Date: 2012-05-01
Type of information: Initiation of the trial
phase: 2
Announcement: initiation
Company: Roche (Switzerland)
Product: RG7090 - RO4917523
Action
mechanism: RG7090 - RO4917523 is a metabotropic glutamate receptor 5 (mgluR5) inhibitor.
Disease: fragile X syndrome
Therapeutic area: Genetic diseases - Rare diseases
Country: USA, Argentina, Chile, Mexico
Trial
details: This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks. An estimated number of 180 patients will be enrolled in the study to be completed in November 2013.
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