Torticollis Clinical Trial
Official title:
Pilot Study of the Effect of Botulinum Toxin Type A Treatment on Swallowing in Patients With Cervical Dystonia
Verified date | June 2011 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Croatia: Ministry of Health and Social Care |
Study type | Interventional |
The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.
Status | Completed |
Enrollment | 28 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE) | Baseline, Week 2 | No | |
Secondary | Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score | Week 4 | No | |
Secondary | Physician Assessment of Cervical Dystonia Severity | Week 4 | No | |
Secondary | Global Assessment of Benefit by Physician | Week 4 | No | |
Secondary | Global Assessment of Benefit by Patient | Week 4 | No | |
Secondary | Patient Visual Analog Assessment of Pain | Week 4 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01041157 -
Botulinum Toxin Injection Efficiency
|
Phase 1 | |
Completed |
NCT00535938 -
MDs on Botox Utility (MOBILITY)
|
N/A | |
Terminated |
NCT03270189 -
Effect of the Visual Information Change in Functional Dystonia
|
N/A | |
Completed |
NCT00072956 -
The Physiology of Tricks
|
N/A | |
Recruiting |
NCT05917678 -
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
|
N/A | |
Terminated |
NCT00879450 -
Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
|
N/A | |
Completed |
NCT00347334 -
Is Home Positioning Time Associated With Torticollis Rate of Recovery?
|
Phase 1 | |
Recruiting |
NCT05317390 -
Clinical Validation of DystoniaNet Deep Learning Platform for Diagnosis of Isolated Dystonia
|
N/A | |
Completed |
NCT01655862 -
A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA
|
N/A | |
Completed |
NCT01056861 -
Effects of Botulinum Toxin in Cervical Dystonia
|
N/A | |
Withdrawn |
NCT00175604 -
Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis
|
Phase 1 |