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

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ClinicalTrials.gov Identifier: NCT01474278
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: Placebo Drug: RO5028442 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : December 2011
Primary Completion Date : March 2013
Study Completion Date : March 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: RO5028442
Single dose
Placebo Comparator: 2 Drug: Placebo
Single dose


Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474278


Locations
United States, California
Los Ageles, California, United States, 90095
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, New York
Bronx, New York, United States, 10467
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01474278     History of Changes
Other Study ID Numbers: BP27801
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders