Roche trials database

Trial information

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

Status:

Active, not recruiting

Protocol number:

BP27801

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific 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

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. Target sample size is 19.

Study phase:

I

Study type:

Interventional; Other; Randomized; Crossover; Safety study

Conditions:

• Autistic Disorder

Intervention type:

Drug

Intervention name:

RO5028442

Primary outcome:

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

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

Gender:

Males

Age limits:

Min: 18 years Max: 45 years

Accepts healthy volunteers:

No

Anticipated start date:

December, 2011

Trial registration date:

22.08.2011

Date last updated:

06.05.2013

This trial was conducted at the following locations:

U.S.A.

• LOS AGELES, CA
• NEW HAVEN, CT
• BRONX, NY

Link to trial result