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COMPLETED Phase 3

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

NCT02604407 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

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

Study Locations (20)

Florida

  • Florida Clinical Research Center Llc — Bradenton
  • Gulfcoast Clinical Research Center — Fort Myers
  • Sarkis Clinical Trials — Gainesville
  • Clinical Neuroscience Solutions, Inc — Jacksonville
  • Florida Clinical Research Center, Llc — Maitland
  • Qps Mra, Llc — Miami
  • Medical Research Group of Central Florida — Orange City
  • Clinical Neuroscience Solutions, Inc — Orlando

California

  • Pharmacology Research Institute — Encino
  • Pharmacology Research Institute (Pri) — Los Alamitos
  • Pharmacology Research Institute (Pri) — Newport Beach
  • Nrc Research Institute — Orange
  • Elite Clinical Trials — Wildomar

Illinois

  • Capstone Clinical — Libertyville
  • Baber Research Group, Inc — Naperville

Colorado

  • McB Clinical Research — Colorado Springs

Georgia

  • Northwest Behavioral Research Center — Marietta

Kansas

  • Psychiatric Associates — Overland Park

Louisiana

  • Louisiana Research Associates, Inc. — New Orleans

Michigan

  • Rochester Center For Behavioral Medicine — Rochester Hills

Trial Details

FieldValue
Enrollment Target 275 participants
Start Date 2015-11-19
Est. Completion 2016-03-24
Phase Phase 3

Sponsor

Shire

56 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02604407

The ClinicalTrials.gov registry entry for NCT02604407 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Attention Deficit Hyperactivity Disorder (ADHD) appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02604407 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02604407 about?

NCT02604407 is a clinical study titled "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.

What is the current status of trial NCT02604407?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 275 participants. The study started on 2015-11-19. Estimated completion is 2016-03-24.

What conditions does trial NCT02604407 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder (ADHD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02604407?

The interventions under investigation include: Placebo (OTHER), SHP465 12.5mg capsules (one capsule daily) (DRUG), SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02604407?

This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02604407 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial