Phase 3
Completed N=338
Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT01244490 ↗Enrolled (actual)
338
Serious AEs
0.6%
Results posted
Jul 2014
Primary outcomePrimary: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF) — -15.0; -23.9; -18.8 units on a scale — p=<0.001
Summary
For children and adolescents, how does SPD503 compare to placebo for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF) |
-15.0; -23.9; -18.8 | <0.001 sig |
| SECONDARY Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores |
44.1; 67.9; 56.3 | <0.001 sig |
| SECONDARY Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF |
-0.419; -0.636; -0.581 | 0.003 sig |
| SECONDARY Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF |
-0.409; -0.617; -0.499 | 0.006 sig |
| SECONDARY Clinical Global Impression-Severity of Illness (CGI-S) - LOCF |
9.9; 14.3; 6.3; 15.3; 23.2; 19.6 | <0.001 sig |
| SECONDARY Health Utilities Index-2/3 (HUI 2/3) Scores - LOCF |
0.927; 0.922; 0.913 | — |
| SECONDARY Change From Baseline in the WFIRS-P Global Score at Week 10/13 - LOCF |
-0.321; -0.487; -0.425 | 0.001 sig |
| SECONDARY Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 10/13 - LOCF |
-0.555; -0.766; -0.681 | 0.043 sig |
| SECONDARY Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 10/13 - LOCF |
-0.363; -0.592; -0.544 | <0.001 sig |
| SECONDARY Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 10/13 - LOCF |
-0.383; -0.477; -0.450 | 0.096 |
| SECONDARY Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 10/13 - LOCF |
-0.312; -0.361; -0.390 | 0.500 |
| SECONDARY Change From Baseline in the WFIRS-P Social Domain Score at Week 10/13 - LOCF |
-0.322; -0.555; -0.434 | 0.001 sig |
| SECONDARY Change From Baseline in the WFIRS-P Risk Domain Score at Week 10/13 - LOCF |
-0.134; -0.190; -0.173 | 0.139 |
| SECONDARY Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Weeks 10/13 - LOCF |
-5.6; -8.3; -6.5 | — |
| SECONDARY Structure Side-Effect Questionnaire |
19; 30; 39; 11; 7; 25 | — |
| SECONDARY Columbia-Suicide Severity Rating Scale (C-SSRS) |
2; 3; 5; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, aged 6 17 years at the time of consent/assent at Screening (Visit 1).
- 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) Guidance E6, and applicable regulations before completing any study related procedures at Screening (Visit 1).
- Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD, combined sub-type, hyperactive/impulsive sub-type, or inattentive sub-type based on a detailed psychiatric evaluation using the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K-SADS-PL).
- Subject has a minimum ADHD-RS-IV total score of 32 at Baseline (Visit 2).
- Subject has a minimum CGI-S score of 4 at Baseline (Visit 2).
- Subject is functioning at an age-appropriate level intellectually, as judged by the Investigator.
- Subject and parent/LAR understand, are willing, able, and likely to fully comply with the study procedures and restrictions defined in this protocol.
- Subject is able to swallow intact tablets and capsules.
- Subject who is a female of child-bearing potential (FOCP), defined as greater than or equal to 9 years of age or 95th percentile.
- Children aged 6 12 years with a body weight of less than 25kg or adolescents aged 13 17 years with a body weight of less than 34kg or greater than 91kg at Screening (Visit 1).
- Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or atomoxetine hydrochloride, or any components found in SPD503 or STRATTERA.
- Clinically important abnormality on drug and alcohol screen (excluding the subject's current ADHD stimulant if applicable) at Screening (Visit 1)
- Subject is female and is pregnant or currently lactating.
- Subject failed screening or was previously enrolled in this study.
- 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 suicide ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
- History of failure to respond to an adequate trial of an α2-agonist or atomoxetine hydrochloride for the treatment of ADHD (consisting of an appropriate dose and adequate duration of therapy in the opinion of the investigator).
- Subjects with renal or hepatic insufficiency.
Data sourced from ClinicalTrials.gov (NCT01244490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.