A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
Phase 1
Completed
- Conditions
- Autistic Disorder
- Interventions
- Drug: RO5028442Drug: Placebo
- Registration Number
- NCT01474278
- Lead Sponsor
- Hoffmann-La Roche
- 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 19
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 </= 13
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 RO5028442 - 2 Placebo -
- Primary Outcome Measures
Name Time Method Efficacy: Behavior assessments up to 24 hours post-dose Safety: Incidence of adverse events up to 24 hours post-dose
- Secondary Outcome Measures
Name Time Method