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

Allergan0 sites145 target enrollmentSeptember 2007

ConditionsSpasmodic Torticollis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Spasmodic Torticollis
Sponsor: Allergan
Enrollment: 145
Primary Endpoint: Dysphagia Incidence Over 10 Weeks
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

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

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

September 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

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)