Trial · NCT04299464
A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD)
NCT04299464, Phase 2, Completed, Hoffmann-La Roche; results first posted 2025-01-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD). Trials, record NCT04299464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04299464
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD)
- NCT number
- NCT04299464
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 104 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Autism Spectrum Disorder (ASD)
- Interventions
- Placebo, RO7017773
- First posted
- 2020-03-06
- Last updated
- 2025-01-28
- Other registries' IDs
- eudract:2019-003524-20
- Results first posted
- 2025-01-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in the Adaptive Behavior Composite (ABC) Score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) | Baseline to Week 12 | Vineland-3 is a semi-structured interview that measures an individual's adaptive behavior across 3 domains: Communication, Socialization, and Daily Living skills. Each domain is composed of 3 subdomains. Subdomain raw score is based on item responses (3-point scale: 0=never present; 1=sometimes present; 2=usually present) and is calculated for each subdomain of the three main domains as the sum of the scores for each item within the subdomain. Raw scores of the 9 subdomains are used to derive Growth Scale Values (GSVs; range = 10-197). A conversion table for mapping raw scores to GSV scores is found in Appendix 3, Table B.2 in the Vineland-3 manual (Sparrow et al. 2016). GSV is a person-ability score used to track an individual's progress. Vineland-3 ABC Composite GSV score is calculated as the mean GSV score (summing the 9 GSV subdomain scores and dividing by 9; Vineland-3 ABC Composite GSV scores can range from 10-154). A higher score indicates better adaptive functioning. |
| Secondary | Number of Participants With at Least One Adverse Events (AEs) | Up to Week 18 | An AE is an untoward medical occurrence in a participant administered a pharmaceutical product and regardless of the causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. |
| Secondary | Number of Participants With at Least One Serious Adverse Events (SAEs) | Up to Week 18 | An AE is an untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to investigational product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. |
| Secondary | Number of Participants Discontinuing Treatment Due to AEs | Day 1 up to Week 12 | An AE is an untoward medical occurrence in a participant administered a pharmaceutical product and regardless of the causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. |
| Secondary | Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behaviour as Measured Using the Columbia-Suicide-Severity Rating Scale (C-SSRS) | Baseline up to Week 18 | C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. |
| Secondary | Change From Baseline in Karolinska Sleepiness Scale (KSS) Score for Assessing Daytime Sleepiness | Baseline (Day 1 Predose), 3-4 hours post-dose on Day 1, Predose and 3-4 hours post-dose on Days 14, 42, and 84 | The KSS measures the subjective level of sleepiness at a particular time during the day. On this scale, participants (or support persons for adolescents aged 15 to 17 years and low-functioning participants) indicate which level best reflects the psycho-physical state experienced in the last 5 minutes. The KSS is a 9-point scale (1=extremely alert, 9=very sleepy, great effort to keep awake, fighting sleep). A decrease in KSS score or negative change from baseline indicate an improvement in sleepiness. |
| Secondary | Change From Baseline in Epworth Sleepiness Scale Score (ESS) for Assessing Daytime Sleepiness | Baseline (Day 1), Days 14, 42, and 84 | The ESS is a brief, self-administered eight-item questionnaire that measures daytime sleepiness in adults. Participants were asked to rate on a scale of 0-3 the chances that, "over the past month" and "since last visit", he/she would have dozed in eight specific situations that are commonly met in daily life (0 = would never doze and 3 = high chance of dozing). The ESS score is the sum of eight item-scores and can range from 0 to 24. A lower ESS score or a negative change from baseline score indicates an improvement in daytime sleepiness. |
| Secondary | Change From Baseline ESS Score for Children and Adolescents (ESS-CHAD) for Assessing Daytime Sleepiness | Baseline (Day 1), Days 14, 42, 63, and 84 | The ESS-CHAD is a brief, support person-administered eight-item questionnaire that measures daytime sleepiness in children and adolescents. Each item asked the support persons of adolescents and participants with an IQ score \<70 to rate on a scale of 0-3 the chances that "Over the past month," and "since last visit", "your child" would have dozed in eight specific situations that are commonly met in daily life ( 0 to 3 where 0 = would never doze and 3 = high chance of dozing). The ESS score is the sum of eight item scores and can range from 0 to 24. A lower ESS score or negative change from baseline score indicates an improvement in daytime sleepiness. |
| Secondary | Number of Participants With Daytime Sleepiness Assessed Using Sudden Onset of Sleep Questionnaire | Baseline (Day 1), Days 7, 14, 42, 63, and 84 | A sleep questionnaire was developed specifically for this study. Each participant (or support person for adolescents aged 15 to 17 years and for low-functioning participants) was asked to answer a series of 8 questions. The questions and their corresponding responses are as follows: a. Have you ever fallen asleep or have you been likely to fall asleep during your waking time? (Yes/No); b. Was this episode? (Gradual with awareness/Sudden and unpredictable/Sudden with awareness); c. Of the recent episode, how often does this occur? (Every day/Less frequently/Once a week/Other); d. Do you feel worried about falling asleep during the day? (Yes/No); e. Did the episode (or episodes) disrupt your daily activities? (Considerably/Marginally/No); f. Did this episode (or episodes) disrupt your social life (Considerably/Marginally/No); g. In the case of such an episode, was awakening? (Difficult/Easy/Normal). Categories with non-zero values are only reported here. |
| Secondary | Change From Baseline to Week 12 in Behavior/Symptoms as Measured by All Domains of the Repetitive Behavior Scale-Revised (RBS-R) Score | Baseline to Week 12 | The RBS-R is a 43-item informant-based questionnaire, assessing the variety of restricted and repetitive behaviors (RRBs) in individuals with ASD. The scale is grouped into six subscales: Stereotyped, Self-Injurious, Compulsive, Ritualistic, Sameness, and Restricted Behaviors. For each item, behaviors are rated on a 4-point scale: 0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem. A total RBS-R score is calculated as the sum of the scores for the 43 items. The total score ranges from 0 to 129 and higher scores are indicative of more severe RRBs. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in the Adaptive Behavior Composite (ABC) Score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) | Baseline to Week 12 | Efficacy population included all participants who gave informed consent, were randomized, and received at least one dose of double-blind study medication. Overall number analyzed is the number of participants with data available for analysis | score on a scale | MEAN |
| SECONDARY | Number of Participants With at Least One Adverse Events (AEs) | Up to Week 18 | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With at Least One Serious Adverse Events (SAEs) | Up to Week 18 | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Discontinuing Treatment Due to AEs | Day 1 up to Week 12 | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behaviour as Measured Using the Columbia-Suicide-Severity Rating Scale (C-SSRS) | Baseline up to Week 18 | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Karolinska Sleepiness Scale (KSS) Score for Assessing Daytime Sleepiness | Baseline (Day 1 Predose), 3-4 hours post-dose on Day 1, Predose and 3-4 hours post-dose on Days 14, 42, and 84 | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Epworth Sleepiness Scale Score (ESS) for Assessing Daytime Sleepiness | Baseline (Day 1), Days 14, 42, and 84 | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline ESS Score for Children and Adolescents (ESS-CHAD) for Assessing Daytime Sleepiness | Baseline (Day 1), Days 14, 42, 63, and 84 | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Daytime Sleepiness Assessed Using Sudden Onset of Sleep Questionnaire | Baseline (Day 1), Days 7, 14, 42, 63, and 84 | Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Number analyzed is the number of participants with data available for analysis at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 12 in Behavior/Symptoms as Measured by All Domains of the Repetitive Behavior Scale-Revised (RBS-R) Score | Baseline to Week 12 | Efficacy population included all participants who gave informed consent, were randomized, and received at least one dose of double-blind study medication. Overall number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group392
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in the Adaptive Behavior Composite (ABC) Score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) | Placebo | 3.250 | 80% Confidence Interval 2.011 to 4.490 | score on a scale | |
| Change From Baseline to Week 12 in the Adaptive Behavior Composite (ABC) Score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) | Alogabat 20 mg | 2.819 | 80% Confidence Interval 1.469 to 4.169 | score on a scale | |
| Change From Baseline to Week 12 in the Adaptive Behavior Composite (ABC) Score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) | Alogabat 60 mg | 2.807 | 80% Confidence Interval 1.499 to 4.115 | score on a scale | |
| Number of Participants With at Least One Adverse Events (AEs) | Placebo | 24 | Participants | ||
| Number of Participants With at Least One Adverse Events (AEs) | Alogabat 20 mg | 22 | Participants | ||
| Number of Participants With at Least One Adverse Events (AEs) | Alogabat 60 mg | 22 | Participants | ||
| Number of Participants With at Least One Serious Adverse Events (SAEs) | Placebo | 0 | Participants | ||
| Number of Participants With at Least One Serious Adverse Events (SAEs) | Alogabat 20 mg | 0 | Participants | ||
| Number of Participants With at Least One Serious Adverse Events (SAEs) | Alogabat 60 mg | 0 | Participants | ||
| Number of Participants Discontinuing Treatment Due to AEs | Placebo | 1 | Participants |
1 to 10 of 392Source ClinicalTrials.gov
See all 392 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 34 | |
| Overall Study | STARTED | Alogabat 20 mg | 34 | |
| Overall Study | STARTED | Alogabat 60 mg | 36 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | COMPLETED | Alogabat 20 mg | 30 | |
| Overall Study | COMPLETED | Alogabat 60 mg | 29 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Alogabat 20 mg | 4 | |
| Overall Study | NOT COMPLETED | Alogabat 60 mg | 7 |
Source ClinicalTrials.gov
Adverse events51
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Placebo | 0 | 34 | 0 |
| other | Fatigue | General disorders | Alogabat 20 mg | 2 | 34 | 5 |
| other | Fatigue | General disorders | Alogabat 60 mg | 3 | 36 | 4 |
| other | Gastroenteritis | Infections and infestations | Placebo | 0 | 34 | 0 |
| other | Gastroenteritis | Infections and infestations | Alogabat 20 mg | 2 | 34 | 2 |
| other | Gastroenteritis | Infections and infestations | Alogabat 60 mg | 1 | 36 | 1 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 1 | 34 | 1 |
| other | Nasopharyngitis | Infections and infestations | Alogabat 20 mg | 3 | 34 | 3 |
| other | Nasopharyngitis | Infections and infestations | Alogabat 60 mg | 1 | 36 | 1 |
| other | Rhinitis | Infections and infestations | Placebo | 2 | 34 | 4 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 34 |
| Total, all-cause mortality | Alogabat 20 mg | 0 | 34 |
| Total, all-cause mortality | Alogabat 60 mg | 0 | 36 |
| Total, other adverse events | Placebo | 16 | 34 |
| Total, other adverse events | Alogabat 20 mg | 20 | 34 |
| Total, other adverse events | Alogabat 60 mg | 17 | 36 |
| Total, serious adverse events | Placebo | 0 | 34 |
| Total, serious adverse events | Alogabat 20 mg | 0 | 34 |
| Total, serious adverse events | Alogabat 60 mg | 0 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04299464
GET https://conductscience.org/api/trials/v1/NCT04299464/results?page=2