Trial intelligence / Profile preview

Examining Tolerance to CNS Stimulants in ADHD

NCT02039908Phase 4

Key facts

Status
Completed
Start
Apr 2013
Primary completion
May 2018
Countries
1
Sponsor
Florida International University
Modality
Small Molecules
Conditions
attention deficit hyperactivity disorder (ADHD)
01

Overview

Phase 4, randomised, double-blind trial of methylphenidate in attention deficit hyperactivity disorder (ADHD), sponsored by Florida International University. Primary endpoint: Number of Dose Changes Required Per Protocol at 10 months. Started Apr 2013; status: completed.

02

Design

Study design
RandomizedDouble-blind
03

Who it enrols

Children with ADHD and IQ > 80, excluding those with other psychotropic meds, autism, or methylphenidate intolerance.

04

Endpoints

Primary

  • Number of Dose Changes Required Per Protocol

Secondary

  • Time to First Dose Increase

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