A Study of RO5028442 in Adult Male High-Functioning Autistic Patients

Completed · Phase 1 · Has a placebo group

Conditions studied: Autistic Disorder

In brief

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.

Key facts

Study ID

NCT01474278

Run by

Hoffmann-La Roche

People needed

19

Starts

2011-12-01

Expected to finish

2013-03-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Los Ageles, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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