Trial Outcomes & Findings for A Study of TAK-861 in Participants With Narcolepsy Type 1 (NCT NCT05687903)
NCT ID: NCT05687903
Last Updated: 2025-01-09
Results Overview
The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2025-01-09
Participant Flow
Participants took part in the study at 33 investigative sites globally from 09 January 2023 to 14 December 2023.
Participants with a diagnosis of narcolepsy type 1 (NT1) were enrolled in the study to receive either TAK-861 or placebo.
Participant milestones
| Measure |
Placebo
Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.
|
TAK-861 0.5 mg BID
Participants received TAK-861 0.5 milligrams (mg), orally, BID, from Days 1 to 56.
|
TAK-861 2 mg BID
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg and 5 mg
Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
|
TAK-861 7 mg QD
Participants received TAK-861 7 mg, orally, once daily (QD), from Days 1 to 56. Placebo was given as the second dose.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
21
|
23
|
23
|
|
Overall Study
COMPLETED
|
21
|
22
|
21
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.
|
TAK-861 0.5 mg BID
Participants received TAK-861 0.5 milligrams (mg), orally, BID, from Days 1 to 56.
|
TAK-861 2 mg BID
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg and 5 mg
Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
|
TAK-861 7 mg QD
Participants received TAK-861 7 mg, orally, once daily (QD), from Days 1 to 56. Placebo was given as the second dose.
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Deviation
|
1
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Number analyzed is the number of participants with data available for analyses at Baseline.
Baseline characteristics by cohort
| Measure |
Placebo
n=22 Participants
Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.
|
TAK-861 0.5 mg BID
n=23 Participants
Participants received TAK-861 0.5 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg BID
n=21 Participants
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg and 5 mg
n=23 Participants
Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
|
TAK-861 7 mg QD
n=23 Participants
Participants received TAK-861 7 mg, orally, QD, from Days 1 to 56. Placebo was given as the second dose.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 11.86 • n=22 Participants
|
32.7 years
STANDARD_DEVIATION 11.06 • n=23 Participants
|
31.7 years
STANDARD_DEVIATION 11.31 • n=21 Participants
|
34.7 years
STANDARD_DEVIATION 11.48 • n=23 Participants
|
33.3 years
STANDARD_DEVIATION 11.94 • n=23 Participants
|
34 years
STANDARD_DEVIATION 11.5 • n=112 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=22 Participants
|
11 Participants
n=23 Participants
|
9 Participants
n=21 Participants
|
14 Participants
n=23 Participants
|
10 Participants
n=23 Participants
|
58 Participants
n=112 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=22 Participants
|
12 Participants
n=23 Participants
|
12 Participants
n=21 Participants
|
9 Participants
n=23 Participants
|
13 Participants
n=23 Participants
|
54 Participants
n=112 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=23 Participants
|
8 Participants
n=112 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=22 Participants
|
21 Participants
n=23 Participants
|
20 Participants
n=21 Participants
|
23 Participants
n=23 Participants
|
20 Participants
n=23 Participants
|
103 Participants
n=112 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=112 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=23 Participants
|
2 Participants
n=23 Participants
|
8 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
6 Participants
n=112 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=22 Participants
|
19 Participants
n=23 Participants
|
19 Participants
n=21 Participants
|
19 Participants
n=23 Participants
|
20 Participants
n=23 Participants
|
96 Participants
n=112 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=112 Participants
|
|
Average Sleep Latency From the Maintenance of Wakefulness Test (MWT)
|
6.1 minutes
STANDARD_DEVIATION 8.82 • n=22 Participants • Number analyzed is the number of participants with data available for analyses at Baseline.
|
5.6 minutes
STANDARD_DEVIATION 7.89 • n=23 Participants • Number analyzed is the number of participants with data available for analyses at Baseline.
|
3.9 minutes
STANDARD_DEVIATION 5.98 • n=21 Participants • Number analyzed is the number of participants with data available for analyses at Baseline.
|
4.2 minutes
STANDARD_DEVIATION 3.63 • n=22 Participants • Number analyzed is the number of participants with data available for analyses at Baseline.
|
3.6 minutes
STANDARD_DEVIATION 4.87 • n=23 Participants • Number analyzed is the number of participants with data available for analyses at Baseline.
|
4.7 minutes
STANDARD_DEVIATION 6.48 • n=111 Participants • Number analyzed is the number of participants with data available for analyses at Baseline.
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Full Analysis Set included all participants who were randomized and received at least one dose of study drug and had at least one post-dose efficacy measurement. Overall number of participants analyzed is the number of participants with data available for analyses.
The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.
|
TAK-861 0.5 mg BID
n=19 Participants
Participants received TAK-861 0.5 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg BID
n=21 Participants
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg and 5 mg
n=20 Participants
Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
|
TAK-861 7 mg QD
n=23 Participants
Participants received TAK-861 7 mg, orally, QD, from Days 1 to 56. Placebo was given as the second dose.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8
|
-1.16 minutes
Standard Error 2.061
|
12.49 minutes
Standard Error 2.128
|
23.50 minutes
Standard Error 2.042
|
25.42 minutes
Standard Error 2.071
|
14.96 minutes
Standard Error 1.953
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Full Analysis Set included all participants who were randomized and received at least one dose of study drug and had at least one post-dose efficacy measurement. Overall number of participants analyzed is the number of participants with data available for analyses.
The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks participants how likely they are to fall asleep in those situations. The scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range. The MMRM was used for analysis.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.
|
TAK-861 0.5 mg BID
n=21 Participants
Participants received TAK-861 0.5 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg BID
n=21 Participants
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg and 5 mg
n=22 Participants
Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
|
TAK-861 7 mg QD
n=23 Participants
Participants received TAK-861 7 mg, orally, QD, from Days 1 to 56. Placebo was given as the second dose.
|
|---|---|---|---|---|---|
|
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8
|
-2.50 score on a scale
Standard Error 1.109
|
-8.92 score on a scale
Standard Error 1.085
|
-13.79 score on a scale
Standard Error 1.115
|
-12.81 score on a scale
Standard Error 1.073
|
-11.29 score on a scale
Standard Error 1.064
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set included all participants who were randomized and received at least one dose of study drug and had at least one post-dose efficacy measurement. Overall number of participants analyzed is the number of participants with data available for analyses.
Participants completed a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants recorded episodes of cataplexy attacks in the diary. The total number of events averaged for a week were reported. WCR = (total number of cataplexy attacks over a number of non-missing diary days for a given duration/number of non-missing diary days in that duration)\*7. The generalized estimating equations (GEE) model was used for analysis.
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.
|
TAK-861 0.5 mg BID
n=21 Participants
Participants received TAK-861 0.5 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg BID
n=21 Participants
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg and 5 mg
n=22 Participants
Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
|
TAK-861 7 mg QD
n=23 Participants
Participants received TAK-861 7 mg, orally, QD, from Days 1 to 56. Placebo was given as the second dose.
|
|---|---|---|---|---|---|
|
Weekly Cataplexy Rate (WCR) at Week 8
|
8.76 cataplexy attacks per week
Interval 5.68 to 13.51
|
4.24 cataplexy attacks per week
Interval 2.6 to 6.92
|
3.14 cataplexy attacks per week
Interval 1.65 to 5.98
|
2.48 cataplexy attacks per week
Interval 1.3 to 4.73
|
5.89 cataplexy attacks per week
Interval 3.64 to 9.53
|
SECONDARY outcome
Timeframe: From first dose of the study drug up to end of the study (up to 3 months)Population: Safety Analysis Set included all participants who received at least one dose of study drug.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence was considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurred after receiving study drug.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.
|
TAK-861 0.5 mg BID
n=23 Participants
Participants received TAK-861 0.5 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg BID
n=21 Participants
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg and 5 mg
n=23 Participants
Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
|
TAK-861 7 mg QD
n=23 Participants
Participants received TAK-861 7 mg, orally, QD, from Days 1 to 56. Placebo was given as the second dose.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
|
7 Participants
|
13 Participants
|
15 Participants
|
21 Participants
|
21 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TAK-861 0.5 mg BID
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
TAK-861 2 mg BID
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
TAK-861 2 mg/5 mg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
TAK-861 7 mg QD
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=22 participants at risk
Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.
|
TAK-861 0.5 mg BID
n=23 participants at risk
Participants received TAK-861 0.5 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg BID
n=21 participants at risk
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg/5 mg
n=23 participants at risk
Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
|
TAK-861 7 mg QD
n=23 participants at risk
Participants received TAK-861 7 mg, orally, QD, from Days 1 to 56. Placebo was given as the second dose.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
4.3%
1/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=22 participants at risk
Participants received placebo tablets matching TAK-861, orally, BID, from Days 1 to 56.
|
TAK-861 0.5 mg BID
n=23 participants at risk
Participants received TAK-861 0.5 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg BID
n=21 participants at risk
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
|
TAK-861 2 mg/5 mg
n=23 participants at risk
Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
|
TAK-861 7 mg QD
n=23 participants at risk
Participants received TAK-861 7 mg, orally, QD, from Days 1 to 56. Placebo was given as the second dose.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
8.7%
2/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
4.3%
1/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
8.7%
2/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
8.7%
2/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
4.3%
1/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
14.3%
3/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
8.7%
2/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
8.7%
2/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Increased appetite
|
4.5%
1/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
4.3%
1/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
4.3%
1/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
21.7%
5/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
47.6%
10/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
56.5%
13/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
65.2%
15/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
4.5%
1/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
21.7%
5/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
19.0%
4/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
52.2%
12/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
39.1%
9/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
4.3%
1/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
13.0%
3/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
8.7%
2/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
8.7%
2/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
8.7%
2/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
4.5%
1/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
13.0%
3/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
33.3%
7/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
30.4%
7/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
52.2%
12/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
8.7%
2/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
0.00%
0/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
4.5%
1/22 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
8.7%
2/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
9.5%
2/21 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
26.1%
6/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
8.7%
2/23 • From first dose of the study drug up to end of the study (up to 3 months)
Safety Analysis Set included all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place