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

A Randomized, Phase 3, Double-Blind, Crossover Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Placebo; Drug: PRC-063; Drug: lisdexamfetamine dimesylate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Placebo; Oral placebo capsule; Drug: PRC-063; Oral extended-release capsule
Active Comparator: 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.	Drug: Placebo; Oral placebo capsule; Drug: lisdexamfetamine dimesylate; Oral capsule
Placebo Comparator: Placebo; Subjects will be dosed once daily with a placebo oral capsule for 10 to 21 days.	Drug: Placebo; Oral placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tactical Driving Quotient (TDQ)	The primary outcome measure will be the Tactical Driving Quotient (TDQ) between treatments. The TDQ is an accumulative effect size across multiple driving variables collected during the driving simulation, including: summed standard deviations of steering, driving off the road, veering across the midline, inappropriate braking while on the open road, missed stop signs, exceeding speed limit, standard deviation of speed, time at stop sign deciding when to turn left and time to complete left turns. A higher TDQ score reflects better driving skill. A TDQ of 100 represents average driving and the standard deviation of normal distribution is 15. The normal range of driving (+/- 1.0 SD) is 85 to 115. A TDQ of less than 100 represents worse than average driving (e.g., a TDQ of 115 represents driving performance 1 SD better than average) and a TDQ of greater than 100 represents better than average driving.	At 21 days (Visit 9)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events	Summary of adverse events reported during the study	Participants will be followed for the duration of the study, an expected average of 10 weeks
Columbia Suicide Severity Rating Scale (CSSRS)	A Columbia Suicide Severity Rating Scale (CSSRS) assessment will be administered by the investigator to all study participants	At one week and nine weeks of the study

Collaborators and Investigators

• Sponsor: Rhodes Pharmaceuticals, L.P.
• Collaborators: Purdue Pharma LP
• Investigators: Study Director: Joseph Reiz, Purdue Pharma LP

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: August 28, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimate): September 21, 2015

Study Record Updates

• Last Update Posted (Estimate): January 19, 2017
• Last Update Submitted That Met QC Criteria: January 17, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: 063-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO