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths

Arm 1- Placebo

Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Arm 2- MM-120
n=27 participants at risk
A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks. MM-120: MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.
Arm 1- Placebo
n=26 participants at risk
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value.
Gastrointestinal disorders
Vomiting
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Nervous system disorders
Headache
48.1%
13/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
34.6%
9/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Nervous system disorders
Disturbance in Attention
7.4%
2/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
7.7%
2/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Nervous system disorders
Akathisia
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Nervous system disorders
Dizziness postural
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Nervous system disorders
Restless leg syndrome
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Nervous system disorders
Somnolence
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Psychiatric disorders
Illusion
14.8%
4/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Psychiatric disorders
Insomnia
11.1%
3/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Psychiatric disorders
Apathy
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
7.7%
2/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Psychiatric disorders
Euphoric mood
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Psychiatric disorders
Flashbacks
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Psychiatric disorders
Hypersomnia
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Psychiatric disorders
Sleep disorder
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Gastrointestinal disorders
Nausea
18.5%
5/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Gastrointestinal disorders
Abdominal pain
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
7.7%
2/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Gastrointestinal disorders
Abdominal pain upper
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Gastrointestinal disorders
Diarrhoea
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Gastrointestinal disorders
Flatulence
7.4%
2/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Infections and infestations
Nasopharyngitis
11.1%
3/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
19.2%
5/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Infections and infestations
Urinary tract infection
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
General disorders
Fatigue
14.8%
4/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
General disorders
Feeling abnormal
7.4%
2/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
General disorders
Swelling
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Investigations
Full blood count abnormal
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Investigations
Heart rate increased
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Investigations
Pregnancy test positive
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Investigations
SARS-CoV-2 test positive
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Investigations
Urine cannabinoids increased
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Injury, poisoning and procedural complications
Contusion
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Injury, poisoning and procedural complications
Ankle fracture
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Injury, poisoning and procedural complications
Palate injury
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Injury, poisoning and procedural complications
Wound
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Cardiac disorders
Palpitations
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Cardiac disorders
Syncope
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Musculoskeletal and connective tissue disorders
Back pain
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Musculoskeletal and connective tissue disorders
Muscle tightness
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Respiratory, thoracic and mediastinal disorders
Epistaxis
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Respiratory, thoracic and mediastinal disorders
Throat tightness
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Vascular disorders
Hot flush
7.4%
2/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Vascular disorders
Hypertension
7.4%
2/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Skin and subcutaneous tissue disorders
Hyperhidrosis
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Skin and subcutaneous tissue disorders
Rash
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Blood and lymphatic system disorders
Anaemia
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Ear and labyrinth disorders
Ear pain
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Eye disorders
Vision blurred
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Hepatobiliary disorders
Liver disorder
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Metabolism and nutrition disorders
Hypophosphataemia
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Renal and urinary disorders
Urethritis noninfective
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Reproductive system and breast disorders
Premenstrual pain
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Social circumstances
High risk sexual behaviour
3.7%
1/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
0.00%
0/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
Surgical and medical procedures
Tooth extraction
0.00%
0/27 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
3.8%
1/26 • From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.

Additional Information

Medical Affairs

Mind Medicine Inc

Phone: 1-332-245-4732

Results disclosure agreements

  • Principal investigator is a sponsor employee 1. Sponsor has at least 30-60 days to review a proposed publication before submission for purposes of requesting the removal of Sponsor's confidential information. 2. PI's will not publish or disclosure their single-site data prior to a multi-center publication of the aggregate study data, unless Sponsor does not publish a multi-center publication within 12 months following conclusion of the overall study.
  • Publication restrictions are in place

Restriction type: OTHER