Phase 3
Completed N=528
Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT01081145 ↗Enrolled (actual)
528
Serious AEs
1.3%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase — 64.9; 49.3 percentage of treatment failures — p=0.006
Summary
The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase |
64.9; 49.3 | 0.006 sig |
| SECONDARY Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase |
56.0; 218.0 | 0.003 sig |
| SECONDARY Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - Last Observation Carried Forward (LOCF) |
15.89; 9.64 | <0.001 sig |
| SECONDARY Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF |
32.5; 50.0 | 0.001 sig |
| SECONDARY Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - LOCF |
0.23; 0.16 | 0.118 |
| SECONDARY Health Utilities Index-2/3 (HUI 2/3) Scores During the Double-Blind Randomized-Withdrawal Phase - LOCF |
0.899; 0.900 | — |
| SECONDARY Columbia-Suicide Severity Rating Scale During Double-Blind Randomized-Withdrawal Phase |
2; 2; 0; 0 | — |
| SECONDARY Change From Open-Label Baseline in ADHD-RS-IV Total Score at Week 13 of the Open-Label Phase - LOCF |
-25.2 | <0.001 sig |
| SECONDARY Percentage of Responders in the Open-Label Phase - LOCF |
68.6 | — |
| SECONDARY Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores During Open-Label Phase - LOCF |
76.1 | — |
| SECONDARY Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on CGI-S Scale During the Open-Label Phase - LOCF |
68.9 | — |
| SECONDARY Change From Open-Label Baseline in WFIRS-P Global Score at Week 13 of the Open-Label Phase - LOCF |
-0.35 | <0.001 sig |
| SECONDARY HUI 2/3 Scores During the Open-Label Phase - LOCF |
0.892 | — |
| SECONDARY Columbia-Suicide Severity Rating Scale During Open-Label Phase |
1; 2 | — |
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) Guideline E6 (1996) and applicable regulations before completing any study-related procedures at Screening/Visit 1.
- Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD, combined subtype, hyperactive/impulsive subtype, 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 Enrolment/Visit 2.
- Subject has a minimum CGI-S score of 4 at Enrolment/Visit 2.
- Subject is functioning at an age-appropriate level intellectually, as deemed by the Investigator.
- Subject and parent/LAR understand, are willing, able, and likely to fully comply with the study requirements, procedures, and restrictions defined in this protocol.
- Subject is able to swallow intact tablets.
- Subject who is a female of child-bearing potential (FOCP), defined as 9 years of age or 95th percentile.
- Children aged 6-12 years with a body weight of 91kg at Screening/Visit 1.
- Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or any components found in SPD503.
- Clinically important abnormality on drug and alcohol screen (excluding the subject's current ADHD stimulant if applicable) at Screening/Visit 1.
- 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.
- 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 suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator (see protocol Section 7.2.4.2 for additional guidance).
- History of failure to respond to an adequate trial of an alpha 2-agonist for the treatment of ADHD (consisting of an appropriate dose and adequate duration of therapy in the opinion of the Investigator).
- Subject has a history of a seizure disorder (other than a single childhood febrile seizure occurring before the age of 3 years) or the presence of a serious tic disorder (including Tourette's syndrome).
- Subject has another member of the same household currently participating in this study.
Data sourced from ClinicalTrials.gov (NCT01081145). 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.