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

Allergan

Status and phase: Completed; Phase 4

Conditions: Torticollis

Treatments: Biological: botulinum toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01384214

MedAff-BTX-0716

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

1

Experimental group

Description:

botulinum toxin Type A

Treatment:

Biological: botulinum toxin Type A