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NCT01753310 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

A Phase 3 study of Cervical Dystonia, sponsored by Ipsen.

Completed
Registry status
Phase 3
Development phase
134
Enrollment target
20
Study locations

NCT01753310 is a Phase 3 study of Cervical Dystonia that has completed, run by Ipsen. The registered enrollment target is 134 participants, above the 78-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (72% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT01753310, a Phase 3 study of Cervical Dystonia, has completed, sponsored by Ipsen.

COMPLETED
Registry status
Phase 3
Development phase
134 participants
Enrollment target
20
Study locations

Study Summary

The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.

Conditions Studied

Interventions

  • DRUG Placebo
  • BIOLOGICAL Botulinum toxin type A

Study Locations (20)

Florida

  • Parkinson's & Movement Disorders Center of Boca Raton - Boca Raton
  • University of Florida Center for Movement Disorders and Neurorestoration - Gainesville
  • Emerald Coast Center for Neurological Disorders - Pensacola
  • PD Treatment Center of SW FL - Port Charlotte
  • University of South Florida - Tampa
  • Guilford Neurologic Associates - West Palm Beach
  • Premiere Research Institute at Palm Beach Neurology - West Palm Beach

California

  • East Bay Physician's Group - Berkeley
  • Parkinson's and Movement Disorder Institute - Fountain Valley
  • Loma Linda University Healthcare, Department of Neurology - Loma Linda
  • USC Keck School of Medicine - Los Angeles
  • UC Davis Medical Center - Sacramento

Arizona

  • Movement Disorders Center of Arizona, LLC - Scottsdale
  • University of Arizona - Tucson

Colorado

  • University of Colorado at Denver Health Sciences - Aurora
  • Advanced Neurosciences Research - Fort Collins

Alabama

  • University of Alabama at Birmingham - Birmingham

Connecticut

  • Associated Neurologists of Southern Connecticut - Fairfield

District of Columbia

  • Georgetown University Hospital - Washington D.C.

Georgia

  • Emory University - Atlanta

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2013-01
Est. Completion 2015-01
Phase Phase 3

Sponsor

Ipsen

85 total trials

What the Registry Record Tells You About NCT01753310

The ClinicalTrials.gov registry entry for NCT01753310 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 78-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (72% higher). The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cervical Dystonia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01753310 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT01753310 about?

NCT01753310 is a clinical study titled "Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.". The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.

What is the current status of trial NCT01753310?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 2013-01. Estimated completion is 2015-01.

What conditions does trial NCT01753310 study?

This clinical trial studies the following conditions: Cervical Dystonia.

What interventions are being tested in trial NCT01753310?

The interventions under investigation include: Placebo (DRUG), Botulinum toxin type A (BIOLOGICAL).

Who is sponsoring clinical trial NCT01753310?

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

Where is trial NCT01753310 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.