Status:
COMPLETED
A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Autistic Disorder
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
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. I...
Eligibility Criteria
Inclusion
- 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 \</= 13
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01474278
Start Date
December 1 2011
End Date
March 1 2013
Last Update
November 2 2016
Active Locations (3)
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1
Los Ageles, California, United States, 90095
2
New Haven, Connecticut, United States, 06510
3
The Bronx, New York, United States, 10467