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NCT01474278 · ClinicalTrials.gov registry record · Phase 1
A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01474278: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01474278 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01474278, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and the safety and tolerability of a single dose of RO5028442 in adult male high-functioning autistic patients. In a cross-over design, patients will be randomized to receive either a single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated time on study is up to approximately 9 weeks.
Interventions
- DRUG Placebo
- DRUG RO5028442
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01474278 record still lists
NCT01474278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01474278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01474278 about?
NCT01474278 is a clinical study titled "A Study of RO5028442 in Adult Male High-Functioning Autistic Patients". This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and the safety and tolerability of a single dose of RO5028442 in adult male high-functioning autistic patients. In a cross-over design, patients will be randomized to receive either a single dose of RO5028442 or m...
What is the current status of trial NCT01474278?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-12. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01474278?
The interventions under investigation include: Placebo (DRUG), RO5028442 (DRUG).
Who is sponsoring clinical trial NCT01474278?
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 NCT01474278's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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