Trial Outcomes & Findings for Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder (NCT NCT01211405)
NCT ID: NCT01211405
Last Updated: 2025-06-05
Results Overview
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Baseline to one month after second experimental session
Results posted on
2025-06-05
Participant Flow
Participant milestones
| Measure |
Low Dose MDMA (30 mg)
Participants will receive 30 mg MDMA during each of two blinded experimental sessions.
Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later
Psychotherapy: Non-directive psychotherapy during each session
|
Medium Dose MDMA (75 mg)
Participants will receive 75 mg MDMA on each of two blinded experimental sessions
Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg
Psychotherapy: Non-directive psychotherapy during each session
|
Full Dose MDMA (125 mg)
Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.
Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.
Psychotherapy: Non-directive psychotherapy during each session
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
12
|
|
Overall Study
Completed Primary Endpoint
|
7
|
7
|
12
|
|
Overall Study
Completed Stage 1
|
6
|
6
|
12
|
|
Overall Study
Completed Stage 2
|
6
|
6
|
0
|
|
Overall Study
COMPLETED
|
6
|
7
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Low Dose MDMA (30 mg)
n=7 Participants
Participants will receive 30 mg MDMA during each of two blinded experimental sessions.
Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later
Psychotherapy: Non-directive psychotherapy during each session
|
Medium Dose MDMA (75 mg)
n=7 Participants
Participants will receive 75 mg MDMA on each of two blinded experimental sessions
Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg
Psychotherapy: Non-directive psychotherapy during each session
|
Full Dose MDMA (125 mg)
n=12 Participants
Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.
Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.
Psychotherapy: Non-directive psychotherapy during each session
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
40.7 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White/Caucasian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Latino/Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Native American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to one month after second experimental sessionPopulation: Intent-to-treat
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Outcome measures
| Measure |
Low Dose MDMA (30 mg)
n=7 Participants
Participants will receive 30 mg MDMA during each of two blinded experimental sessions.
Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later
Psychotherapy: Non-directive psychotherapy during each session
|
Medium Dose MDMA (75 mg)
n=7 Participants
Participants will receive 75 mg MDMA on each of two blinded experimental sessions
Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg
Psychotherapy: Non-directive psychotherapy during each session
|
Full Dose MDMA (125 mg)
n=12 Participants
Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.
Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.
Psychotherapy: Non-directive psychotherapy during each session
|
|---|---|---|---|
|
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to Primary Endpoint
|
-11.4 score on a scale
Standard Deviation 12.7
|
-58.3 score on a scale
Standard Deviation 9.8
|
-44.3 score on a scale
Standard Deviation 28.7
|
SECONDARY outcome
Timeframe: Baseline to one month after second experimental sessionPopulation: Intent-to-treat
The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
Outcome measures
| Measure |
Low Dose MDMA (30 mg)
n=7 Participants
Participants will receive 30 mg MDMA during each of two blinded experimental sessions.
Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later
Psychotherapy: Non-directive psychotherapy during each session
|
Medium Dose MDMA (75 mg)
n=7 Participants
Participants will receive 75 mg MDMA on each of two blinded experimental sessions
Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg
Psychotherapy: Non-directive psychotherapy during each session
|
Full Dose MDMA (125 mg)
n=12 Participants
Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.
Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.
Psychotherapy: Non-directive psychotherapy during each session
|
|---|---|---|---|
|
Change in Global Assessment of Function (GAF) From Baseline to Primary Endpoint
|
1.1 score on a scale
Standard Deviation 4.6
|
19.4 score on a scale
Standard Deviation 6.1
|
18.4 score on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Baseline to one month after second experimental sessionPopulation: Intent-to-treat
The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains five subscales; relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life. Questions are answered on a scale from 0 (I did not experience this change) to 5 (I experienced this change to a great degree). Items are added to calculate the total PTGI score which ranges from 0 to 105, with higher scores indicative of greater growth.
Outcome measures
| Measure |
Low Dose MDMA (30 mg)
n=7 Participants
Participants will receive 30 mg MDMA during each of two blinded experimental sessions.
Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later
Psychotherapy: Non-directive psychotherapy during each session
|
Medium Dose MDMA (75 mg)
n=7 Participants
Participants will receive 75 mg MDMA on each of two blinded experimental sessions
Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg
Psychotherapy: Non-directive psychotherapy during each session
|
Full Dose MDMA (125 mg)
n=12 Participants
Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.
Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.
Psychotherapy: Non-directive psychotherapy during each session
|
|---|---|---|---|
|
Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint
|
-11.6 score on a scale
Standard Deviation 12.2
|
36.1 score on a scale
Standard Deviation 12.0
|
33.7 score on a scale
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: Baseline to one month after second experimental sessionPopulation: Intent-to-treat
Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
Outcome measures
| Measure |
Low Dose MDMA (30 mg)
n=7 Participants
Participants will receive 30 mg MDMA during each of two blinded experimental sessions.
Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later
Psychotherapy: Non-directive psychotherapy during each session
|
Medium Dose MDMA (75 mg)
n=7 Participants
Participants will receive 75 mg MDMA on each of two blinded experimental sessions
Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg
Psychotherapy: Non-directive psychotherapy during each session
|
Full Dose MDMA (125 mg)
n=12 Participants
Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.
Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.
Psychotherapy: Non-directive psychotherapy during each session
|
|---|---|---|---|
|
Change in Beck Depression Inventory (BDI-II) From Baseline to Primary Endpoint
|
-4.6 score on a scale
Standard Deviation 8.8
|
-15.4 score on a scale
Standard Deviation 9.5
|
-24.6 score on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline to one month after second experimental sessionPopulation: Intent-to-treat \[Note: The DES-II was added as an outcome measure in Protocol Amendment 5 so was not collected in participants who completed the study under an earlier version of the protocol (n=14).\]
The DES-II is a 28-item self-report measure of dissociation, defined as a lack of normal integration of an individual's thoughts, feelings, or experiences into the stream of consciousness or memory. Respondents indicate how often the specific experience happens to them, from "never" (0% of the time) to "always" (100%). The scale is scored by treating percentages as single digits and summing to produce a total score, ranging from 0 to 100. The higher the score, the more dissociative symptoms.
Outcome measures
| Measure |
Low Dose MDMA (30 mg)
n=3 Participants
Participants will receive 30 mg MDMA during each of two blinded experimental sessions.
Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later
Psychotherapy: Non-directive psychotherapy during each session
|
Medium Dose MDMA (75 mg)
n=3 Participants
Participants will receive 75 mg MDMA on each of two blinded experimental sessions
Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg
Psychotherapy: Non-directive psychotherapy during each session
|
Full Dose MDMA (125 mg)
n=6 Participants
Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.
Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.
Psychotherapy: Non-directive psychotherapy during each session
|
|---|---|---|---|
|
Change in Dissociative Experience Scale (DES-II) From Baseline to Primary Endpoint
|
1.8 score on a scale
Standard Deviation 0.95
|
-8.6 score on a scale
Standard Deviation 1.9
|
-8.8 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Baseline to one month after second experimental sessionPopulation: Intent-to-treat \[Note: The PSQI was added as an outcome measure in Protocol Amendment 3 so was not collected in participants who completed the study under an earlier version of the protocol (n=6).\]
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
Outcome measures
| Measure |
Low Dose MDMA (30 mg)
n=5 Participants
Participants will receive 30 mg MDMA during each of two blinded experimental sessions.
Low dose MDMA: 30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later
Psychotherapy: Non-directive psychotherapy during each session
|
Medium Dose MDMA (75 mg)
n=5 Participants
Participants will receive 75 mg MDMA on each of two blinded experimental sessions
Medium dose MDMA: 75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg
Psychotherapy: Non-directive psychotherapy during each session
|
Full Dose MDMA (125 mg)
n=10 Participants
Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.
Full dose MDMA: 125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.
Psychotherapy: Non-directive psychotherapy during each session
|
|---|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Primary Endpoint
|
1.8 score on a scale
Standard Deviation 2.8
|
-6.4 score on a scale
Standard Deviation 7.1
|
-4.8 score on a scale
Standard Deviation 4.1
|
Adverse Events
Blinded Low Dose MDMA-assisted Therapy
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Blinded Medium Dose MDMA-assisted Therapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Blinded Full Dose MDMA-assisted Therapy
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Open-Label Low Dose MDMA-assisted Therapy
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Open-Label Medium Dose MDMA-assisted Therapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Open-Label Full Dose MDMA-assisted Therapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Low Dose Group 12 Month Follow-Up
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Medium Dose Group 12 Month Follow-Up
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Full Dose Group 12 Month Follow-Up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRRS: Low Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
SRRs: Medium Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
SRRs: Full Dose
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Blinded Low Dose MDMA-assisted Therapy
n=7 participants at risk
Participants will receive 30 mg midomafetamine HCl with therapy during each of two blinded experimental sessions.
|
Blinded Medium Dose MDMA-assisted Therapy
n=7 participants at risk
Participants will receive 75 mg midomafetamine HCl with therapy on each of two blinded experimental sessions
|
Blinded Full Dose MDMA-assisted Therapy
n=12 participants at risk
Participants will receive 125 mg midomafetamine HCl with therapy during each of two blinded experimental sessions, followed by a third open label session.
|
Open-Label Low Dose MDMA-assisted Therapy
n=6 participants at risk
Participants who received two sessions of blinded low dose MDMA-assisted therapy were given the option to cross over and receive three additional open-label MDMA-assisted therapy sessions with 100 mg of midomafetamine HCl
|
Open-Label Medium Dose MDMA-assisted Therapy
n=6 participants at risk
Participants who received two sessions of blinded medium dose MDMA-assisted therapy were given the option to cross over and receive three additional open-label MDMA-assisted therapy sessions with 100 mg of midomafetamine HCl
|
Open-Label Full Dose MDMA-assisted Therapy
n=12 participants at risk
Participants who received two sessions of blinded full dose MDMA-assisted therapy received a third open-label session with 125 mg midomafetamine HCl
|
Low Dose Group 12 Month Follow-Up
n=6 participants at risk
Participants followed for 12 months from end of Stage or 2
|
Medium Dose Group 12 Month Follow-Up
n=7 participants at risk
Participants followed for 12 months from end of Stage or 2
|
Full Dose Group 12 Month Follow-Up
n=11 participants at risk
Participants followed for 12 months from end of Stage or 2
|
SRRS: Low Dose
n=7 participants at risk
Spontaneously reported reactions (SRRs) on day of blinded experimental sessions and 7 days after.
|
SRRs: Medium Dose
n=7 participants at risk
Spontaneously reported reactions (SRRs) on day of blinded experimental sessions and 7 days after.
|
SRRs: Full Dose
n=12 participants at risk
Spontaneously reported reactions (SRRs) on day of blinded experimental sessions and 7 days after.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
Other adverse events
| Measure |
Blinded Low Dose MDMA-assisted Therapy
n=7 participants at risk
Participants will receive 30 mg midomafetamine HCl with therapy during each of two blinded experimental sessions.
|
Blinded Medium Dose MDMA-assisted Therapy
n=7 participants at risk
Participants will receive 75 mg midomafetamine HCl with therapy on each of two blinded experimental sessions
|
Blinded Full Dose MDMA-assisted Therapy
n=12 participants at risk
Participants will receive 125 mg midomafetamine HCl with therapy during each of two blinded experimental sessions, followed by a third open label session.
|
Open-Label Low Dose MDMA-assisted Therapy
n=6 participants at risk
Participants who received two sessions of blinded low dose MDMA-assisted therapy were given the option to cross over and receive three additional open-label MDMA-assisted therapy sessions with 100 mg of midomafetamine HCl
|
Open-Label Medium Dose MDMA-assisted Therapy
n=6 participants at risk
Participants who received two sessions of blinded medium dose MDMA-assisted therapy were given the option to cross over and receive three additional open-label MDMA-assisted therapy sessions with 100 mg of midomafetamine HCl
|
Open-Label Full Dose MDMA-assisted Therapy
n=12 participants at risk
Participants who received two sessions of blinded full dose MDMA-assisted therapy received a third open-label session with 125 mg midomafetamine HCl
|
Low Dose Group 12 Month Follow-Up
n=6 participants at risk
Participants followed for 12 months from end of Stage or 2
|
Medium Dose Group 12 Month Follow-Up
n=7 participants at risk
Participants followed for 12 months from end of Stage or 2
|
Full Dose Group 12 Month Follow-Up
n=11 participants at risk
Participants followed for 12 months from end of Stage or 2
|
SRRS: Low Dose
n=7 participants at risk
Spontaneously reported reactions (SRRs) on day of blinded experimental sessions and 7 days after.
|
SRRs: Medium Dose
n=7 participants at risk
Spontaneously reported reactions (SRRs) on day of blinded experimental sessions and 7 days after.
|
SRRs: Full Dose
n=12 participants at risk
Spontaneously reported reactions (SRRs) on day of blinded experimental sessions and 7 days after.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Muscle Tension
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
28.6%
2/7 • During entire study duration (approx 12 months)
|
42.9%
3/7 • During entire study duration (approx 12 months)
|
58.3%
7/12 • During entire study duration (approx 12 months)
|
|
General disorders
Need More Sleep
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
85.7%
6/7 • During entire study duration (approx 12 months)
|
85.7%
6/7 • During entire study duration (approx 12 months)
|
75.0%
9/12 • During entire study duration (approx 12 months)
|
|
General disorders
Perspiration
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
General disorders
Restlessness
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
|
General disorders
Ruminations
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
|
General disorders
Sensitivity to Cold
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
28.6%
2/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
General disorders
Weakness
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Eye disorders
Visual impairment
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
28.6%
2/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
16.7%
2/12 • During entire study duration (approx 12 months)
|
|
Gastrointestinal disorders
Hordeolum
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
16.7%
2/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Injury, poisoning and procedural complications
Venomous sting
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Psychiatric disorders
Tic
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Psychiatric disorders
Trichotillomania
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Skin and subcutaneous tissue disorders
Constipation
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
General disorders
Fatigue
|
28.6%
2/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
85.7%
6/7 • During entire study duration (approx 12 months)
|
100.0%
7/7 • During entire study duration (approx 12 months)
|
83.3%
10/12 • During entire study duration (approx 12 months)
|
|
Infections and infestations
Sinusitis
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Infections and infestations
Influenza
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Infections and infestations
Tooth abcess
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Infections and infestations
Ligament sprain
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Sleep deficit
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
50.0%
3/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Anxiety
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
33.3%
2/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
57.1%
4/7 • During entire study duration (approx 12 months)
|
71.4%
5/7 • During entire study duration (approx 12 months)
|
83.3%
10/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Depressed mood
|
28.6%
2/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Flashback
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Insomnia
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
71.4%
5/7 • During entire study duration (approx 12 months)
|
42.9%
3/7 • During entire study duration (approx 12 months)
|
83.3%
10/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Intrusive thoughts
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Irritability
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Time perception altered
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Pseudofolliculitis
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Urticaria
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Migraine
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Suicidal ideation
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
General disorders
Cyst
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
33.3%
2/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Psychiatric disorders
Hypnagogic hallucination
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Psychiatric disorders
Hypnopompic hallucination
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
16.7%
1/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
33.3%
2/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
General disorders
Difficulty Concentrating
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
28.6%
2/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
41.7%
5/12 • During entire study duration (approx 12 months)
|
|
General disorders
Dizziness
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
16.7%
2/12 • During entire study duration (approx 12 months)
|
|
General disorders
Drowsiness
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
|
General disorders
Dry Mouth
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
|
General disorders
Headache
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
28.6%
2/7 • During entire study duration (approx 12 months)
|
42.9%
3/7 • During entire study duration (approx 12 months)
|
58.3%
7/12 • During entire study duration (approx 12 months)
|
|
General disorders
Impaired Judgment
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
|
General disorders
Impaired Gait/Balance
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
8.3%
1/12 • During entire study duration (approx 12 months)
|
|
General disorders
Increased Irritability
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
57.1%
4/7 • During entire study duration (approx 12 months)
|
28.6%
2/7 • During entire study duration (approx 12 months)
|
50.0%
6/12 • During entire study duration (approx 12 months)
|
|
General disorders
Jaw Clenching, Tight Jaw
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
28.6%
2/7 • During entire study duration (approx 12 months)
|
25.0%
3/12 • During entire study duration (approx 12 months)
|
|
General disorders
Lack of Appetite
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
28.6%
2/7 • During entire study duration (approx 12 months)
|
14.3%
1/7 • During entire study duration (approx 12 months)
|
50.0%
6/12 • During entire study duration (approx 12 months)
|
|
General disorders
Low Mood
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/12 • During entire study duration (approx 12 months)
|
0.00%
0/6 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
0.00%
0/11 • During entire study duration (approx 12 months)
|
42.9%
3/7 • During entire study duration (approx 12 months)
|
0.00%
0/7 • During entire study duration (approx 12 months)
|
25.0%
3/12 • During entire study duration (approx 12 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60