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NCT04936542 · ClinicalTrials.gov registry record · Phase 4

A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.

A Phase 4 study, sponsored by Ipsen.

Completed
Registry status
Phase 4
Development phase
464
Enrollment target

NCT04936542 is a Phase 4 study that has completed, run by Ipsen. The registered enrollment target is 464 participants.

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The verdict

NCT04936542, a Phase 4 study, has completed, sponsored by Ipsen.

COMPLETED
Registry status
Phase 4
Development phase
464 participants
Enrollment target

Study Summary

This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.

Interventions

  • BIOLOGICAL AboBoNT-A
  • BIOLOGICAL OnaBoNT-A

Trial Details

FieldValue
Enrollment Target 464 participants
Start Date 2021-06-23
Est. Completion 2025-08-26
Phase Phase 4

Sponsor

Ipsen

85 total trials

What the Registry Record Tells You About NCT04936542

The ClinicalTrials.gov registry entry for NCT04936542 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 464 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.

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

NCT04936542 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04936542 about?

NCT04936542 is a clinical study titled "A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.". This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at opt...

What is the current status of trial NCT04936542?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 464 participants. The study started on 2021-06-23. Estimated completion is 2025-08-26.

What interventions are being tested in trial NCT04936542?

The interventions under investigation include: AboBoNT-A (BIOLOGICAL), OnaBoNT-A (BIOLOGICAL).

Who is sponsoring clinical trial NCT04936542?

This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.