Attention Deficit/Hyperactivity Disorder (ADHD) MedDRA version: 17.0 Level: LLT Classification code 10064104 Term: ADHD System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Intuniv
Product Name: Guanfacine Hydrochloride
Product Code: SPD503
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Guanfacine Hydrochloride
CAS Number: 29110-48-3
Conce
Sponsors
Shire Pharmaceutical Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For subjects enrolling from antecedent Study SPD503-315: Subjects will be eligible if they met the response criteria for entry into Phase 2, were randomized, and completed Phase 2 or withdrew early because the protocol-defined treatment failure criteria was met. For subjects enrolling from antecedent Study SPD503-316: Children age 6-12, regardless of treatment group, must complete 10 weeks of double-blind treatment, reach Visit 15/Final, and complete the 2-week dose taper. Adolescents age 13 and older, regardless of treatment group, must complete 13 weeks of double-blind treatment, reach Visit 15/Final, and complete the 2-week dose taper. For all subjects: 1. For subjects where Study SPD503-318 was not available at the time of subject’s final visit in the antecedent study (SPD503-315 or SPD503-316), subject may still screen unless they are well-controlled on another ADHD medication with acceptable tolerability and the parent/caregiver is satisfied with the current ADHD medication. 2. Subject satisfied all entry criteria for the antecedent study (SPD503-315 or SPD503-316). 3. Subject who is a female of child-bearing potential (FOCP), defined as >9 years of age or =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has any current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis [except oppositional defiant disorder (ODD)], including any severe comorbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder (PTSD), bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder (OCD), substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis or conduct disorder that, in the opinion of the Investigator, contraindicate treatment with SPD503 or confound efficacy or safety assessments. Review the Kiddie Schedule for Affective Disorders and Schizophrenia – Present and Lifetime version (K-SADS-PL) from the antecedent study to confirm diagnosis, if necessary. 2. Subject who early terminated from Study SPD503-315 or Study SPD503-316 for protocol non-adherence, subject non-compliance, an adverse event (AE), serious adverse event (SAE), or withdrawal by subject. 3. Subject experienced any clinically significant AE in a prior SPD503 study (SPD503- 315 or SPD503-316) that, in the opinion of the Investigator, would preclude exposure to SPD503. 4. Clinically important abnormality on urine drug and/or alcohol screen at the Screening Visit (Visit 1). 5. Subject has taken any investigational medicinal product as follows: last dose of investigational product in Study SPD503-315 within 7 days prior to the Baseline Visit (Visit 2); investigational product in Study SPD503-316 within 30 days prior to the Baseline Visit (Visit 2); any other investigational product within 30 days prior to the Baseline Visit (Visit 2) or any other ADHD medication within 30 days prior to Baseline Visit (Visit 2). 6. Subject is significantly overweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age sex-specific charts at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >95th percentile. 7. Children aged 6 to 12 years with a body weight of less than 25.0kg or adolescents aged 13 years and older with a body weight of less than 34.0kg at the Screening Visit (Visit 1). 8. Subject has any condition or illness including clinically significant abnormal laboratory values at the Screening Visit (Visit 1) which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study. 9. 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. 10. Subject has clinically significant ECG findings, as judged by the Investigator with consideration of the central ECG laboratory’s interpretation, at the Baseline Visit (Visit 2). 11. Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride, or any components found in SPD503. 12. Subject has a history of alcohol or other substance abuse or dependence, as defined by DSM-IV-TR (with the exception of nicotine) within the last 6 months. 13. Subject has a history of a seizure disorder (other than a single childhood febrile seizure occurring before the a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the long term safety and tolerability of SPD503. ;Secondary Objective: The secondary objectives of this study are: To assess the maintenance of efficacy of SPD503 that was achieved in the antecedent studies. To provide access to SPD503 for subjects following their participation in SPD503-315 or SPD503-316 for up to 2 years.;Primary end point(s): The primary endpoints of this study are the long-term safety of SPD503 as follows:. • Occurrence of TEAEs from start of treatment to 3 days after cessation • Specific evaluation of BP and pulse at each applicable post baseline visit. • ECG results at each applicable post baseline visit. • C-SSRS at each applicable post baseline visit. • Effects on growth will be assessed at each applicable post baseline visit .;Timepoint(s) of evaluation of this end point: Up to 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints of the study are listed below: • The change from baseline in ADHD-RS-IV total score and the hyperactivity/impulsivity and inattention subscale scores at each of Visits 3-19. Baseline will be defined in 2 ways; firstly as the Baseline Visit from the antecedent study, and secondly as Visit 2 from this study. • The CGI-S at each of Visits 2-19;Timepoint(s) of evaluation of this end point: Up to 2 years. | — |
Countries
Austria, Belgium, Germany, Ireland, Italy, Netherlands, Poland, Spain, Sweden, Ukraine, United Kingdom
Contacts
Public ContactClinical Programs Leadership
Shire Pharmaceutical Development Ltd
Outcome results
None listed