Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy

A Placebo Controlled, Cross-over, Double Blind, Randomized, Clinical Trial to Compare the Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy

This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double blind, Randomized, Clinical trial.

Inclusion Criteria:

• Adult cerebral palsy patients over 20 years old
• Clinically diagnosed for cervical dystonia more than a year ago
• No improvement with antispasmodics for the last month
• Actively participated and gave informed consent

Exclusion Criteria:

• Allergic to the botulinum toxin
• Limited range of motion in cervical spine
• Patients with fever, infection, cancer, uncontrollable seizure
• Generalized neuromuscular junction disease patients
• Pregnant or breast feeding women, or anticipating pregnancy until 12 weeks after the study stopped
• Patients enrolled in other studies
• History of dose change in 4 weeks: antispasmodics, benzodiazepine, anticholinergics
• Botulinum toxin injection history in 6 months
• Previous history of intrathecal baclofen, selective peripheral denervation, deep brain stimulation
• Otherwise clinically non-eligible patients