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NCT02163915 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder.

A Phase 1 study, sponsored by Takeda.

Terminated
Registry status
Phase 1
Development phase
47
Enrollment target

NCT02163915: Clinical Trial Phase 1 study, sponsored by Takeda.

NCT02163915 is a Phase 1 study that was terminated before completion, run by Takeda. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02163915, a Phase 1 study, was terminated before completion, sponsored by Takeda.

TERMINATED
Registry status
Phase 1
Development phase
47 participants
Enrollment target

Study Summary

The purpose of this study is to characterize the safety and tolerability of TAK-137 when administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder (ADHD).

Primary Outcome

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is def

Interventions

  • DRUG TAK-137
  • DRUG TAK-137 Placebo

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2014-06
Est. Completion 2014-11
Phase Phase 1
Takeda

408 total trials

Why NCT02163915 stopped before completion

NCT02163915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).

The record links to 0 conditions, and to 2 interventions - of which TAK-137 is the first listed.

NCT02163915 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02163915 about?

NCT02163915 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder.". The purpose of this study is to characterize the safety and tolerability of TAK-137 when administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder (ADHD).

What is the current status of trial NCT02163915?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2014-06. Estimated completion is 2014-11.

What interventions are being tested in trial NCT02163915?

The interventions under investigation include: TAK-137 (DRUG), TAK-137 Placebo (DRUG).

Who is sponsoring clinical trial NCT02163915?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02163915's enrollment target sits among peer trials

47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02163915, the US trial registry maintained by the National Library of Medicine. NCT02163915 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.