PRC-063 in Adolescent ADHD
- Conditions
- ADHD
- Interventions
- Drug: PlaceboDrug: PRC-063 25 mgDrug: PRC-063 45 mgDrug: PRC-063 70 mgDrug: PRC-063 85 mg
- Registration Number
- NCT02139111
- Lead Sponsor
- Rhodes Pharmaceuticals, L.P.
- Brief Summary
The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD.
- Detailed Description
This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group, forced-dose titration in which adolescent subjects (12 to 17 years of age inclusive) with ADHD will be randomized to PRC-063 (25, 45, 70 or 85 mg) or placebo for four weeks of double-blind evaluation of safety and efficacy. The study will have four phases: (1) screening and 1-week washout; (2)baseline and double-blind, forced-dose titration over a 2-week period; (3) double-blind evaluation over a 2-week period; and (4) a 14-day safety follow-up. Subjects will be required to visit the site 6 times over a 5 week period.
Screening and Washout: Subjects will be screened to establish eligibility for study participation. Subjects who meet eligibility requirements will undergo ADHD medication washout, if applicable.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- Must be male or non-pregnant female at least 12 years of age and less than 18 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.
- 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.
- Must have a minimum level of intellectual functioning, as determined by an Intelligence Quotient (IQ) score of 80 or above based on the WASI or the KBIT.
- 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 85 mg capsule.
- Total score of 24 or greater on the clinician-rated ADHA-5-RS, as assessed at Visit 2
- 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.
- 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.
- 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 (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRC-063 70 mg and Placebo Placebo PRC-063 70 mg and placebo capsule by mouth once daily Placebo Placebo Placebo Arm PRC-063 25 mg and Placebo Placebo PRC-063 25 mg and placebo capsule by mouth once daily PRC-063 25 mg and Placebo PRC-063 25 mg PRC-063 25 mg and placebo capsule by mouth once daily PRC-063 45 mg and Placebo Placebo PRC-063 45 mg and placebo capsule by mouth once daily PRC-063 45 mg and Placebo PRC-063 45 mg PRC-063 45 mg and placebo capsule by mouth once daily PRC-063 70 mg and Placebo PRC-063 70 mg PRC-063 70 mg and placebo capsule by mouth once daily PRC-063 85 mg and Placebo Placebo PRC-063 85 mg and placebo capsule by mouth once daily PRC-063 85 mg and Placebo PRC-063 85 mg PRC-063 85 mg and placebo capsule by mouth once daily
- Primary Outcome Measures
Name Time Method Change from Baseline in Clinician-administered ADHD-5-Rating Scale Baseline week 2, weeks 3-6
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (42)
Advanced Clinical Research
🇺🇸Boise, Idaho, United States
Red Oak Psychiatry Associates
🇺🇸Houston, Texas, United States
Houston Clinical Trials
🇺🇸Houston, Texas, United States
Center for Psychiatry and Behavioral Medicine Inc.
🇺🇸Las Vegas, Nevada, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Stress, Trauma, Anxiety, Rehabilitation and Treatment (START) in the Mood and Anxiety Disorders Clinic
🇨🇦Toronto, Ontario, Canada
Newport Beach Clinical Research Associates, Inc.
🇺🇸Newport Beach, California, United States
Orange County Neuro Phychiatry Research Centre
🇺🇸Orange, California, United States
Kennedy Krieger Institute
🇺🇸Baltimore, Maryland, United States
Sarkis Clinical Research
🇺🇸Gainesville, Florida, United States
Bayou City Research Ltd
🇺🇸Houston, Texas, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Memphis, Tennessee, United States
FutureSearch Clinical Trials, L.P.
🇺🇸Austin, Texas, United States
Ericksen Research
🇺🇸Clinton, Utah, United States
Eastside Therapeutic Resource
🇺🇸Kirkland, Washington, United States
NeuroScience
🇺🇸Herndon, Virginia, United States
Mathison Centre for Mental Health Research and Education
🇨🇦Calgary, Alberta, Canada
Northwest Clinical Research Center
🇺🇸Bellvue, Washington, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
UCLA
🇺🇸Los Angeles, California, United States
Synergy Clinical Research
🇺🇸National City, California, United States
Florida Clinical Research Center
🇺🇸Maitlin, Florida, United States
CNS Healthcare Jacksonville
🇺🇸Jacksonville, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
FutureSearch Trials of Dallas, L.P.
🇺🇸Dallas, Texas, United States
Physiciatric and Behavioral Solutions
🇺🇸Salt Lake City, Utah, United States
The University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Chokka Center for Integrative Health
🇨🇦Edmonton, Alberta, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
Doctors Jackiewicz Professional Medical Corporation
🇨🇦Niagra Falls, Ontario, Canada
Royal University Hospital Saskatoon
🇨🇦Saskatoon, Saskatchewan, Canada
Dr. Margaret Weiss
🇨🇦Vancouver, British Columbia, Canada
The Kids Clinic
🇨🇦Whitby, Ontario, Canada
Dr. Judy van Stralen
🇨🇦Ottawa, Ontario, Canada
Miami Research Associates
🇺🇸South Miami, Florida, United States
Atlantic ADHD Centre
🇨🇦Dartmouth, Nova Scotia, Canada
McMaster University
🇨🇦Hamilton, Ontario, Canada