Completed

A Multi-Center, Randomized, Double-Blind, 12-Week, Parallel Group, Placebo-Controlled Proof of Concept Study to Investigate the Efficacy and Safety of RG7314 in Individuals With Autism Spectrum Disorders (ASD)

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What is being tested

Placebo

+ RG7314

Drug
Who is being recruted

Mental Disorders+1

+ Child Development Disorders, Pervasive

+ Neurodevelopmental Disorders

From 18 to 45 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: September 2013
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: February 3, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2013

Actual date on which the first participant was enrolled.

This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult participants with ASD. In Stage I of the study, participants will be randomized in 2:1 to receive daily oral doses of 1.5 milligrams (mg) RG7314 or placebo for 12 weeks. After an independent safety review, the study may proceed to Stage II. In Stage II of the study, additional participants will be randomized in 2:1 to receive daily oral doses of 4 mg RG7314 or placebo for 12 weeks. After an independent safety review, Stage III will be started wherein additional participants will be randomized in 2:1 to receive daily oral doses of 10 mg RG7314 or placebo for 12 weeks. During Stage III, safety will be reviewed by independent safety review twice and if no safety signal is observed, then additional participants will be randomized in 1:1:1 either to receive 1.5 milligrams per day (mg/day) or 10 mg/day RG7314 orally or placebo for 12 weeks in Stage IV.

NCT01793441
Principal SponsorHoffmann-La Roche
Last updated: February 3, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

223 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersChild Development Disorders, PervasiveNeurodevelopmental DisordersAutism Spectrum Disorder

Criteria

7 inclusion criteria required to participate
A body mass index (BMI) between 18 to 40 kilograms per square meter (kg/m^2) inclusive
CGI-S >= 4 (moderately ill)
Language, hearing and vision compatible with the study measurements as judged by the investigator
Lives with (or has substantial periods of contact with) a caregiver who is willing and able to attend visits when required, oversee the participant's compliance with protocol-specified procedures and study medication dosing, and report on the participant's status via completion of study assessments. Any period of absence must be covered by another caregiver. Non-cohabitating caregiver(s) must spend sufficient time with the participant so that, in the opinion of the investigator, the caregiver(s) can reliably assess participant's mental status, activities and behavior
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7 exclusion criteria prevent from participating
A significant risk for suicidal behavior, in the opinion of the investigator
Alcohol and/or substance abuse/dependence during the last 12 months
Initiation of a new major change in psychological intervention within 4 weeks prior to randomization. Minor changes in ongoing treatment are not considered significant
Participation in an investigational drug or device study within 60 days prior to randomization
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Participants will receive placebo matching to RG7314 in each stage (Stage I, II, III and IV) for 12 weeks.

Group II

Experimental
Participants will receive RG7314 orally at a dose of 1.5 mg/day in Stage I, 4 mg/day in Stage II, 10 mg/day in Stage III and 1.5 mg/day or 10 mg/day in Stage IV for 12 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 56 locations

Southwest Autism Research & Resource Center

Phoenix, United StatesOpen Southwest Autism Research & Resource Center in Google Maps

Phoenix, United States

University of California Davis

Sacramento, United States

Sacramento, United States
Completed56 Study Centers