NCT02555150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

August 28, 2015

Last Update Submit

January 17, 2017

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of Participants with Adverse Events

    Participants will be followed for the duration of the study, an expected average of 10 weeks

  • Columbia Suicide Severity Rating Scale (CSSRS)

    At one week and nine weeks of the study

Study Arms (3)

PRC-063

ACTIVE COMPARATOR

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: PRC-063Drug: Placebo

lisdexamfetamine dimesylate

ACTIVE COMPARATOR

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: lisdexamfetamine dimesylateDrug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PRC-063DRUG

Oral extended-release capsule

PRC-063
lisdexamfetamine dimesylateDRUG

Oral capsule

lisdexamfetamine dimesylate
PlaceboDRUG

Oral placebo capsule

PRC-063Placebolisdexamfetamine dimesylate

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DextroamphetamineAmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Joseph Reiz

    Purdue Pharma LP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 21, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)