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

Phase 1
Completed
Conditions
Autistic Disorder
Interventions
Drug: RO5028442
Drug: 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
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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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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
1RO5028442-
2Placebo-
Primary Outcome Measures
NameTimeMethod
Efficacy: Behavior assessmentsup to 24 hours post-dose
Safety: Incidence of adverse eventsup to 24 hours post-dose
Secondary Outcome Measures
NameTimeMethod
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