PRC-063 in Adolescent ADHD

ADHD Clinical Trial

Official title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adolescent ADHD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139111
• Other study ID #: 063-009
• Status: Completed
• Phase: Phase 3
• First received: May 12, 2014
• Last updated: July 7, 2015
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Rhodes Pharmaceuticals, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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 ß-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

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 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• 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 85 mg
Oral 85 mg capsule - active

Locations

Country	Name	City	State
Canada	Mathison Centre for Mental Health Research and Education	Calgary	Alberta
Canada	University of Calgary	Calgary	Alberta
Canada	Atlantic ADHD Centre	Dartmouth	Nova Scotia
Canada	Chokka Center for Integrative Health	Edmonton	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Doctors Jackiewicz Professional Medical Corporation	Niagra Falls	Ontario
Canada	Dr. Judy van Stralen	Ottawa	Ontario
Canada	Royal University Hospital Saskatoon	Saskatoon	Saskatchewan
Canada	Stress, Trauma, Anxiety, Rehabilitation and Treatment (START) in the Mood and Anxiety Disorders Clinic	Toronto	Ontario
Canada	Dr. Margaret Weiss	Vancouver	British Columbia
Canada	The Kids Clinic	Whitby	Ontario
United States	FutureSearch Clinical Trials, L.P.	Austin	Texas
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellvue	Washington
United States	Advanced Clinical Research	Boise	Idaho
United States	Florida Clinical Research Center	Bradenton	Florida
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ericksen Research	Clinton	Utah
United States	FutureSearch Trials of Dallas, L.P.	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Sarkis Clinical Research	Gainesville	Florida
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	NeuroScience	Herndon	Virginia
United States	Bayou City Research Ltd	Houston	Texas
United States	Houston Clinical Trials	Houston	Texas
United States	Red Oak Psychiatry Associates	Houston	Texas
United States	CNS Healthcare Jacksonville	Jacksonville	Florida
United States	Eastside Therapeutic Resource	Kirkland	Washington
United States	Center for Psychiatry and Behavioral Medicine Inc.	Las Vegas	Nevada
United States	UCLA	Los Angeles	California
United States	Florida Clinical Research Center	Maitlin	Florida
United States	Clinical Neuroscience Solutions Inc.	Memphis	Tennessee
United States	Synergy Clinical Research	National City	California
United States	Newport Beach Clinical Research Associates, Inc.	Newport Beach	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Orange County Neuro Phychiatry Research Centre	Orange	California
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	Wake Research Associates	Raleigh	North Carolina
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	Miami Research Associates	South Miami	Florida
United States	Stedman Clinical Trials	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Rhodes Pharmaceuticals, L.P.	Purdue Pharma LP

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Clinician-administered ADHD-5-Rating Scale		Baseline week 2, weeks 3-6	No