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RO5028442

Phase 1

Autistic Disorder | Small molecule | Psychiatry |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

RO5028442 · 1 trial · 1 indication

Phase 1 1
NCT01474278A Study of RO5028442 in Adult Male High-Functioning Autistic PatientsAutistic Disorder
COMPLETED19 Analytics
PHASE1COMPLETED
A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
Autistic DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy: Behavior assessments
up to 24 hours post-dose
Safety: Incidence of adverse events
up to 24 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGSingle dose
RO5028442DRUGSingle dose
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersNo
Study Sites3

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 (B...

Countries:United States
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Frequently asked questions about RO5028442

What is RO5028442 used for?

RO5028442 is an investigational small molecule being studied for the treatment of Autistic Disorder. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being developed by Roche Holding AG.

What does RO5028442 target?

The molecular target of RO5028442 has not been disclosed in available information. The drug is being investigated for its potential effects in patients with Autistic Disorder, but its specific mechanism of action is not publicly detailed.

Who makes RO5028442?

RO5028442 is being developed by Roche Holding AG, a multinational healthcare company. The company's stock is traded under the ticker RHHBY. The drug is currently in Phase 1 clinical development for Autistic Disorder.

What phase is RO5028442 in?

RO5028442 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of Autistic Disorder.

What clinical trials is RO5028442 in?

RO5028442 has one completed clinical trial, NCT01474278, titled "A Study of RO5028442 in Adult Male High-Functioning Autistic Patients." This Phase 1 study enrolled 19 participants in the United States and was a randomized, double-blind, placebo-controlled trial.

Is RO5028442 the same as other drugs?

No alternative names for RO5028442 have been disclosed in available information. The drug is identified solely by its code name RO5028442 and is being developed by Roche Holding AG for Autistic Disorder.