A Study With RO4917523 in Patients With Fragile X Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 8/3/2016 |
| Start Date: | November 2009 |
| End Date: | January 2011 |
A Randomized, Double-blind, Placebo-controlled, Pharmacokinetic, Safety and Tolerability, and Exploratory Efficacy and Pharmacodynamic Effects Study of RO4917523 in Adult 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 6 weeks. The target sample size is <100 patients.
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.
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
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