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NCT02484703 · ClinicalTrials.gov registry record · Phase 2
A Study of RO5186582 in Down Syndrome Among Children 6 to 11 Years of Age
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT02484703 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 45 participants.
The verdict
NCT02484703, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
This study will evaluate the safety, tolerability, efficacy, and pharmacokinetic and pharmacodynamic activity of 3 different dosages of RO5186582 compared with placebo. A total of approximately 46 participants will be enrolled, in order to have at least 32 evaluable, and will be randomly assigned to 1 of 4 treatments in a 1:1:1:1 ratio, with 9 children per treatment arm. The target ratio between 6-8 years and 9-11 years age groups is approximately 1:1 in each treatment arm, with a minimum of 3 children per age group in each treatment arm.
Interventions
- DRUG Placebo
- DRUG RO5186582
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2015-10-28 |
| Est. Completion | 2016-08-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02484703
The ClinicalTrials.gov registry entry for NCT02484703 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 45 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.
NCT02484703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02484703 about?
NCT02484703 is a clinical study titled "A Study of RO5186582 in Down Syndrome Among Children 6 to 11 Years of Age". This study will evaluate the safety, tolerability, efficacy, and pharmacokinetic and pharmacodynamic activity of 3 different dosages of RO5186582 compared with placebo. A total of approximately 46 participants will be enrolled, in order to have at least 32 evaluable, and will be randomly assigned to...
What is the current status of trial NCT02484703?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2015-10-28. Estimated completion is 2016-08-03.
What interventions are being tested in trial NCT02484703?
The interventions under investigation include: Placebo (DRUG), RO5186582 (DRUG).
Who is sponsoring clinical trial NCT02484703?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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