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NCT01793441 · ClinicalTrials.gov registry record · Phase 2
A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 223
- Enrollment target
NCT01793441 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 223 participants.
The verdict
NCT01793441, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 223 participants
- Enrollment target
Study Summary
This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult participants with ASD. In Stage I of the study, participants will be randomized in 2:1 to receive daily oral doses of 1.5 milligrams (mg) RG7314 or placebo for 12 weeks. After an independent safety review, the study may proceed to Stage II. In Stage II of the study, additional participants will be randomized in 2:1 to receive daily oral doses of 4 mg RG7314 or placebo for 12 weeks. After an independent safety review, Stage III will be started wherein additional participants will be randomized in 2:1 to receive daily oral doses of 10 mg RG7314 or placebo for 12 weeks. During Stage III, safety will be reviewed by independent safety review twice and if no safety signal is observed, then additional participants will be randomized in 1:1:1 either to receive 1.5 milligrams per day (mg/day) or 10 mg/day RG7314 orally or placebo for 12 weeks in Stage IV.
Interventions
- DRUG Placebo
- DRUG RG7314
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01793441
The ClinicalTrials.gov registry entry for NCT01793441 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 223 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.
NCT01793441 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01793441 about?
NCT01793441 is a clinical study titled "A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)". This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult participants with ASD. In Stage I of the study, participants will be randomized in 2:1 to receive daily oral doses of 1.5 milligrams (mg...
What is the current status of trial NCT01793441?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 223 participants. The study started on 2013-09. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01793441?
The interventions under investigation include: Placebo (DRUG), RG7314 (DRUG).
Who is sponsoring clinical trial NCT01793441?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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