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

Pilot Study of the Effect of Botulinum Toxin Type A Treatment on Swallowing in Patients With Cervical Dystonia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01384214

Enrollment

Registered

2011-06-29

Start date

2008-10-31

Completion date

2009-06-30

Last updated

2011-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Torticollis

Brief summary

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

Interventions

BIOLOGICALbotulinum toxin Type A

750 U at Visit 1

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)	Baseline, Week 2

Secondary

Measure	Time frame
Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score	Week 4
Physician Assessment of Cervical Dystonia Severity	Week 4
Global Assessment of Benefit by Physician	Week 4
Global Assessment of Benefit by Patient	Week 4
Patient Visual Analog Assessment of Pain	Week 4

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026