A Study With RO4917523 in Patients With Fragile X Syndrome

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Adult patients, 18 to 50 years of age

• Fragile X Syndrome

• IQ less than 75

• Reliable caregiver

Exclusion Criteria:

• Current psychosis or presumption of psychosis

• History of suicidal behavior or considered a high suicidal risk

• Severe self-injurious behavior

• Any unstable medical condition other than Fragile X Syndrome (e.g. hypertension, diabetes)

• Current seizure disorder