Attention Deficit Hyperactivity Disorder (ADHD)Phase 3NCT02225639
PRC-063 in an ADULT Workplace Environment
A Phase 3 study testing PRC-063 25 mg, PRC-063 35 mg and PRC-063 45 mg in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Rhodes Pharmaceuticals, L.P. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- PRC-063 25 mg, PRC-063 35 mg and PRC-063 45 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to May 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be male or non-pregnant female at least 18 years of age and less than or equal to 60 years of age.
- Must have an ADHD diagnosis, in attentive, hyperactive/impulsive or combined, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) based on clinician assessment using multiple informants and a structured interview.
- Clinician-completed ADHD-5-RS total score must be equal to or greater than 24, as assessed at Visit 2a.
- Must be unsatisfied 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.
- Female subjects must be one of the following: a. surgically sterile prior to screening; b. if of childbearing potential, abstinent or willing to use a reliable method of contraception, such as oral contraceptive, two barrier methods, a barrier method plus a spermicidal agent.
- Female subjects of Child-Bearing Potential (FOCP) must be a negative serum β-hCG pregnancy test at screening.
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- Must have a minimum level of intellectual functioning, as determined by an Intelligence Quotient (IQ) score of 80 or above based on the KBIT-2.
- Mentally and physically competent to sign an informed assent document, in the case of the subject, and an informed consent document, in the case of the parent/guardian, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Able and willing to comply with the study procedures for the entire length of the study, including a successful swallow test of an empty 100 mg capsule.
Who cannot join
- Having an allergy to methylphenidate or amphetamines or a history of serious adverse reactions to methylphenidate.
- Known to be non-responsive to methylphenidate treatment. Non-response is defined as methylphenidate 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.
- Being diagnosed with or having a history of strokes, epilepsy, migraine headaches (greater than 1 instance every two months), glaucoma, thyrotoxicosis, tachyarrhythmias or severe angina pectoris or have serious or unstable medical illness. Subjects with controlled or stable asthma or diabetes will be permitted.
- Elevated blood pressure, defined as any values above 89 diastolic or 139 systolic, as assessed at Visit 1.
- Clinically significant ECG abnormalities, as assessed at Visit 1.
- Clinically significant laboratory abnormalities, as assessed at Visit 1.
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- Currently receiving guanethidine, pressor agents, MAO inhibitors, coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), phenylbutazone, tricyclic antidepressants (e.g., imipramine, desipramine), selective serotonin reuptake inhibitors (SSRIs) or herbal remedies (unless on a stable dose for 4 weeks).
- Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary heart disease, transient ischemic attack or stroke or other serious cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- Subjects who are currently considered a suicide risk by the investigator.
- Having a primary diagnosis of schizophrenia, schizoaffective disorder, primary affective disorder, schizotypal personality, major depression, bipolar disorder, generalized anxiety, borderline personality disorder, antisocial personality or another unstable psychiatric condition requiring treatment, as assessed by the structured interview conducted at Visit 1.
- Having a history or suspected physiological dependence within the past 5 years (excluding nicotine) on narcotic analgesics or other psychoactive drugs (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines).
- Excessive consumption of alcohol (consumes alcohol in quantities greater than 15 drinks per week; 1 drink is defined as 360 mL/12 oz. of beer, 120 mL/4 oz. of wine, or 30 mL/1 oz. of hard liquor), or history (within previous 6 months) of alcohol abuse.
- Currently (or within 30 days before the planned start of treatment) receiving an investigational drug or using an experimental medical device.
- Homeless.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, 89128
AVIDA, Inc.
Newport Beach, California, 92660
About this study
Official title: A Randomized, Double-blind Study of the Time Course of Response of PRC-063 in Adults With ADHD in a Simulated Adult Workplace Environment
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.
Read the detailed description
This is a randomized, double-blind, crossover, placebo-controlled, optimized-dose, phase 3 study to evaluate the safety and efficacy of PRC-063 (methylphenidate hydrochloride controlled-release capsules 25, 35, 45, 55, 70, 85 or 100 mg/day) in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adult subjects greater than or equal to 18 years of age and less than or equal to 60 years of age. After giving written informed consent, subjects will be screened to ascertain their suitability for the study according to the inclusion and exclusion criteria. The study will have four phases: (1) Screening and subsequent washout, if needed; (2) baseline and open-label dose optimization during which subjects will be titrated from a starting dose of 25 mg up to his/her final dose (25, 35, 45, 55, 70, 85 or 100 mg/day); (3) AWE sessions 1 and 2 in the adult analog setting following a practice session; and (4) 14-day safety follow-up. Subjects will be required to visit the clinic up to 10 times over a 9-week period.
- Being tested
- PRC-063 25 mg, Placebo, PRC-063 35 mg, PRC-063 45 mg, PRC-063 55 mg
- Keywords
- ADHD, Adult
- 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-063 25 mgDrug
Also called 25 mg capsule
Oral 25 mg capsule - active
PlaceboDrug
Also called Placebo capsule
Oral placebo capsule
PRC-063 35 mgDrug
Also called 35 mg capsule
Oral 35 mg capsule - active
PRC-063 45 mgDrug
Also called 45 mg capsule
Oral 45 mg capsule - active
PRC-063 55 mgDrug
Also called 55 mg capsule
Oral 55 mg capsule - active
PRC-063 70 mgDrug
Also called 70 mg capsule
Oral 70 mg capsule - active
PRC-063 85 mgDrug
Also called 85 mg capsule
Oral 85 mg capsule - active
PRC-063 100 mgDrug
Also called 100 mg capsule
Oral 100 mg capsule - active
| Study group | Role | What they receive |
|---|---|---|
| PRC-063 | Active comparator | Not described Receives: Drug: PRC-063 25 mg; Drug: Placebo; Drug: PRC-063 35 mg; Drug: PRC-063 45 mg; Drug: PRC-063 55 mg; Drug: PRC-063 70 mg; Drug: PRC-063 85 mg; Drug: PRC-063 100 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: PRC-063 25 mg; Drug: Placebo; Drug: PRC-063 35 mg; Drug: PRC-063 45 mg; Drug: PRC-063 55 mg; Drug: PRC-063 70 mg; Drug: PRC-063 85 mg; Drug: PRC-063 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Permanent Product Measure of Performance (PERMP)
Measured: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
Secondary outcomes (6)
Observer-rated SKAMP
Measured: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
Clinician-administered ADHD-5-Rating Scale
Measured: 12.0 hours post-dose
Clinical Global Impressions of Improvement (CGI-I)
Measured: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
Subject-rated Conners' Adult ADHD Rating Scale (CAARS)
Measured: 12.0 hours post-dose
Self-report of the Pittsburgh Sleep Quality Index (PSQI)
Measured: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
Patient Satisfaction Survey (PSS)
Measured: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225639
- Sponsor's protocol ID
- 063-008
- Status last verified
- Jul 2015
- First submitted
- 22 Aug 2014
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study of the Time Course of Response of PRC-063 in Adults With ADHD in a Simulated Adult Workplace Environment
- ClinicalTrials.gov ID
- NCT02225639
- Acronym / sponsor ID
- 063-008
- Keywords
- ADHD, Adult
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Aug 2014 (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 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.
Detailed description
This is a randomized, double-blind, crossover, placebo-controlled, optimized-dose, phase 3 study to evaluate the safety and efficacy of PRC-063 (methylphenidate hydrochloride controlled-release capsules 25, 35, 45, 55, 70, 85 or 100 mg/day) in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adult subjects greater than or equal to 18 years of age and less than or equal to 60 years of age. After giving written informed consent, subjects will be screened to ascertain their suitability for the study according to the inclusion and exclusion criteria. The study will have four phases: (1) Screening and subsequent washout, if needed; (2) baseline and open-label dose optimization during which subjects will be titrated from a starting dose of 25 mg up to his/her final dose (25, 35, 45, 55, 70, 85 or 100 mg/day); (3) AWE sessions 1 and 2 in the adult analog setting following a practice session; and (4) 14-day safety follow-up. Subjects will be required to visit the clinic up to 10 times over a 9-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRC-063 | Active comparator | Drug: PRC-063 25 mg, Drug: Placebo, Drug: PRC-063 35 mg, Drug: PRC-063 45 mg, Drug: PRC-063 55 mg, Drug: PRC-063 70 mg, Drug: PRC-063 85 mg, Drug: PRC-063 100 mg |
| Placebo | Placebo comparator | Drug: PRC-063 25 mg, Drug: Placebo, Drug: PRC-063 35 mg, Drug: PRC-063 45 mg, Drug: PRC-063 55 mg, Drug: PRC-063 70 mg, Drug: PRC-063 85 mg, Drug: PRC-063 100 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Must be male or non-pregnant female at least 18 years of age and less than or equal to 60 years of age.
- Must have an ADHD diagnosis, in attentive, hyperactive/impulsive or combined, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) based on clinician assessment using multiple informants and a structured interview.
- Clinician-completed ADHD-5-RS total score must be equal to or greater than 24, as assessed at Visit 2a.
- Must be unsatisfied 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.
- Female subjects must be one of the following: a. surgically sterile prior to screening; b. if of childbearing potential, abstinent or willing to use a reliable method of contraception, such as oral contraceptive, two barrier methods, a barrier method plus a spermicidal agent.
Key exclusion criteria (15 listed)
- Having an allergy to methylphenidate or amphetamines or a history of serious adverse reactions to methylphenidate.
- Known to be non-responsive to methylphenidate treatment. Non-response is defined as methylphenidate 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.
- Being diagnosed with or having a history of strokes, epilepsy, migraine headaches (greater than 1 instance every two months), glaucoma, thyrotoxicosis, tachyarrhythmias or severe angina pectoris or have serious or unstable medical illness. Subjects with controlled or stable asthma or diabetes will be permitted.
- Elevated blood pressure, defined as any values above 89 diastolic or 139 systolic, as assessed at Visit 1.
- Clinically significant ECG abnormalities, as assessed at Visit 1.
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-063 25 mgAlso: 25 mg capsuleOral 25 mg capsule - active | Drug | PRC-063, Placebo |
| PlaceboAlso: Placebo capsuleOral placebo capsule | Drug | PRC-063, Placebo |
| PRC-063 35 mgAlso: 35 mg capsuleOral 35 mg capsule - active | Drug | PRC-063, Placebo |
| PRC-063 45 mgAlso: 45 mg capsuleOral 45 mg capsule - active | Drug | PRC-063, Placebo |
| PRC-063 55 mgAlso: 55 mg capsuleOral 55 mg capsule - active | Drug | PRC-063, Placebo |
| PRC-063 70 mgAlso: 70 mg capsuleOral 70 mg capsule - active | Drug | PRC-063, Placebo |
| PRC-063 85 mgAlso: 85 mg capsuleOral 85 mg capsule - active | Drug | PRC-063, Placebo |
| PRC-063 100 mgAlso: 100 mg capsuleOral 100 mg capsule - active | Drug | PRC-063, Placebo |
Primary outcome
Permanent Product Measure of Performance (PERMP)
Time frame: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
6 secondary outcomes
Observer-rated SKAMP
Time frame: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
Clinician-administered ADHD-5-Rating Scale
Time frame: 12.0 hours post-dose
Clinical Global Impressions of Improvement (CGI-I)
Time frame: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
Subject-rated Conners' Adult ADHD Rating Scale (CAARS)
Time frame: 12.0 hours post-dose
Self-report of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
Patient Satisfaction Survey (PSS)
Time frame: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose
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 9 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 25 mg, PRC-063 35 mg and PRC-063 45 mg in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Rhodes Pharmaceuticals, L.P. at 2 sites 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 9 inclusion and 15 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Permanent Product Measure of Performance (PERMP) (time frame: Pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose). 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 9 Jul 2015.