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IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia

NCT00407030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2013-07-19

Study results available
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Summary

At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.

Conditions

  • Cervical Dystonia

Interventions

DRUG

incobotulinumtoxinA (Xeomin) (240 Units)

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units)

DRUG

incobotulinumtoxinA (Xeomin) (120 Units)

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units)

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Cynthia Comella, M.D. · Rush University Medical Center, 1725 West Harrison Street, Suite 755, Chicago, 60612 Illinois, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-01-31
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00407030 on ClinicalTrials.gov