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NCT Number: NCT01474278

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

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.

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Key information

Conditions

Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Los Ageles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Single dose

RO5028442

Drug

Single dose

Primary outcomes

  1. Efficacy: Behavior assessments

    Time frame: up to 24 hours post-dose

  2. Safety: Incidence of adverse events

    Time frame: up to 24 hours post-dose

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 18, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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