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

NCT01753310 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2019-08-07

Study results available
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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

  • Cervical Dystonia

Interventions

BIOLOGICAL

Botulinum toxin type A

Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only

DRUG

Placebo

Up to 2mL

Sponsors & Collaborators

Principal Investigators

  • Medical Director, Neurology, M.D. · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-10-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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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 NCT01753310 on ClinicalTrials.gov