The Efficacy and Safety of PRC-063 in Adult ADHD Patients
NCT ID: NCT02139124
Last Updated: 2019-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
375 participants
INTERVENTIONAL
2014-04-30
2015-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo Arm
Placebo
Oral placebo capsule
PRC-063 25 mg
PRC-063 25 mg
PRC-063 25 mg
Oral 25 mg capsule - active
PRC-063 45 mg
PRC-063 45 mg
PRC-063 45 mg
Oral 45 mg capsule - active
PRC-063 70 mg
PRC-063 70 mg
PRC-063 70 mg
Oral 70 mg capsule - active
PRC-063 100 mg
PRC-063 100 mg
PRC-063 100 mg
Oral 100 mg capsule - active
Interventions
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Placebo
Oral placebo capsule
PRC-063 25 mg
Oral 25 mg capsule - active
PRC-063 45 mg
Oral 45 mg capsule - active
PRC-063 70 mg
Oral 70 mg capsule - active
PRC-063 100 mg
Oral 100 mg capsule - active
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 multiple informants and a structured interview.
* 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.
postmenopausal; c. 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 have a negative serum β-hCG pregnancy test at screening.
* Minimum level of intellectual functioning, as determined by an Intelligence Quotient (IQ) score of 80 or above based on the WASI.
* Mentally and physically competent to sign an informed consent document 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.
Exclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Purdue Pharma, Canada
INDUSTRY
Rhodes Pharmaceuticals, L.P.
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Reiz
Role: STUDY_DIRECTOR
Purdue Pharma LP
Locations
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UCLA
Los Angeles, California, United States
Synergy Clinical Research
National City, California, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, United States
Orange County Neuro Phychiatry Research Centre
Orange, California, United States
Florida Clinical Research Center
Bradenton, Florida, United States
Sarkis Clinical Research
Gainesville, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
CNS Healthcare Jacksonville
Jacksonville, Florida, United States
Florida Clinical Research Center
Maitland, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Advanced Clinical Research
Boise, Idaho, United States
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, United States
Princeton Medical Institute
Princeton, New Jersey, United States
Medical Research Network
New York, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigation
Portland, Oregon, United States
Oregon Center for Clinical Investigation
Salem, Oregon, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States
FutureSearch Clinical Trials, L.P.
Austin, Texas, United States
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, United States
Bayou City Research Ltd
Houston, Texas, United States
Red Oak Psychiatry Associates
Houston, Texas, United States
Houston Clinical Trials
Houston, Texas, United States
Westex Clinical Investigations
Lubbock, Texas, United States
Ericksen Research
Clinton, Utah, United States
Physiciatric and Behavioral Solutions
Salt Lake City, Utah, United States
Woodstock Research Center at Neuropsychiatric Associates
Woodstock, Vermont, United States
NeuroScience
Herndon, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Dr. Margaret Weiss
Vancouver, British Columbia, Canada
Doctors Jackiewicz Professional Medical Corporation
Niagara Falls, Ontario, Canada
Dr. Judy van Stralen
Ottawa, Ontario, Canada
The Kids Clinic
Whitby, Ontario, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Countries
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References
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Weiss MD, Surman C, Khullar A, He E, Cataldo M, Donnelly G. Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension. CNS Drugs. 2021 Jun;35(6):667-679. doi: 10.1007/s40263-021-00814-z. Epub 2021 May 31.
Other Identifiers
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063-010
Identifier Type: -
Identifier Source: org_study_id
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