A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
Overview
- Phase
- Phase 3
- Intervention
- SHP465 12.5mg capsules (one capsule daily)
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Sponsor
- Shire
- Enrollment
- 275
- Locations
- 43
- Primary Endpoint
- Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must be 18-55 years of age
- •Subject is able to provide written, personally signed and dated informed consent.
- •Subject is willing and able to comply with all of the testing and requirements defined in the protocol
- •Subject, who is a female, must not be pregnant.
- •Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities.
- •Subject has a primary diagnosis of ADHD.
- •Subject has an adult ADHD-RS with prompts total score ≥28 at the baseline visit.
- •Subject must have a minimum level of intellectual functioning, as determined by the investigator.
- •Subject is able to swallow a capsule.
- •Subject is currently not on ADHD therapy or is not completely satisfied with any aspect of their current ADHD therapy.
Exclusion Criteria
- •Subject has a current, comorbid psychiatric diagnosis with significant symptoms.
- •Subject is considered a suicide risk in the opinion of the investigator
- •Subject has a body mass index (BMI) of \<18.5 kg/m2 at the screening visit.
- •Subject has a BMI ≥40 kg/m2 at the screening visit.
- •Subject has a concurrent chronic or acute illness, disability, or other condition.
- •Subject has a history of seizure, a chronic or current tic disorder, or a current diagnosis of Tourette's disorder.
- •Subject has a history of moderate to severe hypertension.
- •Subject has a known history of symptomatic cardiovascular disease
- •Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- •Subject has any clinically significant ECG or clinically significant laboratory abnormality at the screening visit.
Arms & Interventions
SHP465 12.5 mg
Subjects will receive SHP465 12.5 mg
Intervention: SHP465 12.5mg capsules (one capsule daily)
SHP465 37.5 mg
Subjects will receive SHP465 titrated up to 37.5 mg
Intervention: SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
Placebo
Subjects will receive matching placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)
Time Frame: 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 and inattentiveness. Adult prompts are included with the ADHD-RS to create a semistructured measurement that allows the clinician to probe the extent, frequency, breadth, severity, and consequences of these symptoms to ascertain impairment in an adult population.
Secondary Outcomes
- Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)(Visit 6 (Week 4))