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CompletedNCT01474278Updated Nov 2, 2016

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

A Phase 1 interventional study of Placebo and RO5028442 in Autistic Disorder, sponsored by Hoffmann-La Roche. Completed at 3 sites in United States. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
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Study 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.

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Conditions studied

  • Autistic Disorder

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In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 19 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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
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Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    1

    Drug: RO5028442

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • DrugPlacebo

    Single dose

  • DrugRO5028442

    Single dose

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What researchers measure

Primary outcomes

  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

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Study locations

3 sites
  • Los Ageles, California 90095, United States
  • New Haven, Connecticut 06510, United States
  • Bronx, New York 10467, United States
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References and documents

Publications

  • 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. Erratum In: Neuropsychopharmacology. 2017 Aug;42(9):1924. doi: 10.1038/npp.2017.92. PubMed 27711048 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01474278
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Nov 18, 2011
Start date
Dec 2011
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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