# A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

> **NCT03504917** · PHASE3 · TERMINATED · sponsor: **Hoffmann-La Roche** · enrollment: 322 (actual)

## Conditions studied

- Autism Spectrum Disorder

## Interventions

- **DRUG:** Balovaptan
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT03504917
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2018-08-08
- **Primary completion:** 2020-03-04
- **Final completion:** 2020-07-01
- **Target enrollment:** 322 (ACTUAL)
- **Why stopped:** A futility analysis assessed that the study is highly unlikely to meet the pre-defined primary objective of the study. No new safety concerns were identified.
- **Last updated:** 2021-10-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03504917

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03504917, "A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension". Retrieved via AI Analytics 2026-05-30 from https://api.ai-analytics.org/clinical/NCT03504917. Licensed CC0.

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