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

NCT02604407 | Completed Phase 3 Results

• 1 other identifier: SHP465-306
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 45

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)

  Visit 6 (Week 4)

Study Arms (3)

SHP465 12.5 mg

EXPERIMENTAL

Subjects will receive SHP465 12.5 mg

Drug: SHP465 12.5mg capsules (one capsule daily)

SHP465 37.5 mg

EXPERIMENTAL

Subjects will receive SHP465 titrated up to 37.5 mg

Drug: SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)

Placebo

PLACEBO COMPARATOR

Subjects will receive matching placebo

Other: Placebo

Interventions

SHP465 12.5mg capsules (one capsule daily) DRUG

one capsule daily

SHP465 12.5 mg

Placebo OTHER

Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily)

Placebo

SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily) DRUG

One capsule daily

SHP465 37.5 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (45)

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Pharmacology Research Institute (Pri)

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute (Pri)

Newport Beach, California, 92660, United States

Location

Nrc Research Institute

Orange, California, 92868, United States

Location

Elite Clinical Trials

Wildomar, California, 92595, United States

Location

McB Clinical Research

Colorado Springs, Colorado, 80910, United States

Location

Florida Clinical Research Center Llc

Bradenton, Florida, 32401, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32256, United States

Location

Florida Clinical Research Center, Llc

Maitland, Florida, 32751, United States

Location

Qps Mra, Llc

Miami, Florida, 33143, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Capstone Clinical

Libertyville, Illinois, 60048, United States

Location

Baber Research Group, Inc

Naperville, Illinois, 60563, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

Louisiana Research Associates, Inc.

New Orleans, Louisiana, 70114, United States

Location

Rochester Center For Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Clinical Neurophysiology Services

Sterling Heights, Michigan, 48314, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Premier Psychiatric Research Institutute

Lincoln, Nebraska, 68526, United States

Location

Center For Psychiatry and Behavioral Medicine, Inc

Las Vegas, Nevada, 89128, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Bioscience Research Llc

Mount Kisco, New York, 10549, United States

Location

Nyu Langone Medical Center

New York, New York, 10016, United States

Location

Richard H Weisler, Md, Pa & Associates

Raleigh, North Carolina, 27609, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Ips Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Oregon Center For Clinical Investigations, Inc

Portland, Oregon, 97214, United States

Location

Oregon Center For Clinical Investigations

Salem, Oregon, 97301, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Rainbow Research, Inc.

Barnwell, South Carolina, 29812, United States

Location

Coastal Carolina Research

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

Futuresearch Trials of Dallas, Lp

Dallas, Texas, 75231, United States

Location

Bayou City Research, Ltd

Houston, Texas, 77007, United States

Location

Red Oak Psychiatry Associates

Houston, Texas, 77090, United States

Location

Houston Clinical Trials, Llc

Houston, Texas, 77098, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Neuroscience, Inc

Herndon, Virginia, 20170, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

Summit Research Network (Seattle) Llc

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 28712074 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 13, 2015
• Study Start: November 19, 2015
• Primary Completion: March 24, 2016
• Study Completion: March 24, 2016
• Last Updated: June 3, 2021
• Results First Posted: June 14, 2017

Record last verified: 2021-05

Locations

US (45)