Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
Condition: ADHD
Intervention: Methylphenidate Transdermal System
Intervention description: One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17
      years diagnosed withADHD
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for inclusion, each subject must fulfill each of the following criteria at
        the Entry visit:

          -  The subject participated in the antecedent SPD485-409 study, and a) completed all
             required study visits (Baseline through Visit 9) OR b) completed the 5 week Dose
             Optimization period without achieving an acceptable condition as defined by the
             antecedent SPD485-409 study.

          -  Subject has blood pressure measurements within the 95th percentile for age, gender,
             and height at Entry.

          -  Subject's ECG results are within the normal range or not clinically significant at
             Entry as judged by the Investigator in conjunction with the central reader.

          -  Females must have a negative urine pregnancy test at Entry and agree to use acceptable
             contraceptives throughout the study period and for 30 days the last dose of IP.

          -  Subject and parent of legally authorized representative (LAR) are able, willing and
             likely to fully comply with study procedures and restrictions.

          -  Written, signed and dated informed consent to participate in the study must be given
             by the subject's parent or LAR, in accordance with the International Conference on
             Harmonisation (ICH), Good Clinical Practices (GCP) Guideline E6 and applicable
             regulations, before completing any study-related procedures.

          -  There must be documentation of the subject's assent to participate in the study
             indicating that the subject is aware of the investigational nature of the study and
             the required procedures and restrictions. Failure to object is not to be considered
             assent.

        Exclusion Criteria

        Subjects will be excluded from the study if any of the following criteria are met at Entry:

          -  Subject was discontinued from SPD485-409 due to a protocol violation, non-compliance,
             AE, or a serious adverse event (SAE).

          -  Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or
             an infectious process requiring antibiotics), disability, or other condition that
             might confound the results of safety assessments administered in the study or that
             might increase risk to the subject. Similarly, the subject will be excluded if he or
             she has any additional condition(s) that in the Investigator's opinion would prohibit
             the subject from completing the study or would not be in the best interest of the
             subject. This would include any significant illness or unstable medical condition that
             could lead to difficulty complying with the protocol. Mild, stable asthma is not
             exclusionary.

          -  Subject is taking any medication that is excluded.

          -  Female subject who is pregnant or lactating.