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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 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 339 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02901431
The ClinicalTrials.gov registry entry for NCT02901431 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 339 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02901431 reports 0 study locations.
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.
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