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

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604407
• Other study ID #: SHP465-306
• Status: Completed
• Phase: Phase 3
• Start date: November 19, 2015
• Est. completion date: March 24, 2016

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: March 24, 2016
• Est. primary completion date: March 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Drug:
• SHP465 12.5mg capsules (one capsule daily)
one capsule daily

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

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

Locations

Country	Name	City	State
United States	Rainbow Research, Inc.	Barnwell	South Carolina
United States	Florida Clinical Research Center Llc	Bradenton	Florida
United States	McB Clinical Research	Colorado Springs	Colorado
United States	Futuresearch Trials of Dallas, Lp	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Pharmacology Research Institute	Encino	California
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Neuroscience, Inc	Herndon	Virginia
United States	Bayou City Research, Ltd	Houston	Texas
United States	Houston Clinical Trials, Llc	Houston	Texas
United States	Red Oak Psychiatry Associates	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc	Jacksonville	Florida
United States	Eastside Therapeutic Resource	Kirkland	Washington
United States	Center For Psychiatry and Behavioral Medicine, Inc	Las Vegas	Nevada
United States	Capstone Clinical	Libertyville	Illinois
United States	Premier Psychiatric Research Institutute	Lincoln	Nebraska
United States	Pharmacology Research Institute (Pri)	Los Alamitos	California
United States	Florida Clinical Research Center, Llc	Maitland	Florida
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	Clinical Neuroscience Solutions	Memphis	Tennessee
United States	Qps Mra, Llc	Miami	Florida
United States	Bioscience Research Llc	Mount Kisco	New York
United States	Coastal Carolina Research	Mount Pleasant	South Carolina
United States	Baber Research Group, Inc	Naperville	Illinois
United States	Louisiana Research Associates, Inc.	New Orleans	Louisiana
United States	Nyu Langone Medical Center	New York	New York
United States	Pharmacology Research Institute (Pri)	Newport Beach	California
United States	Psychiatric Care and Research Center	O'Fallon	Missouri
United States	Ips Research Company	Oklahoma City	Oklahoma
United States	Nrc Research Institute	Orange	California
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Research Across America	Plano	Texas
United States	Oregon Center For Clinical Investigations, Inc	Portland	Oregon
United States	Princeton Medical Institute	Princeton	New Jersey
United States	Richard H Weisler, Md, Pa & Associates	Raleigh	North Carolina
United States	Rochester Center For Behavioral Medicine	Rochester Hills	Michigan
United States	Midwest Research Group	Saint Charles	Missouri
United States	Oregon Center For Clinical Investigations	Salem	Oregon
United States	Summit Research Network (Seattle) Llc	Seattle	Washington
United States	Clinical Neurophysiology Services	Sterling Heights	Michigan
United States	Omega Medical Research	Warwick	Rhode Island
United States	Elite Clinical Trials	Wildomar	California

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)