Attention Deficit Hyperactivity DisorderPhase 3NCT02555150
A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD
A Phase 3 study testing PRC-063 and lisdexamfetamine dimesylate in people with Attention Deficit Hyperactivity Disorder, run by Rhodes Pharmaceuticals, L.P. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- PRC-063 and lisdexamfetamine dimesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jan 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: 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.
Read the 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
- Being tested
- PRC-063, lisdexamfetamine dimesylate, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRC-063Drug
Oral extended-release capsule
lisdexamfetamine dimesylateDrug
Oral capsule
PlaceboDrug
Oral placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PRC-063; Drug: 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. Receives: Drug: lisdexamfetamine dimesylate; Drug: Placebo |
| Placebo | Placebo comparator | Subjects will be dosed once daily with a placebo oral capsule for 10 to 21 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 21 days (Visit 9)
Secondary outcomes (2)
Number of Participants with Adverse Events
Summary of adverse events reported during the study
Measured: 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
Measured: At one week and nine weeks of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Responsible party
- Sponsor
- Investigators
- Joseph Reiz, Study director, Purdue Pharma LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555150
- Sponsor's protocol ID
- 063-013
- Status last verified
- Jan 2017
- First submitted
- 28 Aug 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 3, Double-Blind, Crossover Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD
- ClinicalTrials.gov ID
- NCT02555150
- Acronym / sponsor ID
- 063-013
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Study start
- Sep 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRC-063 | Active comparator | Drug: PRC-063, Drug: PlaceboTitration 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. |
| lisdexamfetamine dimesylate | Active comparator | Drug: lisdexamfetamine dimesylate, Drug: PlaceboTitration 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. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be dosed once daily with a placebo oral capsule for 10 to 21 days. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRC-063Oral extended-release capsule | Drug | PRC-063 |
| lisdexamfetamine dimesylateOral capsule | Drug | lisdexamfetamine dimesylate |
| PlaceboOral placebo capsule | Drug | PRC-063, Placebo, lisdexamfetamine dimesylate |
Primary outcome
Tactical Driving Quotient (TDQ)
Time frame: At 21 days (Visit 9)
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.
2 secondary outcomes
Number of Participants with Adverse Events
Time frame: Participants will be followed for the duration of the study, an expected average of 10 weeks
Columbia Suicide Severity Rating Scale (CSSRS)
Time frame: At one week and nine weeks of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Reiz study director
Purdue Pharma LP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRC-063 and lisdexamfetamine dimesylate in people with Attention Deficit Hyperactivity Disorder, run by Rhodes Pharmaceuticals, L.P. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactical Driving Quotient (TDQ) (time frame: At 21 days (Visit 9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.