Trials / Terminated
TerminatedNCT03504917
A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 322 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Balovaptan | Participants will receive 10 mg of oral administration balovaptan once a day (QD). |
| DRUG | Placebo | Participants will receive matching placebo. |
Timeline
- Start date
- 2018-08-08
- Primary completion
- 2020-03-04
- Completion
- 2020-07-01
- First posted
- 2018-04-20
- Last updated
- 2021-10-27
- Results posted
- 2021-05-07
Locations
51 sites across 6 countries: United States, Canada, France, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03504917. Inclusion in this directory is not an endorsement.