EUCTR2011-004668-31-GB进行中（未招募）1 期
A Phase 3, Open-label, Multicentre, Protocol to Provide Access to Guanfacine Hydrochloride Extended Release for European Subjects with Attention-deficit/Hyperactivity Disorder (ADHD) who Participated in Study SPD503-315 or SPD503-316
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 249
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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