Attention Deficit/Hyperactivity Disorder (ADHD) MedDRA version: 14.1 Level: LLT Classification code 10064104 Term: ADHD System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Vyvanse
Product Name: Lisdexamfetamine dimesylate (LDX)
Product Code: SPD489
Pharmaceutical Form: Capsule, hard
INN or Propo
Sponsors
Shire Pharmaceutical Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489-326): 1. Subject is a male or female aged 6-17 years inclusive at the time of consent for the previous SPD489 study (SPD489-317, SPD489-325, or SPD489-326). 2. For sites where Study SPD489-326 (12-month open-label or randomised withdrawal design) was not available at the time of subject’s final visit in Study SPD489-325, subject satisfied all entry criteria for the antecedent study (SPD489-325), completed a minimum of 4 weeks of double-blind treatment, reached Visit 4, and completed the 1-week post-treatment washout in SPD489-325. 3. For sites where Study SPD489-326 study (12-month open-label design) was available at the time of subject’s final visit in Study SPD489-325, subject satisfied all entry criteria and was enrolled in the antecedent study (SPD489-326). 4. For sites where Study SPD489-326 (randomised withdrawal design) was available at the time of subject’s final visit in Study SPD489-325, subject satisfied all entry criteria for the antecedent study (SPD489-326), and either completed the post-treatment follow-up call/visit or was withdrawn from the study during the randomisation withdrawal period due to meeting relapse criteria in the antecedent study (SPD489-326). 5. Subject participated in SPD489-317, completed 9 weeks of treatment, and completed the 1-week post-treatment safety follow-up visit. 6. Subject participated in a prior SPD489 study (SPD489-317, SPD489-325, or SPD489-326) and had a gap in participation (eg, >7 days) between exiting the previous study and entering this study. The subject’s ADHD-RS-IV total score at Study SPD489-404 Baseline (Visit 0) must be =28. For subjects who have not participated in another SPD489 study: 7. Subject is a male or female aged 6-17 years inclusive at the time of consent. 8. Subject must meet DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation. 9. Subject has a Baseline (Visit 0) ADHD-RS-IV total score =28. For all subjects: 10. Subject, who is female of childbearing potential (FOCP), must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening (Visit –1), and a negative urine pregnancy test at Baseline (Visit 0), be non-lactating and agree to comply with any applicable contraceptive requirements of the protocol (See Section 4.3). 11. Subject’s parent or legally authorised representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Conference on Harmonisation (ICH) GCP Guideline E6 (1996) and applicable regulations, before completing any study-related procedures. 12. Subject and parent/LAR are willing and able to comply with all the testing and requirements defined in this protocol, including oversight of morning dosing. Specifically, the parent/LAR must be available upon awakening, at approximately 7:00AM, to dispense the dose of Inves
Exclusion criteria
Exclusion criteria: For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489-326): 1. 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 or other symptomatic manifestations, such as agitated states, marked anxiety or tension. 2. Subject was terminated from a previous SPD489 study for protocol non-adherence and/or subject non-compliance and/or experienced an SAE or AE resulting in termination from the previous study. 3. Subject experienced any clinically significant AEs in a prior SPD489 study 4. Subject participated in a prior SPD489 study, had a gap in participation (eg, >7 days between exiting the previous study and entering this study), and has a positive urine drug result at Screening 5. Subject participated in a prior SPD489 study, had a gap in participation (eg, >7 days between exiting the previous study and entering this study), and has taken another Investigational Product or taken part in another clinical trial within 30 days prior to Screening (Visit –1). For subjects who have not participated in another SPD489 study: 6. Subject has a positive urine drug result at Screening, with the exception of the subject’s current ADHD therapy. 7. 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 or other symptomatic manifestations, such as agitated states, marked anxiety, or tension. 8. Subject has taken another Investigational Product or taken part in a clinical study within 30 days prior to Screening (Visit –1). For all subjects: 9. Subject weighs <22.7kg (50lbs) or is significantly underweight based on World Health Organization Body Mass Index (BMI)-for-age sex-specific charts at Screening (Visit –1). 10. Subject has a conduct disorder. 11. 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. 12. 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. 13. Subject has glaucoma. 14. Subject is significantly overweight based on World Health Organization Body Mass Index (BMI)-for-age and sex-specific charts at Screening (Visit –1). 15. Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4) at Screening (Visit –1). Treatment with a stable dose of thyroid medication for at least 3 months is permitted. 16. Subject has any clinically significant ECG at Screening (Visit –1) or Baseline (Visit 0). 17. Subject has any clinically significant laboratory abnormalities at Screening (Visit –1
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. ADHD-RS-IV total score as well as the Hyperactivity/Impulsivity and Inattention subscale scores 2. The CGI-I and CGI-S ;Timepoint(s) of evaluation of this end point: Each applicable post-baseline visit until last visit on treatment | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety of SPD489 administered as a daily morning dose (30, 50, and 70mg) in the treatment of children and adolescents (6-17 years of age inclusive at the time of consent in this study or a previous SPD489 study (SPD489-317, SPD489-325, or SPD489-326) diagnosed with moderately to severely symptomatic ADHD. ; Secondary Objective: 1. To assess the long-term efficacy of SPD489 using the clinician-administered ADHD-rating scale-IV (ADHD-RS-IV) total score and hyperactivity/impulsivity and inattentiveness subscale scores. 2. To assess the long-term efficacy of SPD489 using global clinical measures of severity and improvement as measured by the Clinical Global Impressions – Severity of Illness (CGI-S) and Clinical Global Impressions – Global Improvement (CGI-I). ;Primary end point(s): The primary endpoint of this study is the long-term safety of SPD489.;Timepoint(s) of evaluation of this end point: TEAEs: from the start of treatment to 3 days after cessation. Others: at each applicable post-baseline visit. | — |
Countries
Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactMedical Communications
Shire Pharmaceutical Development Ltd
Outcome results
None listed