The Efficacy and Safety of PRC-063 in Adult ADHD Patients

Phase 3

Completed

Conditions: ADHD

Interventions: Drug: Placebo
Drug: PRC-063 25 mg
Drug: PRC-063 45 mg
Drug: PRC-063 70 mg
Drug: PRC-063 100 mg

Registration Number: NCT02139124

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 adults with ADHD

Detailed Description: This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group, forced-dose titration in which adult subjects (18 years of age or older) with ADHD will be randomized to PRC-063 (25, 45, 70 or 100 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: 375

Inclusion Criteria

Male or non-pregnant, non-nursing female at least 18 years of age and meeting the local, legal definition of adult.
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

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 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
Placebo	Placebo	Placebo Arm
PRC-063 25 mg	PRC-063 25 mg	PRC-063 25 mg
PRC-063 45 mg	PRC-063 45 mg	PRC-063 45 mg
PRC-063 70 mg	PRC-063 70 mg	PRC-063 70 mg
PRC-063 100 mg	PRC-063 100 mg	PRC-063 100 mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score	4 weeks	Participants were monitored for 4 weeks on treatment (final 2 weeks on stable dose). Clinicians rated subject behavior on the ADHD-5-Rating Scale each week. Primary outcome was based on the final week of treatment. The ADHD-5-RS is an 18-item questionnaire that measures the frequency of ADHD symptoms based on DSM-5 criteria. For each item, clinicians rate how often the behavior is displayed on a scale of 0 (Never or Rarely) to 3 (Very Often). Scores can range from 0 to 54, with lower scores indicating a lower frequency of ADHD symptoms.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (36): Princeton Medical Institute
🇺🇸
Princeton, New Jersey, United States
Clinical Neuroscience Solutions Inc.
🇺🇸
Memphis, Tennessee, United States
Stedman Clinical Trials
🇺🇸
Tampa, Florida, United States
Sarkis Clinical Trials
🇺🇸
Gainesville, Florida, United States
Florida Clinical Research Center
🇺🇸
Maitland, Florida, United States
Advanced Clinical Research
🇺🇸
Boise, Idaho, United States
Orange County Neuro Phychiatry Research Centre
🇺🇸
Orange, California, United States
Wake Research Associates
🇺🇸
Raleigh, North Carolina, United States
FutureSearch Clinical Trials, L.P.
🇺🇸
Austin, Texas, United States
Physiciatric and Behavioral Solutions
🇺🇸
Salt Lake City, Utah, United States
Doctors Jackiewicz Professional Medical Corporation
🇨🇦
Niagara Falls, Ontario, Canada
IPS Research Company
🇺🇸
Oklahoma City, Oklahoma, United States
Westex Clinical Investigations
🇺🇸
Lubbock, Texas, United States
Clinical Neuroscience Solutions
🇺🇸
Orlando, Florida, United States
Synergy Clinical Research
🇺🇸
National City, California, United States
Northwest Clinical Research Center
🇺🇸
Bellevue, Washington, United States
Eastside Therapeutic Resource
🇺🇸
Kirkland, Washington, United States
Medical Research Network
🇺🇸
New York, New York, United States
Diex Research Sherbrooke Inc.
🇨🇦
Sherbrooke, Quebec, Canada
The Kids Clinic
🇨🇦
Whitby, Ontario, Canada
Dr. Margaret Weiss
🇨🇦
Vancouver, British Columbia, Canada
NeuroScience
🇺🇸
Herndon, Virginia, United States
UCLA
🇺🇸
Los Angeles, California, United States
Red Oak Psychiatry Associates
🇺🇸
Houston, Texas, United States
Houston Clinical Trials
🇺🇸
Houston, Texas, United States
University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
Newport Beach Clinical Research Associates, Inc.
🇺🇸
Newport Beach, California, United States
CNS Healthcare Jacksonville
🇺🇸
Jacksonville, Florida, United States
Center for Psychiatry and Behavioral Medicine Inc.
🇺🇸
Las Vegas, Nevada, United States
Sarkis Clinical Research
🇺🇸
Gainesville, Florida, United States
Oregon Center for Clinical Investigation
🇺🇸
Salem, Oregon, United States
Bayou City Research Ltd
🇺🇸
Houston, Texas, United States
Ericksen Research
🇺🇸
Clinton, Utah, United States
Woodstock Research Center at Neuropsychiatric Associates
🇺🇸
Woodstock, Vermont, United States
Dr. Judy van Stralen
🇨🇦
Ottawa, Ontario, Canada
FutureSearch Trials of Dallas, L.P.
🇺🇸
Dallas, Texas, United States