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drugset / Trial / NCT03172481

PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD

NCT03172481 ↗

Phase 3 Completed 156 enrolled Purdue Pharma, Canada
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric subjects between 6 to 12 years of age.

Timeline

Start
2017-05-01
Primary completion
2017-08-19
Completion
2017-12-19

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 25 mg Oral
Subject Methylphenidate Small molecule 35 mg Oral
Subject Methylphenidate Small molecule 45 mg Oral
Subject Methylphenidate Small molecule 55 mg Oral
Subject Methylphenidate Small molecule 70 mg Oral
Subject Methylphenidate Small molecule 85 mg Oral

Indications

attention deficit-hyperactivity disorder