# A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD)

> **NCT02901431** · PHASE2 · TERMINATED · sponsor: **Hoffmann-La Roche** · enrollment: 339 (actual)

## Conditions studied

- Autism Spectrum Disorder

## Interventions

- **DRUG:** Placebo
- **DRUG:** RO5285119

## Key facts

- **NCT ID:** NCT02901431
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2016-11-21
- **Primary completion:** 2020-04-15
- **Final completion:** 2020-06-30
- **Target enrollment:** 339 (ACTUAL)
- **Why stopped:** The 24-week analysis indicated no clinical or statistical benefit for the primary endpoint for the overall study population. No new safety concerns identified.
- **Last updated:** 2021-02-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02901431

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02901431, "A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD)". Retrieved via MORVS 2026-10-06 from https://api.morvs.ai/clinical/NCT02901431. Licensed CC0.

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