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.
Brief Title
A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
Categories
Completion Date
Completion Date Type
Actual
Conditions
Autistic Disorder
Eligibility Criteria
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
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
* 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 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
Inclusion Criteria
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
* 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
Gender
Male
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
45 Years
Minimum Age
18 Years
NCT Id
NCT01474278
Org Class
Industry
Org Full Name
Hoffmann-La Roche
Org Study Id
BP27801
Overall Status
Completed
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Measure
Efficacy: Behavior assessments
Outcome Time Frame
up to 24 hours post-dose
Outcome Measure
Safety: Incidence of adverse events
Outcome Time Frame
up to 24 hours post-dose
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
45
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Eric Hollander
Investigator Email
eholland@montefiore.org
Investigator Phone
718-920-4287