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NCT01124708 · ClinicalTrials.gov registry record · Phase 2

Efficacy, Safety, and Tolerability of TC-5619 in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)

A Phase 2 study, sponsored by Targacept.

Completed
Registry status
Phase 2
Development phase
134
Enrollment target

NCT01124708: Completed Phase 2 study, sponsored by Targacept.

NCT01124708 is a Phase 2 study that has completed, run by Targacept. The registered enrollment target is 134 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01124708, a Phase 2 study, has completed, sponsored by Targacept.

COMPLETED
Registry status
Phase 2
Development phase
134 participants
Enrollment target

Study Summary

ADHD has been associated with persistent deficits in the efficient allocation of attention and supports the notion that regulation of the cholinergic system may improve these cognitive deficits in ADHD. It has been suggested that the effects of nicotine are most pronounced on tasks that demand effortful processing (Rusted and Warburton 1994). In addition, a recent theory proposes that the cholinergic system allocates additional attentional resources during tasks that are demanding (i.e. sustained attention, set shifting, etc; Sarter and Bruno 1997). Thus it may be that in ADHD, cholinergic systems are under-responsive or under-developed and thus stimulation of nicotinic receptors via nicotinic agents may result in improved cognitive performance particularly on tests requiring effortful processing.

Primary Outcome

•Clinician-administered ADHD-rating scale (CAARS-INV) and is the total of 3 subscales: Inattention, Hyperactivity-Impulsivity, and ADHD Index \[ Time Frame: Week -3, Day 1, Week 1, Week 4 (evaluation of 1mg dose); Week 8 (evaluation of 5mg Dose); and Week 12 (evaluation of 25mg dose)\]

Interventions

  • DRUG Placebo
  • DRUG TC-5619-238

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2010-05
Est. Completion 2011-02
Phase Phase 2
Targacept

13 total trials

What the finished NCT01124708 record still lists

NCT01124708 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

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

NCT01124708 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01124708 about?

NCT01124708 is a clinical study titled "Efficacy, Safety, and Tolerability of TC-5619 in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)". ADHD has been associated with persistent deficits in the efficient allocation of attention and supports the notion that regulation of the cholinergic system may improve these cognitive deficits in ADHD. It has been suggested that the effects of nicotine are most pronounced on tasks that demand effor...

What is the current status of trial NCT01124708?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2010-05. Estimated completion is 2011-02.

What interventions are being tested in trial NCT01124708?

The interventions under investigation include: Placebo (DRUG), TC-5619-238 (DRUG).

Who is sponsoring clinical trial NCT01124708?

This trial is sponsored by Targacept, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01124708's enrollment target sits among peer trials

134 537th of 2000 higher than 1,463 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01124708, the US trial registry maintained by the National Library of Medicine. NCT01124708 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.