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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01474278
First received: November 15, 2011
Last updated: November 3, 2014
Last verified: November 2014

November 15, 2011
November 3, 2014
December 2011
March 2013   (final data collection date for primary outcome measure)
  • Efficacy: Behavior assessments [ Time Frame: up to 24 hours post-dose ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 24 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01474278 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
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

This multi-center, randomized, double-blind study will evaluate exploratory biom arkers and the safety and tolerability of a single dose of RO5028442 in adult ma le 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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Autistic Disorder
  • Drug: Placebo
    Single dose
  • Drug: RO5028442
    Single dose
  • Experimental: 1
    Intervention: Drug: RO5028442
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01474278
BP27801
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP