Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Lisdexamfetamine dimesylate
Intervention description: Optimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 314.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: ADHD

Summary:

      While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy,
      safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and
      adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have
      been of short duration - up to 8 weeks.

      A number of long-term studies have been undertaken (up to 1 year) and these have confirmed
      the safety and ongoing efficacy in this patient population.

      In order to run a study with investigational medication within Poland the study changed to a
      Phase 3 rather than a Phase 4 study in that country. Please note that the study number
      remains as SPD489-404.

      Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in
      children and adolescents over a 2-year treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

        For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489
        326):

          -  Subject is a male or female aged 6-17 years.

          -  Subject participated in SPD489-317, completed 9 weeks of treatment, and completed the
             1 week post-treatment safety follow-up visit.

        For subjects who have not participated in another SPD489 study:

          -  Subject is a male or female aged 6-17 years.

          -  Subject must meet DSM-IV-TR criteria for a primary diagnosis of ADHD based on a
             detailed psychiatric evaluation.

        For all subjects:

          -  Subject has a Baseline ADHD-RS-IV total score greater than or equal to 28.

          -  Subject, who is female of childbearing potential (FOCP), must have a negative serum
             beta Human Chorionic Gonadotropin (HCG) pregnancy test, and a negative urine pregnancy
             test at Baseline, be non-lactating and agree to comply with any applicable
             contraceptive requirements of the protocol.

          -  Subject and parent/LAR are willing and able to comply with all the testing and
             requirements defined, including oversight of morning dosing. Specifically, the
             parent/LAR must be available upon awakening, at approximately 7:00 AM, to dispense the
             dose of Investigational Product for the duration of the study.

          -  Subject aged greater than or equal to 18 years has a systolic blood pressure less than
             or equal to 139 mmHg and a diastolic blood pressure less than or equal to 89 mmHg.

          -  Subject is able to swallow a capsule.

        Exclusion Criteria:

        For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489
        326):

          -  Subject was terminated from a previous SPD489 study (SPD489-325 or SPD489 326) for
             protocol non-adherence and/or subject non-compliance and/or experienced a
             medication-related SAE or AE resulting in termination from the previous study.

          -  Subject experienced any clinically significant AEs in a prior SPD489 study (SPD489
             317, SPD489-325, or SPD489-326) that, in the opinion of the Investigator, would
             preclude further exposure to SPD489.

        For all subjects:

          -  Subject's symptoms are well-controlled on their currently prescribed ADHD medication
             with acceptable tolerability.

          -  Subject has a positive urine drug result at Screening.

          -  Subject has a current, controlled (requiring a restricted medication) or uncontrolled,
             comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid
             Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder,
             psychosis, bipolar illness, pervasive developmental disorder, severe obsessive
             compulsive disorder, severe depressive or severe anxiety disorder) or other
             symptomatic manifestations, such as agitated states, marked anxiety, or tension.

          -  Subject has taken another Investigational Product or taken part in a clinical study
             with the exception of a prior SPD489 study (SPD489-317, SPD489 325, or SPD489 326)
             within 30 days prior to Screening.

          -  Subject weighs less than 22.7 kg (50 lbs).

          -  Subject is significantly overweight.

          -  Subject has a conduct disorder. Oppositional defiant disorder is not exclusionary.

          -  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 conducted in the study or that might
             increase risk to the subject.

          -  Subject is currently considered a suicide risk in the opinion of the Investigator, has
             previously made a suicide attempt, or has a prior history of, or is currently
             demonstrating active suicidal ideation. Subjects with intermittent passive suicidal
             ideation are not necessarily excluded based on the assessment of the Investigator

          -  Subject has glaucoma.

          -  Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating
             hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication
             for at least 3 months is permitted.

          -  Subject has any clinically significant ECG abnormality.

          -  Subject has any clinically significant laboratory abnormalities.

          -  Subject has a documented allergy, hypersensitivity, or intolerance to any active
             ingredient or excipients in SPD489.

          -  Subject has a recent history (within the past 6 months) of suspected substance abuse
             or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.

          -  Subject has a history of seizures (other than infantile febrile seizures), a chronic
             or current tic disorder, a current diagnosis of Tourette's Disorder, or a known family
             history of Tourette's Disorder. Subject has a history of tics that is judged by the
             Investigator to be exclusionary.

          -  Subject has a known history of symptomatic cardiovascular or cerebrovascular disease,
             advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious
             heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems
             that may place them at increased vulnerability to the sympathomimetic effects of a
             stimulant drug.

          -  Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

          -  Subject has a medical condition, other than ADHD, that requires treatment with
             medications that have central nervous system effects and/or affect performance. Stable
             use of anticholinergic or theophylline bronchodilators is not exclusionary.