PRC-063 in Adolescent ADHD

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Rhodes Pharmaceuticals, L.P.
Sponsor:
Collaborator:
Purdue Pharma (Canada)
Information provided by (Responsible Party):
Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov Identifier:
NCT02139111
First received: May 12, 2014
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
ADHD
Drug: Placebo
Drug: PRC-063 25 mg
Drug: PRC-063 45 mg
Drug: PRC-063 70 mg
Drug: PRC-063 85 mg
Phase 3

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

Further study details as provided by Rhodes Pharmaceuticals, L.P.:

Primary Outcome Measures:
  • Change from Baseline in Clinician-administered ADHD-5-Rating Scale [ Time Frame: Baseline week 2, weeks 3-6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: April 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Arm
Drug: Placebo
Oral placebo capsule
Other Name: Placebo capsule
Active Comparator: PRC-063 25 mg and Placebo
PRC-063 25 mg and placebo capsule by mouth once daily
Drug: Placebo
Oral placebo capsule
Other Name: Placebo capsule
Drug: PRC-063 25 mg
Oral 25 mg capsule - active
Other Name: 25 mg capsule
Active Comparator: PRC-063 45 mg and Placebo
PRC-063 45 mg and placebo capsule by mouth once daily
Drug: Placebo
Oral placebo capsule
Other Name: Placebo capsule
Drug: PRC-063 45 mg
Oral 45 mg capsule - active
Other Name: 45 mg capsule
Active Comparator: PRC-063 70 mg and Placebo
PRC-063 70 mg and placebo capsule by mouth once daily
Drug: Placebo
Oral placebo capsule
Other Name: Placebo capsule
Drug: PRC-063 70 mg
Oral 70 mg capsule - active
Other Name: 70 mg capsule
Active Comparator: PRC-063 85 mg and Placebo
PRC-063 85 mg and placebo capsule by mouth once daily
Drug: Placebo
Oral placebo capsule
Other Name: Placebo capsule
Drug: PRC-063 85 mg
Oral 85 mg capsule - active
Other Name: 85 mg capsule

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  • 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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02139111

Contacts
Contact: Joseph Reiz 905-402-4964 Joseph.Reiz@purdue.ca

  Show 42 Study Locations
Sponsors and Collaborators
Rhodes Pharmaceuticals, L.P.
Purdue Pharma (Canada)
Investigators
Study Director: Joseph Reiz Purdue Pharma
  More Information

No publications provided

Responsible Party: Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov Identifier: NCT02139111     History of Changes
Other Study ID Numbers: 063-009
Study First Received: May 12, 2014
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 15, 2014