A Study With RO4917523 in Patients With Fragile X Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Fragile X Syndrome

In brief

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.

Key facts

Study ID

NCT01015430

Run by

Hoffmann-La Roche

People needed

40

Starts

2009-11-01

Expected to finish

2011-01-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients, 18 to 50 years of age
• Fragile X Syndrome
• IQ less than 75
• Reliable caregiver

You may not qualify if…

• 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

Where it is running

• Study site — Sacramento, California, United States
• Study site — Decatur, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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