Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)

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)

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Drug: SHP465 12.5mg capsules (one capsule daily); Drug: SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute (PRI)
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute (PRI)
    • Orange, California, United States, 92868
      • NRC Research Institute
    • Wildomar, California, United States, 92595
      • Elite Clinical Trials
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • McB Clinical Research
  • Florida
    • Bradenton, Florida, United States, 32401
      • Florida Clinical Research Center LLC
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research Center
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center, LLC
    • Miami, Florida, United States, 33143
      • Qps Mra, Llc
    • Orange City, Florida, United States, 32763
      • Medical Research Group of Central Florida
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Behavioral Research Center
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical
    • Naperville, Illinois, United States, 60563
      • Baber Research Group, Inc
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Psychiatric Associates
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Louisiana Research Associates, Inc.
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • Rochester Center for Behavioral Medicine
    • Sterling Heights, Michigan, United States, 48314
      • Clinical Neurophysiology Services
  • Missouri
    • O'Fallon, Missouri, United States, 63368
      • Psychiatric Care and Research Center
    • Saint Charles, Missouri, United States, 63304
      • Midwest Research GRoup
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Premier Psychiatric Research Institutute
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center For Psychiatry And Behavioral Medicine, Inc
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Princeton Medical Institute
  • New York
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research LLC
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Richard H Weisler, Md, Pa & Associates
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
  • Oregon
    • Portland, Oregon, United States, 97214
      • Oregon Center for Clinical Investigations, Inc
    • Salem, Oregon, United States, 97301
      • Oregon Center for Clinical Investigations
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Barnwell, South Carolina, United States, 29812
      • Rainbow Research, Inc.
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions
  • Texas
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LP
    • Houston, Texas, United States, 77007
      • Bayou City Research, Ltd
    • Houston, Texas, United States, 77090
      • Red Oak Psychiatry Associates
    • Houston, Texas, United States, 77098
      • Houston Clinical Trials, LLC
    • Plano, Texas, United States, 75093
      • Research Across America
  • Virginia
    • Herndon, Virginia, United States, 20170
      • Neuroscience, Inc
  • Washington
    • Kirkland, Washington, United States, 98033
      • Eastside Therapeutic Resource
    • Seattle, Washington, United States, 98104
      • Summit Research Network (Seattle) Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Subject has current abnormal thyroid function

Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.

Subject has failed to respond, to an adequate course(s) of amphetamine therapy.

Subject has a history of suspected substance abuse or dependence disorder.

Subject has a positive urine drug result at the screening visit (with the exception of subject's current stimulant therapy, if any) or Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the screening visit.

Subject has previously completed, has discontinued, or was withdrawn from this study.

Subject is taking any medication that is excluded or has not been appropriately washed out according to the protocol requirements.

Subject is required to take or anticipates the need to take medications that have CNS effects or affect performance.

Subject is female and is pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SHP465 12.5 mg; Subjects will receive SHP465 12.5 mg	Drug: SHP465 12.5mg capsules (one capsule daily); one capsule daily
EXPERIMENTAL: SHP465 37.5 mg; Subjects will receive SHP465 titrated up to 37.5 mg	Drug: SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily); One capsule daily
PLACEBO_COMPARATOR: Placebo; Subjects will receive matching placebo	Other: Placebo; Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at 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.	Baseline, Visit 6 (Week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression of Improvement (CGI-I) Score at 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).	Visit 6 (Week 4)

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General Publications

• Weisler RH, Greenbaum M, Arnold V, Yu M, Yan B, Jaffee M, Robertson B. Efficacy and Safety of SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults: Results of a Randomized, Double-Blind, Placebo-Controlled, Forced-Dose Clinical Study. CNS Drugs. 2017 Aug;31(8):685-697. doi: 10.1007/s40263-017-0455-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 19, 2015
• Primary Completion (ACTUAL): March 24, 2016
• Study Completion (ACTUAL): March 24, 2016

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (ESTIMATE): November 13, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: SHP465-306