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NCT01464307 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke

A Phase 3 study, sponsored by Merz Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
290
Enrollment target

NCT01464307 is a Phase 3 study that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 290 participants.

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The verdict

NCT01464307, a Phase 3 study, has completed, sponsored by Merz Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
290 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

Interventions

  • DRUG Placebo Comparator
  • DRUG IncobotulinumtoxinA (400 Units)

Trial Details

FieldValue
Enrollment Target 290 participants
Start Date 2011-12
Est. Completion 2015-05
Phase Phase 3

Sponsor

Merz Pharmaceuticals

17 total trials

What the Registry Record Tells You About NCT01464307

The ClinicalTrials.gov registry entry for NCT01464307 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 290 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merz Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.

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

NCT01464307 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01464307 about?

NCT01464307 is a clinical study titled "Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke". The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

What is the current status of trial NCT01464307?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 290 participants. The study started on 2011-12. Estimated completion is 2015-05.

What interventions are being tested in trial NCT01464307?

The interventions under investigation include: Placebo Comparator (DRUG), IncobotulinumtoxinA (400 Units) (DRUG).

Who is sponsoring clinical trial NCT01464307?

This trial is sponsored by Merz Pharmaceuticals, which has 17 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.