An extension study to enable patients to continue to receive Guanfacine Hydrocloride Extended Release tablets after completing either study SPD503-315 or SPD503-316.
- Conditions
- Attention Deficit/Hyperactivity Disorder (ADHD)MedDRA version: 17.0Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 100000004873Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-004668-31-GB
- Lead Sponsor
- Shire Pharmaceutical Development 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 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 <9 years of age and is post-menarchal, must have a negative serum beta
Human Chorionic Gonadotropin (ß-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 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) Good Clinical Practice (GCP)
Guideline E6 and applicable regulations, before completing any study-related
procedures.
5. Subject and parent/LAR 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/LAR 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: 249
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
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
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 evaluate the long term safety and tolerability of SPD503. ;Secondary Objective: The secondary objectives of this study are:<br>To assess the maintenance of efficacy of SPD503 that was achieved in the antecedent studies.<br>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:.<br>• Occurrence of TEAEs from start of treatment to 3 days after cessation<br>• Specific evaluation of BP and pulse at each applicable post baseline visit. <br>• ECG results at each applicable post baseline visit.<br>• C-SSRS at each applicable post baseline visit. <br>• 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 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.