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NCT01015430 · ClinicalTrials.gov registry record · Phase 2
A Study With RO4917523 in Patients With Fragile X Syndrome
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01015430: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01015430 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01015430, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This randomized, double-blind multiple ascending dose study will evaluate the safety and tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome. The patients will be randomized to receive either active drug or placebo. The anticipated time on study treatment is 6 weeks. The target sample size is \<100 patients.
Interventions
- DRUG RO4917523
- DRUG Placebo (for RO4917523 ascending doses)
- DRUG Placebo (for RO4917523 fixed dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT01015430 record still lists
NCT01015430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which RO4917523 is the first listed.
NCT01015430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01015430 about?
NCT01015430 is a clinical study titled "A Study With RO4917523 in Patients With Fragile X Syndrome". This randomized, double-blind multiple ascending dose study will evaluate the safety and tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome. The patients will be randomized to receive either active drug or placebo. The anticipated time on study treatment is ...
What is the current status of trial NCT01015430?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2009-11. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01015430?
The interventions under investigation include: RO4917523 (DRUG), Placebo (for RO4917523 ascending doses) (DRUG), Placebo (for RO4917523 fixed dose) (DRUG).
Who is sponsoring clinical trial NCT01015430?
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 NCT01015430's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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