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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01474278
• Collaborator: (none)
• Enrollment: 19
• Locations: 3
• Arms: 2
• Duration (Months): 15
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.4

Study Details

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
• 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: Dec 1, 2011
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 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 [up to 24 hours post-dose]

2. Safety: Incidence of adverse events [up to 24 hours post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Los Ageles	California	United States	90095
2		New Haven	Connecticut	United States	06510
3		Bronx	New York	United States	10467

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01474278
• Other Study ID Numbers: BP27801
• First Posted: Nov 18, 2011
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Autistic Disorder

Study Results

No Results Posted as of Nov 2, 2016