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Clinical Trials/NCT00528541
NCT00528541CompletedPhase 4

Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia

Allergan5 sites in 5 countries145 target enrollmentStarted: September 1, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Allergan
Enrollment
145
Locations
5
Primary Endpoint
Dysphagia Incidence Over 10 Weeks
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
  • •Successfully treated previously with botulinum toxin type A

Exclusion Criteria

  • •Breast feeding, pregnant or could become pregnant
  • •Surgery or spinal cord stimulation for cervical dystonia
  • •Previous injections of phenol, alcohol for cervical dystonia

Outcomes

Primary Outcomes

Dysphagia Incidence Over 10 Weeks

Time Frame: 10 weeks

Dysphagia Incidence (difficulty swallowing) was defined as the number of patients reporting at least 1 treatment-emergent dysphagia event at any point in the study. Occurrences of dysphagia were captured as spontaneous events or were assessed during study visits using the Structured Symptom Interview (SSI) and the Dystonia Study Group Dysphagia Interview (DSGDI) for symptoms of difficulty swallowing; coughing while eating and drinking; choking while eating or drinking; or difficulty swallowing solids or liquids.

Secondary Outcomes

  • Physician Comparison of Benefit to Previous Injections at Week 10(Week 10)
  • Patient Comparison of Benefit to Previous Injections at Week 10(Week 10)
  • Global Assessment of Benefit by Patient at Week 4(Week 4)
  • Global Assessment of Benefit by Physician at Week 4(Week 4)
  • Patient Assessment of Need for Retreatment at Week 4(Baseline, Week 4)
  • Patient Visual Analog Assessment of Pain at Week 4(Baseline, Week 4)
  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4(Baseline, Week 4)
  • Physician Assessment of Cervical Dystonia Severity at Week 4(Baseline, Week 4)

Investigators

Sponsor
Allergan
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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