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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Rhodes Pharmaceuticals, L.P.
Sponsor:
Collaborator:
Purdue Pharma (Canada)
Information provided by (Responsible Party):
Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov Identifier:
NCT02168127
First received: June 14, 2014
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
ADHD
Drug: Drug: PRC-063
Drug: PRC-063
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Six-month, Open-label, Multi-center Study of the Safety and Efficacy of PRC-063 in Adults and Adolescents With ADHD

Resource links provided by NLM:


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

Primary Outcome Measures:
  • occurrence of treatment-emergent adverse events [ Time Frame: Within 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinician-administered ADHD-5-Rating Scale [ Time Frame: Within 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: May 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active drug group
PRC-063 - Active methylphenidate hydrochloride extended-release capsules drug group
Drug: Drug: PRC-063
Methylphenidate Hydrochloride Extended-Release Capsules
Other Name: Methylphenidate
Drug: PRC-063
Methylphenidate Hydrochloride Extended-Release Capsules
Other Name: Methylphenidate

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT02168127

Contacts
Contact: Joseph Reiz 905-420-4964 Joseph.Reiz@purdue.ca

  Hide Study Locations
Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: James McGough    310-794-7841    jmcgough@mednet.ucla.edu   
Contact: Jennifer Cowen    310-825-6170    jcowen@mednet.ucla.edu   
Principal Investigator: Michael McGough         
Synergy Clinical Research Recruiting
National City, California, United States, 91950
Contact: Mohammed Bari    619-327-0155    bari@synergysandiego.com   
Contact: Maria DeAlba    619-327-0155 ext 126    dealbam@synergysandiego.com   
Principal Investigator: Mohammed Bari         
Newport Beach Clinical Research Associates, Inc. Active, not recruiting
Newport Beach, California, United States, 92663
Orange County Neuro Phychiatry Research Centre Recruiting
Orange, California, United States, 92868
Contact: Daniel Chueh    714-719-5559    dchueh@ocresearchtrials.com   
Contact: Christian Ortiz    714-547-0600    cortiz@ocresearchtrials.com   
Principal Investigator: Daniel Chueh         
United States, Florida
Florida Clinical Research Center Recruiting
Bradenton, Florida, United States, 34201
Contact: Andrew Cutler    941-747-7900    acutler@flcrc.com   
Contact: Kathy Gloer    941-747-7900    kgloer@flcrc.com   
Principal Investigator: Andrew Cutler         
Sarkis Clinical Research Recruiting
Gainesville, Florida, United States, 32607
Contact: Elias Sarkis    352-332-3858    ok@ehsfamily.com   
Contact: Amanda Cowsert    386-438-9592    Amanda@ehsfamily.com   
Principal Investigator: Elias Sarkis         
Sarkis Clinical Trials Recruiting
Gainesville, Florida, United States, 32607
Contact: Michael Johnson    352-333-0094    drj@ehsfamily.com   
Contact: Melissa Miller    352-333-0094    Melissa@ehsfamily.com   
Principal Investigator: Michael Johnson         
CNS Healthcare Jacksonville Recruiting
Jacksonville, Florida, United States, 32256
Contact: Nandita Joshi    904-281-5757    njoshi@cnshealthcare.com   
Contact: Brett Gellers    904-281-5757    bgellers@cnshealthcare.com   
Principal Investigator: Nandita Joshi         
Florida Clinical Research Center Recruiting
Maitlin, Florida, United States, 32751
Contact: Martin Kane    407-644-1165    mkane@flcrc.com   
Contact: Joanne Northcutt    407-644-1165    sharrison@flcrc.com   
Principal Investigator: Martin Kane         
Clinical Neuroscience Solutions Recruiting
Orlando, Florida, United States, 32806
Contact: Linda Harper    407-425-5100    lharper@cnshealthcare.com   
Contact: Josephine Wheeler    407-425-5100    jwheeler@cnshealthcare.com   
Principal Investigator: Linda Harper         
United States, Idaho
Advanced Clinical Research Recruiting
Boise, Idaho, United States, 83642
Contact: Mark Turner    208-377-8653 ext 105    mturner@acr-research.com   
Contact: Allie Lopez    208-377-8653 ext 105    alopez@acr-research.com   
Principal Investigator: Mark Turner         
United States, Nevada
Center for Psychiatry and Behavioral Medicine Inc. Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Ann Childress    702-838-0742    drann87@aol.com   
Contact: Nivole Schlaft    702-838-0742    nicoleschlaft@gmail.com   
Principal Investigator: Ann Childress         
United States, New York
Medical Research Network Recruiting
New York, New York, United States, 10128
Contact: Michael Liebowitz    212-595-5012    MLiebowitz@MedicalResearchNetwork.com   
Contact: Ann Johnson    212-595-5012 ext 122    ajohnson@MedicalResearchNetwork.com   
Principal Investigator: Michael Liebowitz         
United States, North Carolina
Wake Research Associates Active, not recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Caleb Adler    513-558-3362    caleb.adler@uc.edu   
Contact: Elizabeth Picard    513-558-3191    picardeh@ucmail.uc.edu   
Principal Investigator: Caleb Adler         
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Melissa DelBello    513-558-4489    melissa.delbello@uc.edu   
Contact: Elizabeth Picard    513-558-3191    picardeh@ucmail.uc.edu   
Principal Investigator: Melissa DelBello         
United States, Oklahoma
IPS Research Company Recruiting
Oklahoma City, Oklahoma, United States, 73103
Contact: Louise Thurman    405-235-5585    flee@ipsresearch.com   
Contact: Fred Lee    405-235-8188    flee@ipsresearch.com   
Principal Investigator: Louise Thurman         
United States, Oregon
Oregon Center for Clinical Investigation Recruiting
Portland, Oregon, United States, 92714
Contact: Beal Essink    503-276-6224    Portland@occi.org   
Contact: Julie Brownsberger    503-276-6224    julie.brownsberger@occi.org   
Principal Investigator: Beal Essink         
Oregon Center for Clinical Investigation Recruiting
Salem, Oregon, United States, 97301
Contact: Alexander Horwitz    503-540-0300    Salem@occi.org   
Contact: Kristine Kowalski    503-540-0100    kristine.kowalski@occi.org   
Principal Investigator: Alexander Horwitz         
United States, Tennessee
Clinical Neuroscience Solutions Inc. Recruiting
Memphis, Tennessee, United States, 38105
Contact: Valerie Arnold    901-843-1045    varnold@cnshealthcare.com   
Contact: Jason Bain    901-843-1045    jbain@cnshealthcare.com   
Principal Investigator: Valerie Arnold         
United States, Texas
FutureSearch Clinical Trials, L.P. Recruiting
Austin, Texas, United States, 78731
Contact: Jesse Loudin    512-380-9925    clinicaltrials@btheodore.com   
Principal Investigator: Donald Garcia         
FutureSearch Trials of Dallas, L.P. Recruiting
Dallas, Texas, United States, 75231
Contact: Stephanie H Dolan    214-369-2600    clinicaltrials@btheodore.com   
Principal Investigator: Michael Downing         
Houston Clinical Trials Recruiting
Houston, Texas, United States, 77098
Contact: Alain Katic    713-665-8787    akatic@houstonclintrials.com   
Contact: Janice Roggenkamp    713-665-8787    jroggenkamp@houstonclintrials.com   
Principal Investigator: Alain Katic         
Red Oak Psychiatry Associates Recruiting
Houston, Texas, United States, 77090
Contact: Lawrence Ginsberg    281-893-4111    larrydg@earthlink.net   
Contact: Michele Sprainis    281-893-4111 ext 155    ropa3@earthlink.net   
Principal Investigator: Lawrence Ginsberg         
Westex Clinical Investigations Recruiting
Lubbock, Texas, United States, 79423
Contact: John Turnbow    806-241-5178    westex.turnbow@hotmail.com   
Contact: Sean Turnbow    806-241-5178    westex.turnbow@hotmail.com   
Principal Investigator: John Turnbow         
United States, Utah
Ericksen Research Recruiting
Clinton, Utah, United States, 84015
Contact: Samantha Bostrom    801-721-6393    medicalway@aol.com   
Contact: Amy Kenley    801-614-5501    amy-kim@westsidemedical.org   
Principal Investigator: Samantha Bostrom         
Physiciatric and Behavioral Solutions Recruiting
Salt Lake City, Utah, United States, 84105
Contact: Frederick Reimherr    801-467-1200    fred.reimherr@hsc.utah.edu   
Contact: Melissa Wilson    801-467-1200    melissaw@pb-solutions.net   
Principal Investigator: Frederick Reimherr         
United States, Vermont
Woodstock Research Center at Neuropsychiatric Associates Recruiting
Woodstock, Vermont, United States, 05091
Contact: Alicia Groft    802-457-4904 ext 102    agroft@npavt.org   
Contact: Mary Edwards    802-457-4904 ext 101    medwards@npavt.org   
Principal Investigator: Alicia Groft         
United States, Virginia
NeuroScience Recruiting
Herndon, Virginia, United States, 20170
Contact: Keith Saylor    703-787-9090    ksaylor@neuroscience-inc.com   
Contact: LuAnn Slough    703-787-9090    laslough@neuroscience-inc.com   
Principal Investigator: Keith Saylor         
United States, Washington
Northwest Clinical Research Center Recruiting
Bellvue, Washington, United States, 98007
Contact: Arif Khan    425-453-0404    akhan@nwcrc.net   
Contact: Christine Khan    425-453-0404    ckhan@nwcrc.net   
Principal Investigator: Arif Khan         
Eastside Therapeutic Resource Recruiting
Kirkland, Washington, United States, 98033
Contact: James Knutson    425-443-9551    drjames.knutson@etresource.com   
Contact: Mary Golescu    425-443-9551    Mary.golescu@etresource.com   
Principal Investigator: James Knutson         
Canada, British Columbia
Dr. Margaret Weiss Recruiting
Vancouver, British Columbia, Canada, V7V 3R8
Contact: Margaret Weiss, Dr.         
Canada, Ontario
Doctors Jackiewicz Professional Medical Corporation Recruiting
Niagara Falls, Ontario, Canada, L2E 6A4
Contact: Grazyna Jackiewicz, Dr.         
Dr. Judy van Stralen Recruiting
Ottawa, Ontario, Canada, K2G 1W2
Contact: Judy van Stralen, Dr.         
The Kids Clinic Recruiting
Whitby, Ontario, Canada, L1N 2L1
Contact: Sohail Khattak, Dr.         
Canada, Quebec
Diex Research Sherbrooke Inc. Recruiting
Sherbrooke, Quebec, Canada, J1H 1Z1
Contact: Angelo Fallu, Dr.         
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: NCT02168127     History of Changes
Other Study ID Numbers: 063-012
Study First Received: June 14, 2014
Last Updated: October 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014