Open-label extention study with Guanfacine Hydrochloride in Subjects with Attention-deficit/Hyperactivity Disorder (ADHD)
- Conditions
- Attention deficit/hypercativity disorderMedDRA version: 14.1Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-004668-31-IT
- Lead Sponsor
- SHIRE PHARMACEUTICALS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 249
For subjects enrolling from antecedent Study SPD503-315:
Subjects will be eligible for Study SPD503-318 if they met the response criteria for entry into Phase 2 of Study SPD503-315, were randomised, and either completed Phase 2 or withdrew early because the protocol-defined treatment failure criteria were met.
For subjects enrolling from antecedent Study SPD503-316:
Children aged 6-12 years, upon entry to SPD503-316, regardless of treatment group, must have completed 10 weeks of double-blind treatment in Study SPD503-316, reached Visit 15/Final, and completed the 2 week dose taper.
Adolescents aged 13 years and older, regardless of treatment group, must have completed 13 weeks of double blind treatment in Study SPD503-316, reached Visit 15/Final, and completed the 2-week dose taper.
For all subjects:
1.Subjects where Study SPD503-318 was not available at the time of their final visit in the antecedent study (SPD503-315 or SPD503-316), may still be screened unless they are well-controlled on another ADHD medication with acceptable tolerability and the parent(s)/caregiver(s) is satisfied with their 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 <9 years of age and is post-menarchal, must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at the Baseline Visit (Visit 2) and agree to comply with any applicable contraceptive requirements of the protocol.
4.Subject’s parent(s) or legally authorised representative(s) (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) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
5.Subject and parent(s)/LAR(s) are willing, able, and likely to fully comply with all the testing and requirements defined in this protocol, including oversight of dosing. Specifically, the parent(s)/LAR(s) must be available upon awakening, to dispense the dose of investigational product for the duration of the study.
6.Subject has a supine and standing blood pressure (BP) measurement within the 95th percentile for age, sex, and height.
7.Subject is functioning at an age-appropriate level intellectually, as deemed by the Investigator.
8.Subject is able to swallow intact tablets.
Are the trial subjects under 18? yes
Number of subjects for this age range: 245
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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), including any severe comorbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder, bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder, 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. The Kiddie Schedule for Affective Disorders and Schizophrenia – Present and Lifetime version (K-SADS-PL) rating from the antecedent study should be reviewed 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 AE, SAE, or withdrawal by subject.
3.Subject experienced any clinically significant AE in their 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 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 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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision? (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 se
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to provide access to SPD503 for subjects following their participation in SPD503-315 or SPD503-316, for up to 2 years or where applicable, until the outcome of a Marketing Application, whichever comes first.;Secondary Objective: The secondary objectives of this study are:<br>•To evaluate the long-term safety and tolerability of SPD503<br>•To assess the maintenance of efficacy of SPD503 achieved in antecedent studies.;Primary end point(s): The primary endpoints of this study are the long-term safety of SPD503 as follows: <br>•Occurrence of TEAEs<br>•Specific evaluation of BP and pulse<br>•ECG results<br>•C-SSRS<br>•Effects on growth will be assessed.;Timepoint(s) of evaluation of this end point: Up to 2 anni
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary efficacy endpoints of the study are listed below: <br>•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.<br>•The CGI-S at each of Visits 2 19;Timepoint(s) of evaluation of this end point: Up to 2 years