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NCT03504917 · ClinicalTrials.gov registry record · Phase 3
A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 322
- Enrollment target
NCT03504917: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03504917 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 322 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03504917, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 322 participants
- Enrollment target
Study Summary
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).
Primary Outcome
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 re
Interventions
- DRUG Placebo
- DRUG Balovaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2018-08-08 |
| Est. Completion | 2020-07-01 |
| Phase | Phase 3 |
Why NCT03504917 stopped before completion
NCT03504917 is an interventional study that assigns participants to a tested intervention. The registered 322 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03504917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03504917 about?
NCT03504917 is a clinical study titled "A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension". 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).
What is the current status of trial NCT03504917?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 322 participants. The study started on 2018-08-08. Estimated completion is 2020-07-01.
What interventions are being tested in trial NCT03504917?
The interventions under investigation include: Placebo (DRUG), Balovaptan (DRUG).
Who is sponsoring clinical trial NCT03504917?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03504917's enrollment target sits among peer trials
322 1081st of 2000 higher than 920 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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