Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
NCT ID: NCT02604407
Last Updated: 2021-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
275 participants
INTERVENTIONAL
2015-11-19
2016-03-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SHP465 12.5 mg
Subjects will receive SHP465 12.5 mg
SHP465 12.5mg capsules (one capsule daily)
one capsule daily
SHP465 37.5 mg
Subjects will receive SHP465 titrated up to 37.5 mg
SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
One capsule daily
Placebo
Subjects will receive matching placebo
Placebo
Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily)
Interventions
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SHP465 12.5mg capsules (one capsule daily)
one capsule daily
Placebo
Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily)
SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
One capsule daily
Eligibility Criteria
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Inclusion Criteria
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 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.
18 Years
55 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Pharmacology Research Institute
Encino, California, United States
Pharmacology Research Institute (Pri)
Los Alamitos, California, United States
Pharmacology Research Institute (Pri)
Newport Beach, California, United States
Nrc Research Institute
Orange, California, United States
Elite Clinical Trials
Wildomar, California, United States
McB Clinical Research
Colorado Springs, Colorado, United States
Florida Clinical Research Center Llc
Bradenton, Florida, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States
Florida Clinical Research Center, Llc
Maitland, Florida, United States
Qps Mra, Llc
Miami, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Capstone Clinical
Libertyville, Illinois, United States
Baber Research Group, Inc
Naperville, Illinois, United States
Psychiatric Associates
Overland Park, Kansas, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States
Rochester Center For Behavioral Medicine
Rochester Hills, Michigan, United States
Clinical Neurophysiology Services
Sterling Heights, Michigan, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
Midwest Research Group
Saint Charles, Missouri, United States
Premier Psychiatric Research Institutute
Lincoln, Nebraska, United States
Center For Psychiatry and Behavioral Medicine, Inc
Las Vegas, Nevada, United States
Princeton Medical Institute
Princeton, New Jersey, United States
Bioscience Research Llc
Mount Kisco, New York, United States
Nyu Langone Medical Center
New York, New York, United States
Richard H Weisler, Md, Pa & Associates
Raleigh, North Carolina, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Ips Research Company
Oklahoma City, Oklahoma, United States
Oregon Center For Clinical Investigations, Inc
Portland, Oregon, United States
Oregon Center For Clinical Investigations
Salem, Oregon, United States
Omega Medical Research
Warwick, Rhode Island, United States
Rainbow Research, Inc.
Barnwell, South Carolina, United States
Coastal Carolina Research
Mt. Pleasant, South Carolina, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, United States
Futuresearch Trials of Dallas, Lp
Dallas, Texas, United States
Bayou City Research, Ltd
Houston, Texas, United States
Red Oak Psychiatry Associates
Houston, Texas, United States
Houston Clinical Trials, Llc
Houston, Texas, United States
Research Across America
Plano, Texas, United States
Neuroscience, Inc
Herndon, Virginia, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Summit Research Network (Seattle) Llc
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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SHP465-306
Identifier Type: -
Identifier Source: org_study_id
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