A Phase 3 interventional study of Balovaptan and Placebo in Autism Spectrum Disorder, sponsored by Hoffmann-La Roche. Terminated at 51 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-27.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 322 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Balovaptan
Drug: Placebo
Participants will receive 10 mg of oral administration balovaptan once a day (QD).
Participants will receive matching placebo.
Change From Baseline at Week 24 on the Vineland Adaptive Behavior Scales (Vineland-II) Two-domain Composite (2DC) Score.
Vineland™-II Adaptive Behavior Scales 2-Domain Composite (2DC) Score is defined as mean of the Communication domain standard score \& Socialization domain standard score. If any of the 2 individual domain standard scores is missing 2DC score is not computed. Vineland™-II is an instrument that measures communication, daily living skills, socialization, motor skills and maladaptive behavior of individuals with developmental disabilities. Survey Interview Form will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning.
Time frame: Week 24
Change From Baseline at Week 12 on the Vineland-II 2DC Score
Vineland™-II Adaptive Behavior Scales 2-Domain Composite (2DC) Score is defined as mean of the Communication domain standard score \& Socialization domain standard score. If any of the 2 individual domain standard scores is missing 2DC score is not computed. Vineland™-II is an instrument that measures communication, daily living skills, socialization, motor skills and maladaptive behavior of individuals with developmental disabilities. Survey Interview Form will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning.
Time frame: Week 12
Change From Baseline at Weeks 12 and 24 in the Pediatric Quality of Life (PedsQL) Inventory Generic Core Scales, Version 4.0, on Summary and Total Scores
The Pediatric Quality of Life Inventory PedsQL™4.0 Generic Core Scale assessment consists of a 23 item questionnaire encompassing 4 core scale domains: Physical Functioning (8 items); Emotional Functioning (5 items); Social Functioning (5 items); and School Functioning (5 items). Items are scored on a 5 point Likert-type response scale (0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). Once scored, items will be reverse scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), so that higher scores indicate better health-related quality of life.
Time frame: Weeks 12 and 24
Change From Baseline at Weeks 12 and 24 in the Vineland-II Adaptive Behavior Composite Standard Score
The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning. Only descriptive statistics presented instead of the planned estimated due to the early discontinuation of the study due to futility.
Time frame: Weeks 12 and 24
Change From Baseline at Week 12 and 24 on the Vineland-II Socialization Domain Standard Score
The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning. Only descriptive statistics presented instead of the planned estimand due to the early discontinuation of the study due to futility.
Time frame: Baseline, Weeks 12 and 24
Change From Baseline at Weeks 12 and 24 on the Vineland-II Communication Domain Standard Score
The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning.
Time frame: Weeks 12 and 24
Change From Baseline at Weeks 12 and 24 on the Vineland-II Daily Living Skills Domain Standard Score
The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning. Only descriptive statistics presented instead of the planned estimated due to the early discontinuation of the study due to futility.
Time frame: Weeks 12 and 24
Change From Baseline in Severity of Clinical Impressions as Measured by Clinical Global Impression-Severity (CGI-S)
The CGI-S reflects the rater's impression of the subject's current autism severity on a 7-point scale ranging from no symptoms (1) to very severe symptoms (7). Changes in CGI-S score were calculated as increase or decrease in absolute CGI-S scores between Baseline and Weeks 12 and 24. Percentage of participants reported for each change in score from baseline.
Time frame: Weeks 12 and 24
Improvements in Clinical Impressions, as Measured by Clinical Global Impression-Improvement (CGI-I)
This is a 7-point Likert scale that assesses improvement of the patient's condition. Scores range from the worst score of 7 (Very much worse) to the best score of 1 (Very much improved). Lower scores are better on this scale, and indicate greater improvement. Percentage of participants reported for each score.
Time frame: Weeks 12 and 24
Change From Baseline at Weeks 12 and 24 in the Hamilton Anxiety Rating Scale (HAM-A) Total and Domain Scores
The HAM-A is a 14-item, rater administered interview, assessing the severity of anxiety symptoms during the past 7 days. Seven items assess psychic anxiety and seven assess somatic anxiety. Each item utilizes a 5-point symptom severity response scale, ranging from none (0) to very severe (4). A total score is calculated that ranges from 0 to 56; higher scores are indicative of more severe anxiety.
Time frame: Weeks 12 and 24
Proportion of Subjects With a >=6-point Improvement in Vineland-II 2DC Score
The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning All participants who have an improvement of at least 6 points are included in the \>=6 score threshold
Time frame: Weeks 12 and 24
Percentage of Participants With Adverse Events
According to the ICH guideline for Good Clinical Practice, an adverse event is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The Blinded Treatment Period continued for 24 weeks, Open Label Extension (OLE) Treatment Period continued up to 2 years. The study was pre-maturely terminated, therefore did not reach the planned end date.
Time frame: Week 24 and Up to Approximately 2 Years
322 Participants were randomized. 1 Participants did not receive the treatment and in the ITT Population, 321 participants received at least one dose of the study treatment. The Study was discontinued early before the planned sample size was reached.
| Milestone | Balovaptan | Placebo |
|---|---|---|
| Started | 163 | 158 |
| Completed | 103 | 102 |
| Not completed | 60 | 56 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 12 | 9 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 4 |
| Withdrew: Adverse event | 4 | 4 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Unable due to leaving the study site, non-interest, withdrawal, and a partner inability | 1 | 3 |
| Withdrew: Study terminated by sponsor | 39 | 34 |
| Withdrew: Non-compliance with study drug | 0 | 1 |
| Milestone | Balovaptan | Placebo |
|---|---|---|
| Started | 100 | 97 |
| Completed | 0 | 0 |
| Not completed | 100 | 97 |
| Withdrew: The participant left the study site | 0 | 1 |
| Withdrew: Withdrawal by subject | 8 | 2 |
| Withdrew: Lost to follow-up | 1 | 4 |
| Withdrew: Lack of efficacy | 3 | 1 |
| Withdrew: Adverse event | 7 | 0 |
| Withdrew: Non-compliance with study drug | 0 | 1 |
| Withdrew: Study terminated by sponsor | 81 | 88 |
Vineland™-II Adaptive Behavior Scales 2-Domain Composite (2DC) Score is defined as mean of the Communication domain standard score \& Socialization domain standard score. If any of the 2 individual domain standard scores is missing 2DC score is not computed. Vineland™-II is an instrument that measures communication, daily living skills, socialization, motor skills and maladaptive behavior of individuals with developmental disabilities. Survey Interview Form will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning.
| Score | Balovaptan | Placebo |
|---|---|---|
| Change From Baseline at Week 24 on the Vineland Adaptive Behavior Scales (Vineland-II) Two-domain Composite (2DC) Score. | 4.56 ± 10.85 | 6.83 ± 12.18 |
Vineland™-II Adaptive Behavior Scales 2-Domain Composite (2DC) Score is defined as mean of the Communication domain standard score \& Socialization domain standard score. If any of the 2 individual domain standard scores is missing 2DC score is not computed. Vineland™-II is an instrument that measures communication, daily living skills, socialization, motor skills and maladaptive behavior of individuals with developmental disabilities. Survey Interview Form will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning.
| Score | Balovaptan | Placebo |
|---|---|---|
| Change From Baseline at Week 12 on the Vineland-II 2DC Score | 3.47 ± 10.00 | 4.85 ± 12.64 |
The Pediatric Quality of Life Inventory PedsQL™4.0 Generic Core Scale assessment consists of a 23 item questionnaire encompassing 4 core scale domains: Physical Functioning (8 items); Emotional Functioning (5 items); Social Functioning (5 items); and School Functioning (5 items). Items are scored on a 5 point Likert-type response scale (0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). Once scored, items will be reverse scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), so that higher scores indicate better health-related quality of life.
| Score | Balovaptan | Placebo |
|---|---|---|
| Total Score at Week 12 | 4.1 ± 11.2 | 5.0 ± 10.2 |
| Psychosocial Health Summary Score at Week 12 | 4.9 ± 13.2 | 5.5 ± 12.7 |
| Physical Health Summary Score at Week 12 | 2.5 ± 13.3 | 4.3 ± 12.3 |
| Total Score at Week 24 | 8.0 ± 13.7 | 6.0 ± 11.6 |
| Psychosocial Health Summary Score at Week 24 | 10.0 ± 15.4 | 6.9 ± 14.1 |
| Physical Health Summary Score at Week 24 | 4.3 ± 15.5 | 4.4 ± 14.5 |
The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning. Only descriptive statistics presented instead of the planned estimated due to the early discontinuation of the study due to futility.
| Score | Balovaptan | Placebo |
|---|---|---|
| Week 12 | 2.87 ± 6.99 | 3.99 ± 10.01 |
| Week 24 | 4.32 ± 8.43 | 5.26 ± 9.69 |
The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning. Only descriptive statistics presented instead of the planned estimand due to the early discontinuation of the study due to futility.
| Score | Balovaptan | Placebo |
|---|---|---|
| 12 Week | 3.63 ± 11.58 | 5.26 ± 12.71 |
| 24 Week | 5.54 ± 13.54 | 6.86 ± 11.75 |
The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning.
| Score | Balovaptan | Placebo |
|---|---|---|
| Week 12 | 3.30 ± 13.74 | 4.44 ± 16.58 |
| Week 24 | 3.59 ± 16.30 | 6.81 ± 17.50 |
The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning. Only descriptive statistics presented instead of the planned estimated due to the early discontinuation of the study due to futility.
| Score | Balovaptan | Placebo |
|---|---|---|
| Week 12 | 2.93 ± 8.44 | 2.74 ± 9.20 |
| Week 24 | 5.14 ± 9.34 | 3.02 ± 9.04 |
The CGI-S reflects the rater's impression of the subject's current autism severity on a 7-point scale ranging from no symptoms (1) to very severe symptoms (7). Changes in CGI-S score were calculated as increase or decrease in absolute CGI-S scores between Baseline and Weeks 12 and 24. Percentage of participants reported for each change in score from baseline.
| Percentage of Participants | Balovaptan | Placebo |
|---|---|---|
| Week 12 -3 | 0 | 0 |
| Week 12 -2 | 2.0 | 2.2 |
| Week 12 -1 | 21.8 | 25.0 |
| Week 12 0 | 74.8 | 72.1 |
| Week 12 +1 | 0.7 | 0.7 |
| Week 12 +2 | 0.7 | 0 |
| Week 12 +3 | 0 | 0 |
| Week 24 -3 | 0 | 1.0 |
| Week 24 -2 | 5.5 | 10.0 |
| Week 24 -1 | 27.5 | 20.0 |
| Week 24 0 | 66.1 | 68.0 |
| Week 24 +1 | 0.9 | 1.0 |
| Week 24 +2 | 0 | 0 |
| Week 24 +3 | 0 | 0 |
This is a 7-point Likert scale that assesses improvement of the patient's condition. Scores range from the worst score of 7 (Very much worse) to the best score of 1 (Very much improved). Lower scores are better on this scale, and indicate greater improvement. Percentage of participants reported for each score.
| Percentage of Participants | Balovaptan | Placebo |
|---|---|---|
| Week 12 1 | 0 | 0 |
| Week 12 2 | 10.1 | 14.7 |
| Week 12 3 | 36.5 | 43.4 |
| Week 12 4 | 50.0 | 41.2 |
| Week 12 5 | 3.4 | 0.7 |
| Week 12 6 | 0 | 0 |
| Week 12 7 | 0 | 0 |
| Week 24 1 | 0 | 2.0 |
| Week 24 2 | 15.6 | 24.0 |
| Week 24 3 | 44.0 | 40.0 |
| Week 24 4 | 38.5 | 33.0 |
| Week 24 5 | 0.9 | 1.0 |
| Week 24 6 | 0.9 | 0 |
| Week 24 7 | 0 | 0 |
The HAM-A is a 14-item, rater administered interview, assessing the severity of anxiety symptoms during the past 7 days. Seven items assess psychic anxiety and seven assess somatic anxiety. Each item utilizes a 5-point symptom severity response scale, ranging from none (0) to very severe (4). A total score is calculated that ranges from 0 to 56; higher scores are indicative of more severe anxiety.
| Score | Balovaptan | Placebo |
|---|---|---|
| Week 12 Total | -1.7 ± 4.9 | -2.8 ± 4.4 |
| Week 12 Psychic Anxiety Subscale | -1.3 ± 3.5 | -1.8 ± 3.2 |
| Week 12 Somatic Anxiety Subscale | -0.4 ± 2.4 | -1.0 ± 2.5 |
| Week 24 Total | -2.7 ± 4.5 | -2.8 ± 5.7 |
| Week 24 Psychic Anxiety Subscale | -2.1 ± 3.4 | -1.8 ± 3.9 |
| Week 24 Somatic Anxiety Subscale | -0.6 ± 2.2 | -0.1 ± 2.9 |
The Vineland-II is an instrument that measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a subject's reliable study partner in this study, during which the rater or clinician will ask to the study partner open ended questions relating to the subject's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the Vineland-II Adaptive Behavior Composite score. Standardized scores on the Adaptive behavior composite range from 20-160 with higher scores indicating better functioning All participants who have an improvement of at least 6 points are included in the \>=6 score threshold
| Percentage of Participants | Balovaptan | Placebo |
|---|---|---|
| Week 12 >=6 | 34.4 | 42.1 |
| Week 24 >=6 | 43 | 48.4 |
According to the ICH guideline for Good Clinical Practice, an adverse event is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The Blinded Treatment Period continued for 24 weeks, Open Label Extension (OLE) Treatment Period continued up to 2 years. The study was pre-maturely terminated, therefore did not reach the planned end date.
| Percentage of Participants | Balovaptan Treatment | Placebo Treatment | Balovaptan OLE | Placebo OLE |
|---|---|---|---|---|
| Percentage of Participants With Adverse Events | 60.1 | 65.8 | 59.0 | 55.7 |
Collected over From baseline to the end of Safety Period, up to 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Balovaptan in Blinded Treatment Period | 0/163 (0%) | 2/163 (1.2%) | 49/163 (30.1%) |
| Placebo Blinded Treatment Period | 1/158 (0.6%) | 5/158 (3.2%) | 59/158 (37.3%) |
| Balovaptan in Open Label Extension Treatment Period | 0/100 (0%) | 0/100 (0%) | 28/100 (28%) |
| Placebo in Open Label Extension Treatment Period | 0/97 (0%) | 2/97 (2.1%) | 30/97 (30.9%) |
| Event | Balovaptan in Blinded Treatment Period | Placebo Blinded Treatment Period | Balovaptan in Open Label Extension Treatment Period | Placebo in Open Label Extension Treatment Period |
|---|---|---|---|---|
| Urinary tract infectionInfections and infestations | 0/163 | 0/158 | 0/100 | 1/97 |
| Pharyngitis streptococcalInfections and infestations | 0/163 | 0/158 | 0/100 | 1/97 |
| SepsisInfections and infestations | 0/163 | 0/158 | 0/100 | 1/97 |
| Femur fractureInjury, poisoning and procedural complications | 0/163 | 0/158 | 0/100 | 1/97 |
| Panic disorderPsychiatric disorders | 0/163 | 1/158 | 0/100 | 0/97 |
| ColitisGastrointestinal disorders | 0/163 | 1/158 | 0/100 | 0/97 |
| Abscess limbInfections and infestations | 0/163 | 1/158 | 0/100 | 0/97 |
| UrosepsisInfections and infestations | 0/163 | 1/158 | 0/100 | 0/97 |
| Completed suicidePsychiatric disorders | 0/163 | 1/158 | 0/100 | 0/97 |
| Suicidal ideationPsychiatric disorders | 1/163 | 1/158 | 0/100 | 0/97 |
| Event | Balovaptan in Blinded Treatment Period | Placebo Blinded Treatment Period | Balovaptan in Open Label Extension Treatment Period | Placebo in Open Label Extension Treatment Period |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 14/163 | 19/158 | 7/100 | 4/97 |
| HeadacheNervous system disorders | 8/163 | 7/158 | 5/100 | 10/97 |
| DiarrhoeaGastrointestinal disorders | 11/163 | 14/158 | 5/100 | 4/97 |
| AnxietyPsychiatric disorders | 8/163 | 7/158 | 8/100 | 3/97 |
| Upper respiratory tract infectionInfections and infestations | 10/163 | 9/158 | 6/100 | 7/97 |
| DizzinessNervous system disorders | 2/163 | 10/158 | 2/100 | 1/97 |
| NauseaGastrointestinal disorders | 4/163 | 7/158 | 1/100 | 5/97 |
| GastroenteritisInfections and infestations | 2/163 | 0/158 | 1/100 | 5/97 |
| InsomniaPsychiatric disorders | 5/163 | 8/158 | 3/100 | 3/97 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 5/163 | 8/158 | 0/100 | 3/97 |
| Age, Continuous(Years) | Balovaptan | Placebo | Total |
|---|---|---|---|
| Mean | 27.6 ± 9.7 | 27.6 ± 9.8 | 27.6 ± 9.7 |
| Sex: Female, Male(Participants) | Balovaptan | Placebo | Total |
|---|---|---|---|
| Female | 35 | 30 | 65 |
| Male | 128 | 128 | 256 |
| Ethnicity (NIH/OMB)(Participants) | Balovaptan | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 15 | 13 | 28 |
| Not Hispanic or Latino | 145 | 142 | 287 |
| Unknown or Not Reported | 3 | 3 | 6 |
| Race (NIH/OMB)(Participants) | Balovaptan | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 3 | 5 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 6 | 15 |
| White | 143 | 140 | 283 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 5 | 4 | 9 |
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