A Phase 4 study to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged release (SPD503) in Children and Adolescents aged 6 to 17 Years with ADHD
- Conditions
- Attention-deficit/hyperactivity disorder (ADHD)MedDRA version: 23.0Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- EUCTR2018-000821-29-BE
- Lead Sponsor
- Takeda Development Center Americas, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 288
PART A
1. Subject is a male or female aged 6 to 17 years inclusive at the time of consent/assent.
2. Subject must meet DSM-5 criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation using the Kiddie-Schedule for Affective Disorders-Present and Lifetime Version (K-SADSPL) at screening (Visit 1A).
3. Subject for whom prior stimulant therapy is not suitable, not tolerated, or shown to be ineffective as determined by investigator clinical assessment and review of the Prior Stimulant Medication Questionnaire (PSMQ) administered during screening (Visit 1A).
4. Subject has an ADHD-RS-5 total score =28 at baseline (Visit 2A).
5. Subject has a baseline (Visit 2A) CGI-S score =4.
6. Subject who is a female of childbearing potential (FOCP) and postmenarchal must have a negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy test at screening (Visit 1A) and a negative urine pregnancy test at baseline (Visit 2A), be nonlactating, and agree to comply with any applicable contraceptive requirements described in the protocol. Female of childbearing potential is defined as any female subject who is at least aged 9 years or younger than 9 years and postmenarchal.
7. Subject’s parent or legally authorized representative (LAR) must provide signature of informed consent. Documentation of assent (if applicable) must be provided 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 Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
8. 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 for the duration of the study to administer the IMP dose each morning when the subject awakens.
9. Subject has supine and standing blood pressure (BP) measurements within the 95th percentile for age, sex, and height at both screening (Visit 1A) and baseline (Visit 2A).
10. Subject is functioning at an age-appropriate level intellectually, as judged by the investigator.
11. Subject is able to swallow intact tablets.
PART B
1.Female subjects of child-bearing potential must have a negative serum ß-hCG pregnancy test at baseline and agree to comply with any applicable contraceptive requirements of the protocol. An FOCP is defined as any female subject who is at least aged 9 years or younger than 9 years and postmenarchal.
2.Subject has a supine and standing BP measurement within the 95th percentile for age, sex, and height.
Are the trial subjects under 18? yes
Number of subjects for this age range: 288
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
PART A
1. Subject has a current, controlled (requiring medication or therapy) or uncontrolled, comorbid psychiatric disorder (except oppositional defiant disorder), including but not limited to any of the following comorbid Axis I and Axis II disorders (the K-SADS-PL should be reviewed to confirm diagnosis, if necessary):
a. Post-traumatic stress disorder (PTSD)
b. Bipolar illness, psychosis, or family history in either biological parent
c. Pervasive developmental disorder
d. Obsessive-compulsive disorder (OCD)
e. Psychosis/schizophrenia
f. Serious tic disorder or a family history of Tourette’s disorder
2. Subject is currently considered to be a suicide risk by the investigator; has made a previous suicide attempt; has a history of, or currently demonstrating, active suicidal ideation.
3. Subject has a substance abuse disorder as defined by DSM-5 criteria or has been suspected of a substance abuse or dependence disorder (except nicotine) within the past 6 months.
4. Subject has a clinically important abnormality on the urine drug and alcohol screen (except for the subject’s current ADHD stimulant, if applicable) at screening (Visit 1A).
5. Subject has been physically, sexually, and/or emotionally abused.
6. Subject has any other disorder that as judged by the investigator could contraindicate TAK-503 or confound the results of the safety and efficacy assessments.
7. Subject has any condition or illness including any clinically significant abnormal laboratory value at screening (Visit 1A) or, if the laboratory test was repeated, at baseline (Visit 2A) that, as judged by the investigator, would be an inappropriate risk to the subject and/or could confound the interpretation of study results.
8. Subject has current abnormal thyroid function, defined as abnormal thyroid-stimulating hormone and thyroxine at screening (Visit 1A). Treatment with a stable dose of thyroid medication for =3 months before screening will be permitted.
9. Subject has a known history or presence of: malignancy (except nonmelanoma skin cancer), pregnancy, and/or a developmental delay or abnormality associated with growth or sexual maturation delays that are not related to ADHD.
10. Children aged 6 to 12 years with a body weight <25.0 kg or adolescents aged =13 years with a body weight <34.0 kg at screening (Visit 1A) or baseline (Visit 2A).
11. Subject is significantly overweight based on the Centers for Disease Control (CDC) BMI-for-age sex-specific charts at screening (Visit 1A) or baseline (Visit 2A). For this study, significantly overweight will be defined as a BMI that is greater than the 95th percentile.
12. Subject has a known history or presence of: structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (eg, clinically significant heart block or QT interval prolongation), bradycardia, or exercise-related cardiac events including syncope and presyncope.
13. Subject has clinically significant ECG findings, as judged by the investigator, at baseline (Visit 2A).
14. Subject has orthostatic hypotension or a known history of hypertension.
15. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
16. Subject is currently using any medication that violates protocol-specified washout criteria at baseline (Visit 2A), including any ADHD medication or other prohibited medications such as herbal supplements, medications that affect BP or heart rate (HR) or medications that have central n
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method