Effect of Botulinum Toxin Type A on Swallowing in Patients With Cervical Dystonia

Allergan28 enrolled

Overview

The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Torticollis

Interventions

botulinum toxin Type ABIOLOGICAL

750 U at Visit 1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with cervical dystonia * Successfully completed Allergan study MedAff BTX-0616 with 16 weeks since last botulinum toxin Type A injection * In need of additional botulinum toxin Type A injections Exclusion Criteria: * Surgery or spinal cord stimulation for cervical dystonia * Previous injections of phenol or alcohol for cervical dystonia

Locations (1)

Unnamed facility

Zagreb, Croatia

Outcomes

Primary Outcomes

Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)

Time frame: Baseline, Week 2

Secondary Outcomes

Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score

Time frame: Week 4

Physician Assessment of Cervical Dystonia Severity

Time frame: Week 4

Global Assessment of Benefit by Physician

Time frame: Week 4

Global Assessment of Benefit by Patient

Time frame: Week 4

Patient Visual Analog Assessment of Pain

Time frame: Week 4

Data from ClinicalTrials.gov

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