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Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia

NCT01261611 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2022-09-28

Study results available
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Summary

The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.

Conditions

  • Cervical Dystonia

Interventions

BIOLOGICAL

Botulinum toxin type A

I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.

BIOLOGICAL

Botulinum toxin type A

I.M. injection on day 1 of treatment cycle 1.

DRUG

Placebo

I.M. injection on day 1 of treatment cycle 1.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-05-31
Completion
2013-06-30

Countries

  • Australia
  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Poland
  • Portugal
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT01261611 on ClinicalTrials.gov