Adults 18 to 55, any sex, with Attention Deficit Hyperactivity Disorder (ADHD). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)Primary· Baseline, Visit 6 (Week 4)
The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more severe symptoms.The scale is subdivided into 2 subscales of 9 symptoms each: hyperactivity/impulsivity
Baseline
Group
Value
95% CI
Placebo
40.5
± 6.52
SHP465 12.5 mg
39.8
± 6.38
SHP465 37.5 mg
39.9
± 7.07
Change at Visit 6
Group
Value
95% CI
Placebo
-11.0
± 11.47
SHP465 12.5 mg
-18.1
± 13.42
SHP465 37.5 mg
-23.8
± 11.89
Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)Secondary· Visit 6 (Week 4)
CGI scales permit a global evaluation of the participant's severity and improvement over time. CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Group
Value
95% CI
Placebo
3.1
± 1.05
SHP465 12.5 mg
2.4
± 1.16
SHP465 37.5 mg
1.9
± 1.10
Adverse events — posted to ClinicalTrials.gov
Time frame: From the Start of Study Drug Administration up to Follow-up (Week 5).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 3 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02604407.