ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02704390
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Collaborator:
Durect
Information provided by (Responsible Party):
Orient Pharma Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: ORADUR®-Methylphenidate Phase 3

Detailed Description:
In order to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD, subjects who participated in the previous OP-2PN012-301 study will be invited to join this extension study for 24-month follow-up. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study to Evaluate the Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
Study Start Date : January 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ORADUR®-Methylphenidate
ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months.
Drug: ORADUR®-Methylphenidate
ORADUR®-Methylphenidate is available in three dosage forms, 22 mg, 33 mg or 44 mg. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose for 24 months.




Primary Outcome Measures :
  1. SNAP-IV teacher form scores in ORADUR®-Methylphenidate [ Time Frame: 24 months ]
    Change from baseline of Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form scores


Secondary Outcome Measures :
  1. SNAP-IV parent form scores in ORADUR®-Methylphenidate [ Time Frame: 24 months ]
    Change from baseline of SNAP-IV parent form scores

  2. Remission rate in ORADUR®-Methylphenidate [ Time Frame: 24 months ]
    Remission rate as assessed by SNAP-IV teacher form and SNAP-IV parent form

  3. Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate [ Time Frame: 24 months ]
    Change from baseline of Conners' Continuous Performance Test (CPT-II) performance results

  4. Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate [ Time Frame: 24 months ]
    Change from baseline (screening period) of Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis. During study period, DSM-5 diagnosis will be performed at each visit. Investigator will check the diagnostic classification, the dianostic criteria sets and the descriptive test of DSM-5 questionnaire and confirm the severity of ADHD based on subject's current condition.

  5. Clinical Global Impression-ADHD-Severity (CGI-S) scores in ORADUR®-Methylphenidate [ Time Frame: 24 months ]
    Change from baseline of Clinical Global Impression-ADHD-Severity (CGI-S) scores

  6. Clinical Global Impression-ADHD-Improvement (CGI-I) scores in ORADUR®-Methylphenidate [ Time Frame: 24 months ]
    Change from baseline of Clinical Global Impression-ADHD-Improvement (CGI-I) scores

  7. Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance in ORADUR®-Methylphenidate [ Time Frame: 24 months ]
    Change from baseline of Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance result (at National Taiwan University Hospital, NTUH, only)

  8. Treatment compliance in ORADUR®-Methylphenidate [ Time Frame: 24 months ]
    Evaluate the treatment compliance during study period. Compliance will be assessed by the result of drug accountability and presented by the missing dose rate.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Subjects previously enrolled in OP-2PN012-301 study and completed 4-week study treatment
  2. Both subjects and parents/guardians have provided their signed and dated informed consent form for the study

Main Exclusion Criteria:

  1. Subjects who experienced unmanageable adverse events (AEs) after receiving ORADUR®-Methylphenidate
  2. Subjects are taking a concomitant medication (ex: Monoamine Oxidase Inhibitor (MAOI) or other ADHD treatments) that is likely to interfere with safe administration of methylphenidate within 14 day prior to the study treatment initiation
  3. Subjects are joining other clinical studies and receiving any other investigational medical products within 14 days prior to the study treatment initiation.
  4. By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety
  5. By the investigators' discretion, subjects cannot understand or follow the instructions given in the study
  6. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704390


Contacts
Contact: I-Chan Lee, MS +886-2-2325-7621 ext 2928 ichan.lee@oppharma.com

Locations
Taiwan
Chang Gung Medical Foundation- Chiayi Branch Not yet recruiting
Chiayi, Taiwan
Contact: Chih-Hung Chen, MD         
Principal Investigator: Chih-Hung Chen, MD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Susan Shur-Fen Gau, MD, PhD         
Principal Investigator: Susan Shur-Fen Gau, MD, PhD         
Chang Gung Medical Foundation- Linkuo Branch Recruiting
Taoyuan, Taiwan
Contact: Yu-Shu Huang, MD, PhD         
Principal Investigator: Yu-Shu Huang, MD, PhD         
Sponsors and Collaborators
Orient Pharma Co., Ltd.
Durect
Investigators
Study Director: Chi-Tai Chang, PhD Orient Pharma Co., Ltd.

Responsible Party: Orient Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02704390     History of Changes
Other Study ID Numbers: OP-2PN012-301E
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016

Keywords provided by Orient Pharma Co., Ltd.:
ORADUR®-Methylphenidate

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents