Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia

Allergan

Status and phase: Terminated; Phase 4

Conditions: Spasmodic Torticollis

Treatments: Biological: botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432341

MedAff-BTX-0615

Details and patient eligibility

About

The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck

Enrollment: 54 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
• Successfully treated previously with botulinum toxin type A

Exclusion criteria

• Breast feeding, pregnant, or could become pregnant
• Surgery or spinal cord stimulation for cervical dystonia
• Previous injections of phenol, alcohol for cervical dystonia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

54 participants in 2 patient groups

BOTOX®

Experimental group

Description:

Botulinum toxin type A (BOTOX®)

Treatment:

Biological: botulinum toxin type A

Biological: botulinum toxin type A

Dysport®

Active Comparator group

Description:

Botulinum toxin type A (Dysport®)

Treatment:

Biological: botulinum toxin type A

Biological: botulinum toxin type A