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

NCT ID: NCT02555150

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-01-31

Brief 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.

Detailed Description

Young adult drivers with Attention Deficit Hyperactivity Disorder (ADHD) will be compared on a driving simulator after taking PRC-063 or LDX in a repeated-measure, randomized, doubleblind, crossover study design. Each subject will be randomized to receive up to a 21-day course of PRC-063 followed by up to a 21 day course of LDX or vice versa. There will be no washout between treatments. On days 1 through 7, subjects will receive the lowest dose (45 mg of PRC-063 or 30 mg of LDX) of study medication. On days 8 through 14, subjects will receive the middle dose (70 mg of PRC-063 or 50 mg of LDX). On days 15 through 21, subjects will receive the highest dose (100 mg of PRC-063 or 70 mg of LDX). During Days 1 through 21, if a subject is responding satisfactorily to medication, he or she may remain on that daily dose. Driving laboratory testing will be conducted between Day 17 and Day 21. Following the laboratory testing, the subject will begin a second titration of the alternate treatment, starting on Day 22 through Day 28 at the lowest dose (45 mg of PRC-063 or 30 mg of LDX) of study medication, Day 29 through Day 35 on the middle dose (70 mg of PRC-063 or 50 mg of LDX) and Day 36 through Day 42 on the highest dose (100 mg of PRC-063 or 70 mg of LDX). During Days 22 through 42, if a subject is responding satisfactorily to medication, he or she may remain on that daily dose. Following titration with the second treatment, subjects will attend a second driving laboratory testing, conducted between Day 38 to Day 42. Subjects will subsequently attend a safety and study termination visit.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PRC-063

Titration during which subjects will be titrated from a starting dose of 45 mg/day (dosed once daily) of PRC-063 oral capsules up to his/her final dose (45, 70 or 100 mg/day of PRC-063). This phase will be 10 to 21 days long.

Group Type: ACTIVE_COMPARATOR

PRC-063

Intervention Type: DRUG

Oral extended-release capsule

Placebo

Intervention Type: DRUG

Oral placebo capsule

lisdexamfetamine dimesylate

Titration during which subjects will be titrated from a starting dose of 30 mg/day of lisdexamfetamine up to his/her final dose (30, 50 or 70 mg/day of LDX). This phase will be 10 to 21 days long.

Group Type: ACTIVE_COMPARATOR

lisdexamfetamine dimesylate

Intervention Type: DRUG

Oral capsule

Placebo

Intervention Type: DRUG

Oral placebo capsule

Placebo

Subjects will be dosed once daily with a placebo oral capsule for 10 to 21 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo capsule

Interventions

PRC-063

Oral extended-release capsule

Intervention Type: DRUG

lisdexamfetamine dimesylate

Oral capsule

Intervention Type: DRUG

Placebo

Oral placebo capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Male or non-pregnant, non-nursing female at least 18 years of age and less than or equal to 25 years of age with a valid driver's license and at least six months of driving experience with driving activity at least twice per week.

ADHD diagnosis, inattentive, hyperactive/impulsive or combined, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) based on clinician assessment using the Structured Clinical Interview for DSM Disorders (SCID).

Dissatisfaction with his or her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects naïve to pharmacological therapy for ADHD is permitted.

Exclusion Criteria

Known to be non-responsive to methylphenidate or lisdexamfetamine treatment. Nonresponse is defined as methylphenidate or lisdexamfetamine use at various doses for a phase of at least four weeks at each dose with little or no clinical benefit in the last 10 years.

Having a history of motion, sea or big screen (e.g. IMAX) sickness, in order to avoid possible Simulation Adaptation Syndrome.

Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: collaborator

Rhodes Pharmaceuticals, L.P.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Reiz

Role: STUDY_DIRECTOR

Purdue Pharma LP

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

063-013

Identifier Type: -

Identifier Source: org_study_id