Trial Outcomes & Findings for A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD (NCT NCT04714359)
NCT ID: NCT04714359
Last Updated: 2025-06-06
Results Overview
The Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the symptoms of PTSD per DSM-5. Participants indicate how much distress they have experienced in the last 2 weeks due to symptoms such as "Repeated, disturbing memories, thoughts, or images of a stressful experience from the past," "Trouble remembering important parts of a stressful experience from the past," and "Feeling irritable or having angry outbursts" on a five-point Likert-type scale (0=Not at all to 4=Extremely). The total severity score can range from 0 to 80 and lower scores indicate less PTSD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
Baseline enrollment to approximately 18 weeks later (Visit 16 occurs 24 to 32 days after Experimental Session 3)
Results posted on
2025-06-06
Participant Flow
Participants who were randomized to the placebo arm in the two parent Phase 3 trials and who meet all other entry criteria will be eligible and invited to participate in this open-label safety extension study.
Participant milestones
| Measure |
MDMA-assisted Therapy
Three open-label sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl (80 or 120 mg) and optional supplemental dose of (40 or 60 mg), 1.5 to 2 hours later
Midomafetamine HCl: Three sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
|
|---|---|
|
Overall Study
STARTED
|
87
|
|
Overall Study
COMPLETED
|
78
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD
Baseline characteristics by cohort
| Measure |
MDMA-assisted Therapy
n=85 Participants
Three open-label sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl (80 or 120 mg) and optional supplemental dose of (40 or 60 mg), 1.5 to 2 hours later
Midomafetamine HCl: Three sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
|
|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 9.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Education
|
17.1 years
STANDARD_DEVIATION 2.34 • n=5 Participants
|
|
Trauma History
Veteran
|
14 Participants
n=5 Participants
|
|
Trauma History
Served in combat area
|
10 Participants
n=5 Participants
|
|
Trauma History
Multiple traumatic events
|
65 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline enrollment to approximately 18 weeks later (Visit 16 occurs 24 to 32 days after Experimental Session 3)Population: The primary outcome analysis (change from baseline) is based on the n=81 participants with PCL-5 data available at the primary outcome visit (Visit 16).
The Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the symptoms of PTSD per DSM-5. Participants indicate how much distress they have experienced in the last 2 weeks due to symptoms such as "Repeated, disturbing memories, thoughts, or images of a stressful experience from the past," "Trouble remembering important parts of a stressful experience from the past," and "Feeling irritable or having angry outbursts" on a five-point Likert-type scale (0=Not at all to 4=Extremely). The total severity score can range from 0 to 80 and lower scores indicate less PTSD symptoms.
Outcome measures
| Measure |
MDMA-assisted Therapy
n=81 Participants
Three open-label sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl (80 or 120 mg) and optional supplemental dose of (40 or 60 mg), 1.5 to 2 hours later
Midomafetamine HCl: Three sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
|
|---|---|
|
Change From Baseline to Visit 16 in PCL-5 Total Score
|
-14.92 score on a scale
Interval -18.05 to -11.79
|
SECONDARY outcome
Timeframe: Baseline enrollment to approximately 18 weeks later (Visit 16 occurs 24 to 32 days after Experimental Session 3)The SDS is a self-report assessment of functional impairment. The reporting period for the SDS refers to the past month. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), with higher scores indicating greater functional impairment.
Outcome measures
| Measure |
MDMA-assisted Therapy
n=71 Participants
Three open-label sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl (80 or 120 mg) and optional supplemental dose of (40 or 60 mg), 1.5 to 2 hours later
Midomafetamine HCl: Three sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
|
|---|---|
|
Change From Baseline to Visit 16 in Sheehan Disability Scale (SDS) Total Score
|
-4.10 score on a scale
Interval -5.95 to -2.25
|
Adverse Events
Pre-Treatment MDMA-Assisted Therapy
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
On Day 0, 1, or 2 MDMA-Assisted Therapy
Serious events: 0 serious events
Other events: 84 other events
Deaths: 0 deaths
Treatment-Emergent Adverse Events MDMA-Assisted Therapy
Serious events: 3 serious events
Other events: 84 other events
Deaths: 0 deaths
Follow-Up MDMA-Assisted Therapy
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-Treatment MDMA-Assisted Therapy
n=85 participants at risk
Adverse events that occur during the Preparatory Period prior to the first dose in the first MDMA-assisted therapy session.
|
On Day 0, 1, or 2 MDMA-Assisted Therapy
n=85 participants at risk
Adverse events that occur on the day of or within two days following each MDMA-assisted therapy session.
|
Treatment-Emergent Adverse Events MDMA-Assisted Therapy
n=85 participants at risk
Adverse events that occur during the Treatment Period from the first Experimental Session to the last Integrative Session.
|
Follow-Up MDMA-Assisted Therapy
n=85 participants at risk
Adverse Events that occurred after the last Integrative Session through follow-up.
|
|---|---|---|---|---|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Eye disorders
Retinal detachment
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
Other adverse events
| Measure |
Pre-Treatment MDMA-Assisted Therapy
n=85 participants at risk
Adverse events that occur during the Preparatory Period prior to the first dose in the first MDMA-assisted therapy session.
|
On Day 0, 1, or 2 MDMA-Assisted Therapy
n=85 participants at risk
Adverse events that occur on the day of or within two days following each MDMA-assisted therapy session.
|
Treatment-Emergent Adverse Events MDMA-Assisted Therapy
n=85 participants at risk
Adverse events that occur during the Treatment Period from the first Experimental Session to the last Integrative Session.
|
Follow-Up MDMA-Assisted Therapy
n=85 participants at risk
Adverse Events that occurred after the last Integrative Session through follow-up.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Eye disorders
Mydriasis
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
15.3%
13/85 • From baseline to end of follow up (approximately 18 weeks)
|
15.3%
13/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Eye disorders
Photophobia
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
3.5%
3/85 • From baseline to end of follow up (approximately 18 weeks)
|
4.7%
4/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Gastrointestinal disorders
Nausea
|
4.7%
4/85 • From baseline to end of follow up (approximately 18 weeks)
|
38.8%
33/85 • From baseline to end of follow up (approximately 18 weeks)
|
44.7%
38/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
18.8%
16/85 • From baseline to end of follow up (approximately 18 weeks)
|
18.8%
16/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
11.8%
10/85 • From baseline to end of follow up (approximately 18 weeks)
|
15.3%
13/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
4.7%
4/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
4.7%
4/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
General disorders
Fatigue
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
23.5%
20/85 • From baseline to end of follow up (approximately 18 weeks)
|
37.6%
32/85 • From baseline to end of follow up (approximately 18 weeks)
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
General disorders
Therapeutic response unexpected
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
27.1%
23/85 • From baseline to end of follow up (approximately 18 weeks)
|
28.2%
24/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
General disorders
Feeling hot
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
22.4%
19/85 • From baseline to end of follow up (approximately 18 weeks)
|
22.4%
19/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
General disorders
Feeling cold
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
18.8%
16/85 • From baseline to end of follow up (approximately 18 weeks)
|
18.8%
16/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
General disorders
Feeling abnormal
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
10.6%
9/85 • From baseline to end of follow up (approximately 18 weeks)
|
14.1%
12/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
14.1%
12/85 • From baseline to end of follow up (approximately 18 weeks)
|
14.1%
12/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
General disorders
Chills
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
11.8%
10/85 • From baseline to end of follow up (approximately 18 weeks)
|
12.9%
11/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
General disorders
Feeling of relaxation
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
9.4%
8/85 • From baseline to end of follow up (approximately 18 weeks)
|
9.4%
8/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
General disorders
Feeling jittery
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
General disorders
Gait disturbance
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
General disorders
Pain
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Infections and infestations
COVID-19
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
37.6%
32/85 • From baseline to end of follow up (approximately 18 weeks)
|
37.6%
32/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
58.8%
50/85 • From baseline to end of follow up (approximately 18 weeks)
|
58.8%
50/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.7%
4/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
14.1%
12/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
4.7%
4/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
4.7%
4/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.7%
4/85 • From baseline to end of follow up (approximately 18 weeks)
|
3.5%
3/85 • From baseline to end of follow up (approximately 18 weeks)
|
7.1%
6/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
4.7%
4/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Nervous system disorders
Headache
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
50.6%
43/85 • From baseline to end of follow up (approximately 18 weeks)
|
57.6%
49/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Nervous system disorders
Dizziness
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
22.4%
19/85 • From baseline to end of follow up (approximately 18 weeks)
|
23.5%
20/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
23.5%
20/85 • From baseline to end of follow up (approximately 18 weeks)
|
23.5%
20/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
20.0%
17/85 • From baseline to end of follow up (approximately 18 weeks)
|
21.2%
18/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Nervous system disorders
Tremor
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
10.6%
9/85 • From baseline to end of follow up (approximately 18 weeks)
|
11.8%
10/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Nervous system disorders
Disturbance in attention
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
7.1%
6/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Insomnia
|
4.7%
4/85 • From baseline to end of follow up (approximately 18 weeks)
|
29.4%
25/85 • From baseline to end of follow up (approximately 18 weeks)
|
38.8%
33/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Suicidal ideation
|
16.5%
14/85 • From baseline to end of follow up (approximately 18 weeks)
|
11.8%
10/85 • From baseline to end of follow up (approximately 18 weeks)
|
37.6%
32/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Anxiety
|
7.1%
6/85 • From baseline to end of follow up (approximately 18 weeks)
|
27.1%
23/85 • From baseline to end of follow up (approximately 18 weeks)
|
31.8%
27/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Depressed mood
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
16.5%
14/85 • From baseline to end of follow up (approximately 18 weeks)
|
23.5%
20/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
12.9%
11/85 • From baseline to end of follow up (approximately 18 weeks)
|
12.9%
11/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Restlessness
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
10.6%
9/85 • From baseline to end of follow up (approximately 18 weeks)
|
12.9%
11/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
11.8%
10/85 • From baseline to end of follow up (approximately 18 weeks)
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Anger
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
7.1%
6/85 • From baseline to end of follow up (approximately 18 weeks)
|
9.4%
8/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Depression
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
3.5%
3/85 • From baseline to end of follow up (approximately 18 weeks)
|
9.4%
8/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Nightmare
|
4.7%
4/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Panic attack
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Psychiatric disorders
Irritability
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
2.4%
2/85 • From baseline to end of follow up (approximately 18 weeks)
|
5.9%
5/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
8.2%
7/85 • From baseline to end of follow up (approximately 18 weeks)
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
1/85 • From baseline to end of follow up (approximately 18 weeks)
|
28.2%
24/85 • From baseline to end of follow up (approximately 18 weeks)
|
28.2%
24/85 • From baseline to end of follow up (approximately 18 weeks)
|
0.00%
0/85 • From baseline to end of follow up (approximately 18 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60