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

Autistic Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474278
• Other study ID #: BP27801
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2011
• Last updated: November 1, 2016
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Drug:
• Placebo
Single dose
• RO5028442
Single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Behavior assessments		up to 24 hours post-dose	No
Primary	Safety: Incidence of adverse events		up to 24 hours post-dose	No