Phase 3
Completed N=89
Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years
Source: ClinicalTrials.gov NCT03325881 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Week 4 — -9.7; -11.6 Score on a scale — p=0.451
◆ Published Evidence
Not yet cited
0citations
A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder.
Summary
The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.
Linked Publications
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A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Week 4 |
-9.7; -11.6 | 0.451 |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) at Week 4 |
3.3; 3.2 | 0.597 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
7; 11 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE) |
1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Clinical Laboratory Test Results Assessed by the Investigator |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Assessed by the Investigator |
0; 0 | — |
| SECONDARY Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Baseline and Week 4 |
20; 14; 23; 28; 13; 11 | — |
| SECONDARY Change From Baseline in Length of Time Awake Per Night and Length of Time to Fall Asleep Per Night Assessed by PSQ at Week 4 |
27.0; 27.2; 19.3; 21.0; 12.4; 8.0 | — |
| SECONDARY Change From Baseline in Length of Time Sleeping Per Night Assessed by PSQ at Week 4 |
8.9; 8.8; 9.1; 8.9 | — |
| SECONDARY Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Week 4 |
42.7; 42.8 | — |
| SECONDARY Number of Participants With a Positive Response in Columbia-suicide Severity Rating Scale (C-SSRS) at Week 4 |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participant is male or female aged 6-12 years inclusive at the time of consent.
- Participant's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent (as applicable) by the participant.
- Participant must meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (any subtype).
- Participant who is a female and of child-bearing potential must not be pregnant and agree to comply with any applicable contraceptive requirements.
- Participant has an ADHD-RS-5 Child, Home Version Total Score of greater than or equal to (>=) 28 and Clinical Global Impression - Severity of Illness (CGI-S) score >=4 at baseline (Visit 2). Participant is currently not on ADHD therapy, or is not completely satisfied with their current ADHD therapy.
Exclusion Criteria
- Participant is required or anticipated to take medications that have central nervous system effects or affect performance. Stable use of bronchodilator inhalers is not exclusionary.
- Participant has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the participant.
- Participant has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
- Participant has failed to fully respond, based on investigator judgment, to an adequate course of amphetamine therapy.
- Participant has a known family history of sudden cardiac death or ventricular arrhythmia.
- Participant has a blood pressure measurement >=95th percentile for age, sex, and height at screening (Visit 1) and/or baseline (Visit 2).
- Participant has a height less than or equal to (<=) 5th percentile for age and sex at screening (Visit 1) or baseline (Visit 2).
- Participant has a weight <=5th percentile for age and sex at screening (Visit 1) or baseline (Visit 2).
- Participant has a known history of symptomatic cardiovascular disease, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac conditions placing them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- Participant has a history of seizures (other than infantile febrile seizures).
- Participant is taking any medication that is excluded per the protocol.
- Participant had any clinically significant ECG or clinical laboratory abnormalities at the screening (Visit 1) or baseline visit (Visit 2).
- Participant has current abnormal thyroid function, defined as abnormal thyroid-stimulating hormone and thyroxine at the screening or baseline visit. Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
- Participant has a current, controlled (requiring medication or therapy) or uncontrolled, comorbid psychiatric disorder.
- Participant 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 currently demonstrating suicidal ideation.
Data sourced from ClinicalTrials.gov (NCT03325881) and the linked publication. 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.