Long-Term Safety of PRC-063 in Adolescents and Adults With ADHD

July 7, 2015 updated by: Rhodes Pharmaceuticals, L.P.

A Six-month, Open-label, Multi-center Study of the Safety and Efficacy of PRC-063 in Adults and Adolescents With ADHD

The purpose of this six month, open-label study is to evaluate the long-term safety and efficacy of PRC-063 in adults and adolescents with ADHD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open label, multicenter, phase 3 study to evaluate the safety and efficacy of PRC-063 (methylphenidate hydrochloride controlled-release capsules 25, 35, 45, 55, 70, 85 or 100 mg/day) in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adolescent subjects aged ≥12 to <18 years of age and adult subjects aged ≥18 years of age. In order to participate, subjects must have completed Purdue Pharma Study 063-009 or Purdue Pharma Study 063-010. This study will be conducted at approximately 50 centers across the United States and Canada. After giving written informed consent (as well as informed assent for subjects <18 years of age), subjects will be screened to ascertain their suitability for the study according to the inclusion and exclusion criteria. There will be seven monthly efficacy and safety visits during which subjects will be assessed on active, open-label PRC-063. The starting dose will be at the discretion of the Investigator. Dose-adjustment visits may occur weekly to optimize the subject's dose via titration. For adolescent subjects, the maximum dose will be 85 mg/day. For adult subjects, the maximum dose will be 100 mg/day.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V7V 3R8
        • Dr. Margaret Weiss
    • Ontario
      • Niagara Falls, Ontario, Canada, L2E 6A4
        • Doctors Jackiewicz Professional Medical Corporation
      • Ottawa, Ontario, Canada, K2G 1W2
        • Dr. Judy van Stralen
      • Whitby, Ontario, Canada, L1N 2L1
        • The Kids Clinic
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • Diex Research Sherbrooke Inc.
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
      • National City, California, United States, 91950
        • Synergy Clinical Research
      • Newport Beach, California, United States, 92663
        • Newport Beach Clinical Research Associates, Inc.
      • Orange, California, United States, 92868
        • Orange County Neuro Phychiatry Research Centre
    • Florida
      • Bradenton, Florida, United States, 34201
        • Florida Clinical Research Center
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Research
      • Jacksonville, Florida, United States, 32256
        • CNS Healthcare Jacksonville
      • Maitlin, Florida, United States, 32751
        • Florida Clinical Research Center
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions
    • Idaho
      • Boise, Idaho, United States, 83642
        • Advanced Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Center for Psychiatry And Behavioral Medicine Inc.
    • New York
      • New York, New York, United States, 10128
        • Medical Research Network
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
    • Oregon
      • Portland, Oregon, United States, 92714
        • Oregon Center for Clinical Investigation
      • Salem, Oregon, United States, 97301
        • Oregon Center for Clinical Investigation
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Clinical Neuroscience Solutions Inc.
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Clinical Trials, L.P.
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, L.P.
      • Houston, Texas, United States, 77098
        • Houston Clinical Trials
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry Associates
      • Lubbock, Texas, United States, 79423
        • Westex Clinical Investigations
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research
      • Salt Lake City, Utah, United States, 84105
        • Physiciatric and Behavioral Solutions
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Woodstock Research Center at Neuropsychiatric Associates
    • Virginia
      • Herndon, Virginia, United States, 20170
        • Neuroscience
    • Washington
      • Bellvue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Kirkland, Washington, United States, 98033
        • Eastside Therapeutic Resource

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study as an adolescent:

• Male or non-pregnant, non-nursing female at least 12 years of age and less than 18 years of age.

Subjects must satisfy the following criteria to be enrolled in the study as an adult:

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

All subjects must also satisfy the following criteria to be enrolled in the study:

  • Confirmation of ADHD diagnosis made at Visit 1 of Study 063-009 or 063-010 (inattentive, hyperactive/impulsive or combined-type, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition based on clinician assessment using multiple informants and a structured interview).
  • Female subjects must be one of the following:
  • Surgically sterile prior to screening
  • Postmenopausal
  • 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, as assessed at Visit 6 of Study 063-009 or 063-010 (data will not be available at the time of entry).
  • If the subject is an adult, 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. If the subject is an adolescent, 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.

Exclusion Criteria:

  • • Having met any exclusion criteria for Study 063-009 or 063-010.

    • Having been diagnosed during Study 063-009 or 063-010 with 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 6 of Study 063-009 or 063-010.
    • Clinically significant ECG abnormalities, as assessed at Visit 6 of Study 063-009 or 063-010 (data will not be available at the time of entry).
    • Clinically significant laboratory abnormalities, as assessed at Visit 6 of Study 063-009 or 063-010 (data will not be available at the time of entry).
    • 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).
    • If the Investigator judges that continued treatment with PRC-063 is not in the subject's best interest.
    • Subjects who are currently considered a suicide risk by the investigator.
    • Having been diagnosed during Study 063-009 or 063-010 with 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.
    • Having been diagnosed during Study 063-009 or 063-010 with physiological dependence (excluding nicotine) on narcotic analgesics or other psychoactive drugs (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines).
    • Excessive consumption of alcohol occurring during Study 063-009 or 063-010 (consumes alcohol in quantities greater than 15 drinks per week on average; 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).
    • Currently (or within 30 days before the planned start of treatment) receiving an investigational drug or using an experimental medical device, other than PRC-063.
    • Homeless.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active drug group
PRC-063 - Active methylphenidate hydrochloride extended-release capsules drug group
Drug: Drug: PRC-063
Methylphenidate Hydrochloride Extended-Release Capsules
Other Names:
  • Methylphenidate
Drug: PRC-063
Methylphenidate Hydrochloride Extended-Release Capsules
Other Names:
  • Methylphenidate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
occurrence of treatment-emergent adverse events
Time Frame: Within 6 months
Within 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinician-administered ADHD-5-Rating Scale
Time Frame: Within 6 months
Within 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhodes Pharmaceuticals, L.P.

Collaborators

Purdue Pharma LP

Investigators

  • Study Director: Joseph Reiz, Purdue Pharma LP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 14, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (Estimate)

June 20, 2014

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 063-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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