Trial Outcomes & Findings for Study to Evaluate SAGE-324 in Participants With Essential Tremor (NCT NCT05173012)
NCT ID: NCT05173012
Last Updated: 2025-05-16
Results Overview
TETRAS is a clinical evaluation of essential tremor. The TETRAS performance subscale upper limb tremor score is a component of TETRAS. For the TETRAS Performance Subscale Item 4 (upper limb), three maneuvers/assessments were to be completed for both arms, first for the right arm and then for the left, specifically Item 4a, limbs extended forward maneuver (postural tremor), Item 4b, wing-beating \[elbows flexed\] maneuver (postural tremor), and Item 4c finger-nose-finger maneuver (kinetic tremor). Each assessment is rated on a 0 to 4 scale of severity in 0.5-point increments, with higher scores indicating more severe tremor. The Performance Subscale Item 4 (upper limb) total score range for a given side (left or right) is 0 to 12, and for both sides combined is 0 to 24. A negative change from baseline indicates improvement. Mixed model for repeated measures (MMRM) was used for the analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
Baseline, Day 91
Results posted on
2025-05-16
Participant Flow
Participants were enrolled at 51 investigative sites in the United States from 05 Jan 2022 to 16 May 2024.
A total of 160 participants were planned for the study, of which 147 participants were randomized. Out of 147, 1 participant was randomized in error but was not assigned in any of the treatment group. This participant did not receive any treatment, therefore only146 participants received IP.
Participant milestones
| Measure |
Monotherapy: Placebo
Participants received SAGE-324 matched placebo, orally, once daily (QD), in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 15 mg
Participants received SAGE-324 15 milligrams (mg), orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 30 mg
Participants received SAGE-324 30 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 60 mg
Participants received SAGE-324 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: Placebo
Participants received SAGE-324 matched placebo, orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 15 mg
Participants received SAGE-324 15 mg, orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 30 mg
Participants received SAGE-324, 30 mg orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 60 mg
Participants received SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, orally, QD, in the evening along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
32
|
33
|
4
|
4
|
5
|
5
|
|
Overall Study
COMPLETED
|
28
|
29
|
27
|
13
|
3
|
4
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
5
|
20
|
1
|
0
|
3
|
4
|
Reasons for withdrawal
| Measure |
Monotherapy: Placebo
Participants received SAGE-324 matched placebo, orally, once daily (QD), in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 15 mg
Participants received SAGE-324 15 milligrams (mg), orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 30 mg
Participants received SAGE-324 30 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 60 mg
Participants received SAGE-324 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: Placebo
Participants received SAGE-324 matched placebo, orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 15 mg
Participants received SAGE-324 15 mg, orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 30 mg
Participants received SAGE-324, 30 mg orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 60 mg
Participants received SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, orally, QD, in the evening along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
4
|
13
|
0
|
0
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
3
|
1
|
0
|
1
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The number analyzed indicates the number of participants with data available for analysis.
Baseline characteristics by cohort
| Measure |
Monotherapy: Placebo
n=31 Participants
Participants received SAGE-324 matched placebo, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 15 mg
n=32 Participants
Participants received SAGE-324 15 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 30 mg
n=32 Participants
Participants received SAGE-324 30 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 60 mg
n=33 Participants
Participants received SAGE-324 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: Placebo
n=4 Participants
Participants received SAGE-324 matched placebo, orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 15 mg
n=4 Participants
Participants received SAGE-324 15 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 30 mg
n=5 Participants
Participants received SAGE-324, 30 mg orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 60 mg
n=5 Participants
Participants received SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 9.35 • n=31 Participants
|
65.8 years
STANDARD_DEVIATION 11.25 • n=32 Participants
|
66.9 years
STANDARD_DEVIATION 10.18 • n=32 Participants
|
69.5 years
STANDARD_DEVIATION 7.67 • n=33 Participants
|
65.8 years
STANDARD_DEVIATION 11.95 • n=4 Participants
|
69.3 years
STANDARD_DEVIATION 11.59 • n=4 Participants
|
67.4 years
STANDARD_DEVIATION 7.57 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 8.87 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 9.60 • n=146 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=31 Participants
|
11 Participants
n=32 Participants
|
10 Participants
n=32 Participants
|
14 Participants
n=33 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
54 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=31 Participants
|
21 Participants
n=32 Participants
|
22 Participants
n=32 Participants
|
19 Participants
n=33 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
92 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=31 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
4 Participants
n=33 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=31 Participants
|
31 Participants
n=32 Participants
|
31 Participants
n=32 Participants
|
29 Participants
n=33 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
139 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=33 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=31 Participants
|
32 Participants
n=32 Participants
|
30 Participants
n=32 Participants
|
31 Participants
n=33 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
139 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=33 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=146 Participants
|
|
The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 (Upper Limb) Score
|
13.68 score on a scale
STANDARD_DEVIATION 1.249 • n=31 Participants • The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The number analyzed indicates the number of participants with data available for analysis.
|
13.69 score on a scale
STANDARD_DEVIATION 1.430 • n=32 Participants • The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The number analyzed indicates the number of participants with data available for analysis.
|
13.10 score on a scale
STANDARD_DEVIATION 1.625 • n=31 Participants • The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The number analyzed indicates the number of participants with data available for analysis.
|
13.39 score on a scale
STANDARD_DEVIATION 1.633 • n=33 Participants • The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The number analyzed indicates the number of participants with data available for analysis.
|
12.50 score on a scale
STANDARD_DEVIATION 0.577 • n=4 Participants • The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The number analyzed indicates the number of participants with data available for analysis.
|
14.25 score on a scale
STANDARD_DEVIATION 2.843 • n=4 Participants • The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The number analyzed indicates the number of participants with data available for analysis.
|
13.20 score on a scale
STANDARD_DEVIATION 0.758 • n=5 Participants • The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The number analyzed indicates the number of participants with data available for analysis.
|
13.00 score on a scale
STANDARD_DEVIATION 0.935 • n=5 Participants • The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The number analyzed indicates the number of participants with data available for analysis.
|
13.43 score on a scale
STANDARD_DEVIATION 1.492 • n=145 Participants • The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The number analyzed indicates the number of participants with data available for analysis.
|
PRIMARY outcome
Timeframe: Baseline, Day 91Population: The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The overall number of participants analyzed indicates the number of participants with data available for outcome measure analysis.
TETRAS is a clinical evaluation of essential tremor. The TETRAS performance subscale upper limb tremor score is a component of TETRAS. For the TETRAS Performance Subscale Item 4 (upper limb), three maneuvers/assessments were to be completed for both arms, first for the right arm and then for the left, specifically Item 4a, limbs extended forward maneuver (postural tremor), Item 4b, wing-beating \[elbows flexed\] maneuver (postural tremor), and Item 4c finger-nose-finger maneuver (kinetic tremor). Each assessment is rated on a 0 to 4 scale of severity in 0.5-point increments, with higher scores indicating more severe tremor. The Performance Subscale Item 4 (upper limb) total score range for a given side (left or right) is 0 to 12, and for both sides combined is 0 to 24. A negative change from baseline indicates improvement. Mixed model for repeated measures (MMRM) was used for the analysis.
Outcome measures
| Measure |
Monotherapy: Placebo
n=28 Participants
Participants received SAGE-324 matched placebo, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 15 mg
n=28 Participants
Participants received SAGE-324 15 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 30 mg
n=27 Participants
Participants received SAGE-324 30 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 60 mg
n=13 Participants
Participants received SAGE-324 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 (Upper Limb) Total Score on Day 91 in the Monotherapy Cohort
|
-2.53 score on a scale
Standard Error 0.445
|
-2.14 score on a scale
Standard Error 0.436
|
-2.81 score on a scale
Standard Error 0.449
|
-1.51 score on a scale
Standard Error 0.540
|
SECONDARY outcome
Timeframe: Baseline, Day 91Population: The Full Analysis Set included all randomized participants who received any amount of IP and had a baseline and at least one post-baseline TETRAS Performance Subscale Item 4 (upper limb tremor) total score. The overall number of participants analyzed indicates the number of participants with data available for analysis at specified timepoint.
TETRAS ADL Subscale (items 1-12) assesses how ET affects typical ADL (speech, eating, drinking, dressing, personal hygiene, writing, occupational impairment, social impact, activities affected by UL tremor). TETRAS ADL composite score comprises Items 1-11 of ADL Subscale (Item 1: speech impairment; Item 10: occupational impairment; remaining 9 items: impairment in activities affected by UL tremor) and Item 6 of Performance Subscale (spiral drawing). Each of individual item is rated on a scale from 0 (normal activity) to 4 (severe abnormality); responses of 0 \& 1 in TETRAS ADL Subscale Items 1 to 11 were collapsed such that scale is 0 (normal/slightly abnormal), 1 (mildly abnormal), 2 (moderately abnormal), and 3 (severely abnormal). Performance Subscale Item 6 responses were collapsed with responses having 0.5 point increments grouped with next higher integer response. ADL composite score range is 0 to 39. Higher score=greater abnormality, negative change=improvement.
Outcome measures
| Measure |
Monotherapy: Placebo
n=28 Participants
Participants received SAGE-324 matched placebo, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 15 mg
n=28 Participants
Participants received SAGE-324 15 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 30 mg
n=27 Participants
Participants received SAGE-324 30 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 60 mg
n=13 Participants
Participants received SAGE-324 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in TETRAS Activities of Daily Living (ADL) Composite Score in the Monotherapy Cohort
|
-4.51 score on a scale
Standard Error 0.951
|
-2.48 score on a scale
Standard Error 0.921
|
-5.29 score on a scale
Standard Error 0.948
|
-3.51 score on a scale
Standard Error 1.080
|
Adverse Events
Monotherapy: Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Monotherapy: SAGE-324 15 mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Monotherapy: SAGE-324 30 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Monotherapy: SAGE-324 60 mg
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Adjunct Therapy: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Adjunct Therapy: SAGE-324 15 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Adjunct Therapy: SAGE-324 30 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Adjunct Therapy: SAGE-324 60 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monotherapy: Placebo
n=31 participants at risk
Participants received SAGE-324 matched placebo, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 15 mg
n=32 participants at risk
Participants received SAGE-324 15 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 30 mg
n=32 participants at risk
Participants received SAGE-324 30 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 60 mg
n=33 participants at risk
Participants received SAGE-324 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: Placebo
n=4 participants at risk
Participants received SAGE-324 matched placebo, orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 15 mg
n=4 participants at risk
Participants received SAGE-324 15 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 30 mg
n=5 participants at risk
Participants received SAGE-324, 30 mg orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 60 mg
n=5 participants at risk
Participants received SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.1%
1/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.0%
1/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
Other adverse events
| Measure |
Monotherapy: Placebo
n=31 participants at risk
Participants received SAGE-324 matched placebo, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 15 mg
n=32 participants at risk
Participants received SAGE-324 15 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 30 mg
n=32 participants at risk
Participants received SAGE-324 30 mg, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Monotherapy: SAGE-324 60 mg
n=33 participants at risk
Participants received SAGE-324 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, orally, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: Placebo
n=4 participants at risk
Participants received SAGE-324 matched placebo, orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 15 mg
n=4 participants at risk
Participants received SAGE-324 15 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 30 mg
n=5 participants at risk
Participants received SAGE-324, 30 mg orally, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
Adjunct Therapy: SAGE-324 60 mg
n=5 participants at risk
Participants received SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to screening up to Day 90 in a double-blind treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
3.2%
1/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
15.6%
5/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
25.0%
8/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
24.2%
8/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.1%
1/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
15.6%
5/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
18.2%
6/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.1%
1/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
15.2%
5/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
9.4%
3/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.1%
2/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
25.0%
1/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.1%
1/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
9.1%
3/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.1%
2/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
General disorders
Fatigue
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
9.4%
3/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
9.4%
3/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
12.1%
4/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
40.0%
2/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
General disorders
Feeling abnormal
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.2%
2/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
12.1%
4/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.1%
1/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.2%
2/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
9.4%
3/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.0%
1/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.2%
2/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.0%
1/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.1%
1/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.1%
2/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Psychiatric disorders
Depression
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
9.1%
3/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.2%
2/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.2%
2/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.1%
2/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.2%
2/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
2/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.1%
2/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Vascular disorders
Hypertension
|
9.7%
3/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.0%
1/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
6.2%
2/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.0%
1/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Nervous system disorders
Slow speech
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Infections and infestations
COVID-19
|
3.2%
1/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
25.0%
1/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.1%
1/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.1%
1/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
25.0%
1/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
25.0%
1/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
General disorders
Gait disturbance
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.0%
1/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
25.0%
1/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Investigations
Blood urea increased
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
40.0%
2/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.5%
2/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
3.1%
1/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Investigations
Platelet count decreased
|
3.2%
1/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Investigations
Heart rate increased
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
25.0%
1/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
25.0%
1/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Renal and urinary disorders
Dyspnoea
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/31 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/32 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/33 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/4 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
0.00%
0/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
20.0%
1/5 • Up to Day 104
The Safety Analysis Set included all participants who were administered IP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
- Publication restrictions are in place
Restriction type: OTHER