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PRC-063 in an ADULT Workplace Environment

NCT02225639 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-07-09

No results posted yet for this study

Summary

The primary objective of this study is to assess the time of onset and time course of efficacy over 16 hours of PRC-063 compared to placebo in adults diagnosed with ADHD in a simulated adult workplace environment (AWE) setting, as measured by the PERMP (an individually-adjusted math test) at pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose.

Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

DRUG

PRC-063 25 mg

Oral 25 mg capsule - active

DRUG

Placebo

Oral placebo capsule

DRUG

PRC-063 35 mg

Oral 35 mg capsule - active

DRUG

PRC-063 45 mg

Oral 45 mg capsule - active

DRUG

PRC-063 55 mg

Oral 55 mg capsule - active

DRUG

PRC-063 70 mg

Oral 70 mg capsule - active

DRUG

PRC-063 85 mg

Oral 85 mg capsule - active

DRUG

PRC-063 100 mg

Oral 100 mg capsule - active

Sponsors & Collaborators

  • Purdue Pharma LP

    collaborator INDUSTRY

  • Rhodes Pharmaceuticals, L.P.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-04-30
Completion
2015-05-31

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 NCT02225639 on ClinicalTrials.gov