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Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia

NCT00564681 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2016-01-05

Study results available
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Summary

Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.

Conditions

  • Cervical Dystonia

Interventions

BIOLOGICAL

botulinum toxin type A

Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.

BIOLOGICAL

botulinum toxin type A Formulation 2

Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.

DRUG

Normal Saline

Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

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
2007-12-31
Primary Completion
2008-12-31
Completion
2009-12-31

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Hungary
  • India
  • Philippines
  • Poland
  • Russia
  • Serbia
  • Singapore
  • Slovakia
  • South Africa
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

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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 NCT00564681 on ClinicalTrials.gov