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NCT04403399 · ClinicalTrials.gov registry record · Phase 2

Crossover Target Engagement Study of Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease (Project #3 - Experiment 3 [UdallP3E3])

A Phase 2 study, sponsored by University of Michigan.

Completed
Registry status
Phase 2
Development phase
34
Enrollment target

NCT04403399: Completed Phase 2 study, sponsored by University of Michigan.

NCT04403399 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04403399, a Phase 2 study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study Summary

With an appropriate oral dose of Varenicline (VCN) identified from experiments 1 \& 2 of the study (see NCT02933372), the investigators will administer VCN to Parkinson Disease (PD) participants to determine if VCN improves walking speed and measures of balance. PD participants will receive VCN or a placebo (fake drug) for 3 weeks to assess the effects of VCN administration on gait speed and balance. Participants will undergo examinations to assess the intensity of their Parkinsonism and asked questions to assess their mood and thinking.

Primary Outcome

Gait speed, how fast a person can walk down a corridor, at normal pace with no distractors (i.e., no dual task).

Interventions

  • DRUG Placebo
  • DRUG Varenicline

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2017-06-29
Est. Completion 2019-06-26
Phase Phase 2
University of Michigan

1,327 total trials

What the finished NCT04403399 record still lists

NCT04403399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

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

NCT04403399 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04403399 about?

NCT04403399 is a clinical study titled "Crossover Target Engagement Study of Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease (Project #3 - Experiment 3 [UdallP3E3])". With an appropriate oral dose of Varenicline (VCN) identified from experiments 1 \& 2 of the study (see NCT02933372), the investigators will administer VCN to Parkinson Disease (PD) participants to determine if VCN improves walking speed and measures of balance. PD participants will receive VCN or a...

What is the current status of trial NCT04403399?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2017-06-29. Estimated completion is 2019-06-26.

What interventions are being tested in trial NCT04403399?

The interventions under investigation include: Placebo (DRUG), Varenicline (DRUG).

Who is sponsoring clinical trial NCT04403399?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04403399's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 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 NCT04403399, the US trial registry maintained by the National Library of Medicine. NCT04403399 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.