Clinical trial NCT02604407: Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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.

Primary outcomes:
measure: Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)
timeFrame: Baseline, Visit 6 (Week 4)
Secondary outcomes:
measure: Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)
timeFrame: Visit 6 (Week 4)
Other outcomes:
Locations:
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute (Pri)
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute (Pri)
state: California
city: Orange
country: United States
facility: Nrc Research Institute
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials
state: California
city: Colorado Springs
country: United States
facility: McB Clinical Research
state: Colorado
city: Bradenton
country: United States
facility: Florida Clinical Research Center Llc
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, Llc
state: Florida
city: Miami
country: United States
facility: Qps Mra, Llc
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical
state: Illinois
city: Naperville
country: United States
facility: Baber Research Group, Inc
state: Illinois
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc.
state: Louisiana
city: Rochester Hills
country: United States
facility: Rochester Center For Behavioral Medicine
state: Michigan
city: Sterling Heights
country: United States
facility: Clinical Neurophysiology Services
state: Michigan
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center
state: Missouri
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institutute
state: Nebraska
city: Las Vegas
country: United States
facility: Center For Psychiatry and Behavioral Medicine, Inc
state: Nevada
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: Mount Kisco
country: United States
facility: Bioscience Research Llc
state: New York
city: New York
country: United States
facility: Nyu Langone Medical Center
state: New York
city: Raleigh
country: United States
facility: Richard H Weisler, Md, Pa & Associates
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Ips Research Company
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center For Clinical Investigations, Inc
state: Oregon
city: Salem
country: United States
facility: Oregon Center For Clinical Investigations
state: Oregon
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Barnwell
country: United States
facility: Rainbow Research, Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions
state: Tennessee
city: Dallas
country: United States
facility: Futuresearch Trials of Dallas, Lp
state: Texas
city: Houston
country: United States
facility: Bayou City Research, Ltd
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates
state: Texas
city: Houston
country: United States
facility: Houston Clinical Trials, Llc
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: Herndon
country: United States
facility: Neuroscience, Inc
state: Virginia
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) Llc
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.