Trial Outcomes & Findings for Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor (NCT NCT03292458)
NCT ID: NCT03292458
Last Updated: 2025-12-30
Results Overview
A combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity before and after drug vs. placebo intake. For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
117 participants
Primary outcome timeframe
40 min after drug or placebo administration
Results posted on
2025-12-30
Participant Flow
The study was conducted between January 22, 2018, and December 29, 2021. The COVID-19 pandemic and the associated lockdown of human research activities fully paused patient recruitment and the conduct of study procedures between March 2020 and December 2020.
Pre-specified to LD patients with and without dystonic voice tremor regardless of alcohol responsiveness of symptoms. 9 patients were excluded because of a history of suicidal ideations (n= 3), absence of symptoms at the time of study participation (n= 3), left-handedness (n= 1), presence of multifocal dystonia (n= 1), and contraindications to MRI (n= 1).
Participant milestones
| Measure |
Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Sodium Oxybate, Then Placebo
Participants with alcohol-responsive and non-responsive LD with/without dystonic tremor of voice first received a single dose of oral solution of sodium oxybate 1.5 g. After a 24-hour washout period, they then received oral solution of placebo (matching sodium oxybate 1.5 g).
According to a priori hypothesis, the analysis was conducted based on the alcohol-responsiveness of symptoms, regardless of period sequence.
Baseline measures are described based on LD phenotype and alcohol-responsiveness for detailed cohort description.
|
Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Placebo, Then Sodium Oxybate
Participants with alcohol-responsive and non-responsive LD with/without dystonic tremor of voice first received a single dose of oral solution of placebo (matching sodium oxybate 1.5 g). After a 24-hour washout period, they then received oral solution of sodium oxybate 1.5 g.
According to a priori hypothesis, the analysis was conducted based on the alcohol-responsiveness of symptoms, regardless of period sequence.
Baseline measures are described based on LD phenotype and alcohol-responsiveness for detailed cohort description.
|
|---|---|---|
|
Period 1
STARTED
|
55
|
53
|
|
Period 1
COMPLETED
|
53
|
53
|
|
Period 1
NOT COMPLETED
|
2
|
0
|
|
Period 2
STARTED
|
53
|
53
|
|
Period 2
COMPLETED
|
53
|
53
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Sodium Oxybate, Then Placebo
Participants with alcohol-responsive and non-responsive LD with/without dystonic tremor of voice first received a single dose of oral solution of sodium oxybate 1.5 g. After a 24-hour washout period, they then received oral solution of placebo (matching sodium oxybate 1.5 g).
According to a priori hypothesis, the analysis was conducted based on the alcohol-responsiveness of symptoms, regardless of period sequence.
Baseline measures are described based on LD phenotype and alcohol-responsiveness for detailed cohort description.
|
Laryngeal Dystonia With and Without Dystonic Tremor of Voice: Placebo, Then Sodium Oxybate
Participants with alcohol-responsive and non-responsive LD with/without dystonic tremor of voice first received a single dose of oral solution of placebo (matching sodium oxybate 1.5 g). After a 24-hour washout period, they then received oral solution of sodium oxybate 1.5 g.
According to a priori hypothesis, the analysis was conducted based on the alcohol-responsiveness of symptoms, regardless of period sequence.
Baseline measures are described based on LD phenotype and alcohol-responsiveness for detailed cohort description.
|
|---|---|---|
|
Period 1
Adverse Event
|
2
|
0
|
Baseline Characteristics
Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor
Baseline characteristics by cohort
| Measure |
(1) Alcohol-responsive (EtOH+) Laryngeal Dystonia
n=23 Participants
For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group.
|
(2) Alcohol-responsive (EtOH+) Laryngeal Dystonia With Dystonic Tremor of Voice
n=29 Participants
For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group.
|
(3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
n=30 Participants
For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group.
|
(4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of Voice
n=26 Participants
For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=174 Participants
|
16 Participants
n=166 Participants
|
23 Participants
n=167 Participants
|
12 Participants
n=164 Participants
|
70 Participants
n=671 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=174 Participants
|
13 Participants
n=166 Participants
|
7 Participants
n=167 Participants
|
14 Participants
n=164 Participants
|
38 Participants
n=671 Participants
|
|
Age, Continuous
|
56.0 years
n=174 Participants
|
62.0 years
n=166 Participants
|
57.0 years
n=167 Participants
|
66.5 years
n=164 Participants
|
59.5 years
n=671 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=174 Participants
|
26 Participants
n=166 Participants
|
17 Participants
n=167 Participants
|
18 Participants
n=164 Participants
|
76 Participants
n=671 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=174 Participants
|
3 Participants
n=166 Participants
|
13 Participants
n=167 Participants
|
8 Participants
n=164 Participants
|
32 Participants
n=671 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=174 Participants
|
29 Participants
n=166 Participants
|
30 Participants
n=167 Participants
|
26 Participants
n=164 Participants
|
108 Participants
n=671 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
2 Participants
n=164 Participants
|
7 Participants
n=671 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=174 Participants
|
28 Participants
n=166 Participants
|
29 Participants
n=167 Participants
|
24 Participants
n=164 Participants
|
101 Participants
n=671 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Handedness
Right-handed
|
23 Participants
n=174 Participants
|
29 Participants
n=166 Participants
|
30 Participants
n=167 Participants
|
26 Participants
n=164 Participants
|
108 Participants
n=671 Participants
|
|
Handedness
Left-handed
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Monolingual native English Language
|
23 Participants
n=174 Participants
|
29 Participants
n=166 Participants
|
30 Participants
n=167 Participants
|
26 Participants
n=164 Participants
|
108 Participants
n=671 Participants
|
|
Cognitive function
≥ 26 points (normal cognitive function)
|
23 Participants
n=174 Participants
|
29 Participants
n=166 Participants
|
30 Participants
n=167 Participants
|
26 Participants
n=164 Participants
|
108 Participants
n=671 Participants
|
|
Cognitive function
< 26 points (impaired cognitive function)
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Dystonia phenotype
Adductor type
|
12 Participants
n=174 Participants
|
13 Participants
n=166 Participants
|
17 Participants
n=167 Participants
|
16 Participants
n=164 Participants
|
58 Participants
n=671 Participants
|
|
Dystonia phenotype
Abductor type
|
10 Participants
n=174 Participants
|
12 Participants
n=166 Participants
|
12 Participants
n=167 Participants
|
9 Participants
n=164 Participants
|
43 Participants
n=671 Participants
|
|
Dystonia phenotype
Mixed adductor and abductor type
|
1 Participants
n=174 Participants
|
4 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
7 Participants
n=671 Participants
|
|
Family history of dystonia
Familial type
|
3 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
8 Participants
n=671 Participants
|
|
Family history of dystonia
Sporadic type
|
20 Participants
n=174 Participants
|
27 Participants
n=166 Participants
|
28 Participants
n=167 Participants
|
25 Participants
n=164 Participants
|
100 Participants
n=671 Participants
|
|
Age of onset
|
38.0 years
n=174 Participants
|
50.0 years
n=166 Participants
|
43.5 years
n=167 Participants
|
46.5 years
n=164 Participants
|
44.0 years
n=671 Participants
|
|
Dystonia duration
|
13.0 years
n=174 Participants
|
13.0 years
n=166 Participants
|
11.0 years
n=167 Participants
|
13.4 years
n=164 Participants
|
13.0 years
n=671 Participants
|
|
Botulinum toxin treatment
|
20 Participants
n=174 Participants
|
26 Participants
n=166 Participants
|
26 Participants
n=167 Participants
|
21 Participants
n=164 Participants
|
93 Participants
n=671 Participants
|
|
Centrally acting medications
|
4 Participants
n=174 Participants
|
8 Participants
n=166 Participants
|
7 Participants
n=167 Participants
|
5 Participants
n=164 Participants
|
24 Participants
n=671 Participants
|
PRIMARY outcome
Timeframe: 40 min after drug or placebo administrationA combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity before and after drug vs. placebo intake. For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group.
Outcome measures
| Measure |
Alcohol-responsive (EtOH+) Laryngeal Dystonia
n=50 Participants
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
n=56 Participants
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-responsive Adductor Type of Laryngeal Dystonia
Laryngeal dystonia, adductor type
|
Alcohol-responsive Abductor Type of Laryngeal Dystonia
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive Adductor Type of Laryngeal Dystonia
Laryngeal dystonia, adductor type
|
Alcohol-non-responsive Abductor Type of Laryngeal Dystonia
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
Laryngeal dystonia
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of Voice
Laryngeal dystonia with dystonic tremor of voice
|
|---|---|---|---|---|---|---|---|---|
|
Symptom Severity
Sodium oxybate
|
28.0 score on a scale
Interval 21.0 to 35.0
|
18.6 score on a scale
Interval 12.0 to 25.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Symptom Severity
Placebo
|
14.2 score on a scale
Interval 7.2 to 21.2
|
12.3 score on a scale
Interval 5.7 to 19.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 40 min after drug or placebo administrationPopulation: Pre-specified to only report Alcohol-responsive (EtOH+) Laryngeal Dystonia Arm
Pre-specified to analysis based only on alcohol responsiveness (EtOH+). A combined clinician-objective and patient-subjective change in visual analog scale score (min-max 0-100, a higher score is the worse outcome) of symptom severity in EtOH+ patients.
Outcome measures
| Measure |
Alcohol-responsive (EtOH+) Laryngeal Dystonia
n=50 Participants
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-responsive Adductor Type of Laryngeal Dystonia
Laryngeal dystonia, adductor type
|
Alcohol-responsive Abductor Type of Laryngeal Dystonia
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive Adductor Type of Laryngeal Dystonia
Laryngeal dystonia, adductor type
|
Alcohol-non-responsive Abductor Type of Laryngeal Dystonia
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
Laryngeal dystonia
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of Voice
Laryngeal dystonia with dystonic tremor of voice
|
|---|---|---|---|---|---|---|---|---|
|
Minimum Treatment Efficacy
Symptom improvement ≥ 16%
|
40.81 percentage of symptom change
Interval 34.7 to 48.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Minimum Treatment Efficacy
Symptom improvement < 16%
|
4.76 percentage of symptom change
Interval 1.1 to 8.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 40 min after drug or placebo administrationA combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity before and after drug vs. placebo intake. EtOH+ and EtOH- were stratified based on phenotypical characteristics, including LD, LD with Dystonic Tremor of Voice, Abductor LD, Adductor LD.
Outcome measures
| Measure |
Alcohol-responsive (EtOH+) Laryngeal Dystonia
n=23 Participants
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
n=27 Participants
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-responsive Adductor Type of Laryngeal Dystonia
n=25 Participants
Laryngeal dystonia, adductor type
|
Alcohol-responsive Abductor Type of Laryngeal Dystonia
n=20 Participants
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive Adductor Type of Laryngeal Dystonia
n=33 Participants
Laryngeal dystonia, adductor type
|
Alcohol-non-responsive Abductor Type of Laryngeal Dystonia
n=21 Participants
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
n=30 Participants
Laryngeal dystonia
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of Voice
n=26 Participants
Laryngeal dystonia with dystonic tremor of voice
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Efficacy Dependent on LD Clinical Type
Placebo
|
18.07 score on a scale
Standard Error 3.99
|
10.85 score on a scale
Standard Error 5.90
|
13.59 score on a scale
Standard Error 6.07
|
13.10 score on a scale
Standard Error 4.62
|
13.07 score on a scale
Standard Error 1.54
|
11.32 score on a scale
Standard Error 2.83
|
10.34 score on a scale
Standard Error 1.94
|
14.47 score on a scale
Standard Error 1.93
|
|
Treatment Efficacy Dependent on LD Clinical Type
Sodium oxybate
|
24.65 score on a scale
Standard Error 4.45
|
30.54 score on a scale
Standard Error 4.29
|
31.70 score on a scale
Standard Error 5.08
|
24.85 score on a scale
Standard Error 3.92
|
21.36 score on a scale
Standard Error 2.86
|
14.96 score on a scale
Standard Error 4.04
|
18.30 score on a scale
Standard Error 3.07
|
18.96 score on a scale
Standard Error 3.49
|
SECONDARY outcome
Timeframe: 40 min to 5 hours after drug or placebo administrationPopulation: Pre-specified to only report based on alcohol-responsiveness (EtOH+, EtOH-)
The length of treatment efficacy in each EtOH+ and EtOH- group was assessed at 40, 180, and 300 min after drug vs. placebo intake compared to the baseline using a combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity. For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group.
Outcome measures
| Measure |
Alcohol-responsive (EtOH+) Laryngeal Dystonia
n=50 Participants
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
n=56 Participants
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-responsive Adductor Type of Laryngeal Dystonia
Laryngeal dystonia, adductor type
|
Alcohol-responsive Abductor Type of Laryngeal Dystonia
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive Adductor Type of Laryngeal Dystonia
Laryngeal dystonia, adductor type
|
Alcohol-non-responsive Abductor Type of Laryngeal Dystonia
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
Laryngeal dystonia
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of Voice
Laryngeal dystonia with dystonic tremor of voice
|
|---|---|---|---|---|---|---|---|---|
|
Length of Treatment Efficacy
Sodium oxybate: 40 min
|
28.0 score on a scale
Standard Error 3.06
|
18.60 score on a scale
Standard Error 2.31
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Length of Treatment Efficacy
Sodium oxybate: 180 min
|
18.63 score on a scale
Standard Error 3.36
|
12.67 score on a scale
Standard Error 2.40
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Length of Treatment Efficacy
Sodium oxybate: 300 min
|
15.47 score on a scale
Standard Error 4.32
|
8.33 score on a scale
Standard Error 1.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Length of Treatment Efficacy
Placebo: 40 min
|
14.23 score on a scale
Standard Error 3.71
|
12.34 score on a scale
Standard Error 1.39
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Length of Treatment Efficacy
Placebo: 180 min
|
9.26 score on a scale
Standard Error 3.61
|
9.31 score on a scale
Standard Error 1.99
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Length of Treatment Efficacy
Placebo: 300 min
|
10.30 score on a scale
Standard Error 3.15
|
8.16 score on a scale
Standard Error 1.84
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 40 min after drug or placebo administrationPopulation: Pre-specified to only report based on alcohol-responsiveness (EtOH+, EtOH-)
A combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity before and 40 min after drug vs. placebo intake. For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group.
Outcome measures
| Measure |
Alcohol-responsive (EtOH+) Laryngeal Dystonia
n=50 Participants
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
n=56 Participants
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-responsive Adductor Type of Laryngeal Dystonia
Laryngeal dystonia, adductor type
|
Alcohol-responsive Abductor Type of Laryngeal Dystonia
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive Adductor Type of Laryngeal Dystonia
Laryngeal dystonia, adductor type
|
Alcohol-non-responsive Abductor Type of Laryngeal Dystonia
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
Laryngeal dystonia
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of Voice
Laryngeal dystonia with dystonic tremor of voice
|
|---|---|---|---|---|---|---|---|---|
|
Relationship Between Alcohol-responsiveness of Symptoms and Drug-induced Symptom Improvement
Sodium oxybate
|
0.45 correlation coefficient
Interval 0.1 to 6.88
|
0.09 correlation coefficient
Interval -0.024 to 0.35
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relationship Between Alcohol-responsiveness of Symptoms and Drug-induced Symptom Improvement
Placebo
|
0.06 correlation coefficient
Interval -0.034 to 0.39
|
0.22 correlation coefficient
Interval -0.1 to 0.55
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 40 min after drug or placebo administrationPopulation: Pre-specified to only report based on alcohol-responsiveness (EtOH+, EtOH-)
A combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity before and 40 min after drug vs. placebo intake. For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group.
Outcome measures
| Measure |
Alcohol-responsive (EtOH+) Laryngeal Dystonia
n=50 Participants
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
n=56 Participants
Laryngeal dystonia with and without dystonic tremor of voice
|
Alcohol-responsive Adductor Type of Laryngeal Dystonia
Laryngeal dystonia, adductor type
|
Alcohol-responsive Abductor Type of Laryngeal Dystonia
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive Adductor Type of Laryngeal Dystonia
Laryngeal dystonia, adductor type
|
Alcohol-non-responsive Abductor Type of Laryngeal Dystonia
Laryngeal dystonia, abductor type
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
Laryngeal dystonia
|
Alcohol-non-responsive (EtOH-) Laryngeal Dystonia With Dystonic Tremor of Voice
Laryngeal dystonia with dystonic tremor of voice
|
|---|---|---|---|---|---|---|---|---|
|
Relationship Between Symptom Severity Change and Dystonia Clinical Characteristics
Sodium oxybate: duration
|
-0.17 correlation coefficient
Interval -0.51 to 0.16
|
0.10 correlation coefficient
Interval -0.26 to 0.49
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relationship Between Symptom Severity Change and Dystonia Clinical Characteristics
Placebo: duration
|
0.18 correlation coefficient
Interval -0.21 to 0.52
|
0.16 correlation coefficient
Interval -0.17 to 0.44
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relationship Between Symptom Severity Change and Dystonia Clinical Characteristics
Sodium oxybate: age of symptom onset
|
0.16 correlation coefficient
Interval -0.14 to 0.47
|
-0.15 correlation coefficient
Interval -0.43 to 0.18
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relationship Between Symptom Severity Change and Dystonia Clinical Characteristics
Placebo: age of symptom onset
|
-0.18 correlation coefficient
Interval -0.46 to 0.22
|
-0.09 correlation coefficient
Interval -0.4 to 0.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relationship Between Symptom Severity Change and Dystonia Clinical Characteristics
Sodium oxybate: baseline symptom severity
|
-0.05 correlation coefficient
Interval -0.31 to 0.2
|
-0.04 correlation coefficient
Interval -0.47 to 0.36
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relationship Between Symptom Severity Change and Dystonia Clinical Characteristics
Placebo: baseline symptom severity
|
0.24 correlation coefficient
Interval -0.2 to 0.58
|
-0.11 correlation coefficient
Interval -0.39 to 0.18
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Sodium Oxybate: Alcohol-responsive (EtOH+) Laryngeal Dystonia
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo: Alcohol-responsive (EtOH+) Laryngeal Dystonia
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sodium Oxybate: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sodium Oxybate: Alcohol-responsive (EtOH+) Laryngeal Dystonia
n=50 participants at risk
For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group.
|
Placebo: Alcohol-responsive (EtOH+) Laryngeal Dystonia
n=50 participants at risk
For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group.
|
Sodium Oxybate: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
n=56 participants at risk
For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group.
|
Placebo: Alcohol-non-responsive (EtOH-) Laryngeal Dystonia
n=56 participants at risk
For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia and (4) Alcohol-non-responsive (EtOH-) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH- group.
|
|---|---|---|---|---|
|
Nervous system disorders
Mild Dizziness/ lightheadedness/unsteadiness/clumsiness
|
48.0%
24/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
8.0%
4/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
48.2%
27/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
14.3%
8/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Mild Blurred vision
|
4.0%
2/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
2.0%
1/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
7.1%
4/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Mild Headache
|
8.0%
4/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
4.0%
2/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
5.4%
3/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
3.6%
2/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Mild Trouble concentrating
|
6.0%
3/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
1.8%
1/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
1.8%
1/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Mild Confusion
|
2.0%
1/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Mild Restlessness
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
1.8%
1/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Mild Disorientation
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
1.8%
1/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
1.8%
1/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Mild Depression
|
2.0%
1/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Mild Feeling hangover
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
1.8%
1/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Mild Nervousness
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
2.0%
1/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Mild Lethargy
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
1.8%
1/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Gastrointestinal disorders
Mild Nausea
|
2.0%
1/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
14.3%
8/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
1.8%
1/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Gastrointestinal disorders
Mild Dry mouth
|
6.0%
3/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
6.0%
3/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
5.4%
3/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
1.8%
1/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Gastrointestinal disorders
Mild Vomiting
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
3.6%
2/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Gastrointestinal disorders
Mild Diarrhea
|
2.0%
1/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Gastrointestinal disorders
Mild Stomach pain
|
2.0%
1/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Mild Daytime sleepiness
|
20.0%
10/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
6.0%
3/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
14.3%
8/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Nervous system disorders
Moderate Dizziness/ lightheadedness/unsteadiness/clumsiness
|
2.0%
1/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
3.6%
2/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
|
Gastrointestinal disorders
Moderate Nausea
|
2.0%
1/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/50 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
0.00%
0/56 • 5 hours and a 24-hour follow-up
Safety was documented as a change from baseline in vital signs (blood pressure, pulse rate), cognitive function (MoCA), suicidality (C-SSRS), and daytime sleepiness (Epworth sleepiness scale). Adverse events were assessed using a structured side effects questionnaire and unstructured patient reporting (unprompted self-reporting by patients) as none, mild, moderate, or severe. Pre-specified to report adverse events by alcohol responsiveness and intervention only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place