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: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Autistic Disorder
Drug: RO5028442
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Enrollment: 19
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO5028442
Single dose
Placebo Comparator: 2 Drug: Placebo
Single dose

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01474278     History of Changes
Other Study ID Numbers: BP27801
Study First Received: November 15, 2011
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014