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

NCT01474278 | Completed Phase 1

• 1 other identifier: BP27801
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

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.

Conditions

Autistic Disorder

Outcome Measures

Primary Outcomes (2)

• Efficacy: Behavior assessments

  up to 24 hours post-dose

• Safety: Incidence of adverse events

  up to 24 hours post-dose

Study Arms (2)

1

EXPERIMENTAL

Drug: RO5028442

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Single dose

2

RO5028442 DRUG

Single dose

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Los Ageles, California, 90095, United States

Location

Unknown Facility

New Haven, Connecticut, 06510, United States

Location

Unknown Facility

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Umbricht D, Del Valle Rubido M, Hollander E, McCracken JT, Shic F, Scahill L, Noeldeke J, Boak L, Khwaja O, Squassante L, Grundschober C, Kletzl H, Fontoura P. A Single Dose, Randomized, Controlled Proof-Of-Mechanism Study of a Novel Vasopressin 1a Receptor Antagonist (RG7713) in High-Functioning Adults with Autism Spectrum Disorder. Neuropsychopharmacology. 2017 Aug;42(9):1914-1923. doi: 10.1038/npp.2016.232. Epub 2016 Oct 6.

  PMID: 27711048 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

(6-chloro-1-(2-(dimethylamino)ethyl)indol-3-yl)-spiro(1H-isobenzofuran-3,4'-piperidine)-1'-yl-methanone

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 18, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (3)