Trial intelligence / Profile preview

Metformin for Antipsychotic-Induced Overweight in ASD

NCT01825798Phase 3

Key facts

Status: Completed
Start: Apr 2013
Primary completion: Jun 2015
Countries: 2
Sponsor: Holland Bloorview Kids Rehabilitation Hospital
Modality: Small Molecules

Drugs: liquid metformin (Aspargo Labs)
Conditions: Overweight

Overview

Phase 3, randomised, double-blind trial of liquid metformin (Aspargo Labs) in Overweight (2 arms), sponsored by Holland Bloorview Kids Rehabilitation Hospital. Primary endpoint: Change in Body Mass Index Z-score at 16 weeks. Started Apr 2013; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Metformin
Metformin oral solution (Riomet), titrated to 500-850 mg twice daily based on age and tolerance.
Placebo
Placebo oral solution matching Metformin.

Who it enrols

Children and adolescents (6-17 years) with ASD who have been on a stable dose of atypical antipsychotic medication for at least 1 month and have experienced significant weight gain (>7% BMI increase or >85th percentile with >5% increase/year).

Endpoints

Primary

Change in Body Mass Index Z-score16 weeks

Secondary

Absolute Change in Weight16 weeks
Relative Change in Weight16 weeks
Absolute BMI16 weeks
Changes in Abdominal Circumference16 weeks
Changes in Hip Circumference16 weeks
Changes in Total Cholesterol16 weeks
Changes in LDL Cholesterol16 weeks
Changes in HDL Cholesterol16 weeks

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