A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 8/3/2016 |
| Start Date: | December 2011 |
| End Date: | March 2013 |
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over, Exploratory Biomarker and Safety and Tolerability Study of a Single Dose of RO5028442 in Adult Male High-functioning Autistic Patients
This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and
the safety and tolerability of a single dose of RO5028442 in adult male high-functioning
autistic patients. In a cross-over design, patients will be randomized to receive either a
single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated
time on study is up to approximately 9 weeks.
the safety and tolerability of a single dose of RO5028442 in adult male high-functioning
autistic patients. In a cross-over design, patients will be randomized to receive either a
single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated
time on study is up to approximately 9 weeks.
Inclusion Criteria:
- Patients with a diagnosis of Autistic Disorder as defined by DSM-IV, confirmed by the
team and supported with the Autistic Diagnostic Observation Schedule (ADOS)
- Male adults, 18 to 45 years of age
- IQ > 70 (Wechsler Adult Intelligence Scale-Full scale)
- Body mass index (BMI) 18 to 35 kg/m2 inclusive
- Aberrant Behavior Checklist (ABC) - Irritability subscale score
Exclusion Criteria:
- Positive urine test for drugs of abuse
- Alcohol and/or substance abuse/dependence during the last 12 months
- Positive for hepatitis B, hepatitis C or HIV infection
- Clinically relevant cardiovascular, renal, hepatic or hematologic disease or disorder
- Active inflammatory pulmonary disease
- History of epilepsy/seizure disorder (except for simple febrile seizures)
- Initiation of new or major change in psychosocial intervention within 4 weeks prior
to randomization
- Treatment with any investigational agent within 90 days prior to screening
- History of hypersensitivity or allergic reactions
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