A Phase 2 interventional study of Placebo (for RO4917523 ascending doses) and Placebo (for RO4917523 fixed dose) in Fragile X Syndrome, sponsored by Hoffmann-La Roche. Completed at 5 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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.
110 studies on the registry are indexed under Fragile X Syndrome; 23 are open to participants now.
This study's enrollment of 40 is below the median of 58 across 88 interventional studies indexed under Fragile X Syndrome.
Browse Fragile X Syndrome studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo (for RO4917523 ascending doses) · Drug: Placebo (for RO4917523 fixed dose)
Drug: Placebo (for RO4917523 ascending doses) · Drug: Placebo (for RO4917523 fixed dose)
Drug: RO4917523
Drug: RO4917523
Placebo daily po
Placebo daily po
RO4917523 ascending doses daily po
RO4917523 fixed dose daily po
Safety, Tolerability and Pharmacokinetics: AEs, laboratory parameters
Time frame: AEs throughout study; laboratory assessments: days 1, 8, 15, 29, 43
Efficacy: Behavior and cognition assessments
Time frame: Every 2 weeks throughout study
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche