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NCT02901431 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD)
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 339
- Enrollment target
NCT02901431: Clinical Trial Phase 2 study, sponsored by Hoffmann-La Roche.
NCT02901431 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 339 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (155% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02901431, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 339 participants
- Enrollment target
Study Summary
For participants enrolled prior to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of balovaptan in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient \[IQ\] greater than or equal to \[\>=\] 70). For participants enrolled according to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, parallel group, placebo-controlled, 2-arm study with participants assigned either to a 10 milligram (mg) or equivalent dose of balovaptan, or placebo. All other study parameters remained as stated above. There are three parts to this study: PK Part (Study part 1) included up to 8 weeks of treatment, Main Treatment Part (Study part 2) included 24 week of treatment, and the Open Label Extension Part (Study part 3) included Week 24 to Week 76 of treatment. All participants that completed the 24-week treatment period were eligible to participate in an optional 52-week open-label extension (OLE) during which they received balovaptan treatment.
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 RO5285119
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 339 participants |
| Start Date | 2016-11-21 |
| Est. Completion | 2020-06-30 |
| Phase | Phase 2 |
Why NCT02901431 stopped before completion
NCT02901431 is an interventional study that assigns participants to a tested intervention. The registered 339 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (155% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02901431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02901431 about?
NCT02901431 is a clinical study titled "A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD)". For participants enrolled prior to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of balovaptan in children and adolescents aged 5-17 years with ...
What is the current status of trial NCT02901431?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 339 participants. The study started on 2016-11-21. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT02901431?
The interventions under investigation include: Placebo (DRUG), RO5285119 (DRUG).
Who is sponsoring clinical trial NCT02901431?
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 NCT02901431's enrollment target sits among peer trials
339 140th of 2000 higher than 1,861 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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