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A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

NCT00950664 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2017-07-05

Study results available
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Summary

1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.
2. double blind, randomised, multi center, crossover study

Conditions

  • Cervical Dystonia

Interventions

DRUG

Dysport® (abobotulinumtoxinA)

Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

DRUG

Botox® (onabotulinumtoxinA)

Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY

  • Medical Research Collaborating Center, Seoul, Korea

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Beom S Jeon, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-01-31
Completion
2011-07-31

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00950664 on ClinicalTrials.gov