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

Torticollis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384214
• Other study ID #: MedAff-BTX-0716
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2011
• Last updated: June 28, 2011
• Start date: October 2008
• Est. completion date: June 2009

Study information

• 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

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Torticollis

Intervention

Biological:
• botulinum toxin Type A
750 U at Visit 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Croatia, 

Outcome

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