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A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD

NCT02555150 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-01-19

No results posted yet for this study

Summary

The purpose of this randomized, double-blind, crossover study is to compare two long-acting stimulant formulations-once-daily PRC-063 and once-daily lisdexamfetamine (LDX)-through a 15-hour period on driving performance, as measured with a driving simulator, in adult patients with ADHD.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

PRC-063

Oral extended-release capsule

DRUG

lisdexamfetamine dimesylate

Oral capsule

DRUG

Placebo

Oral placebo capsule

Sponsors & Collaborators

  • Purdue Pharma LP

    collaborator INDUSTRY

  • Rhodes Pharmaceuticals, L.P.

    lead INDUSTRY

Principal Investigators

  • Joseph Reiz · Purdue Pharma LP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02555150 on ClinicalTrials.gov