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

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Botulinum Toxins, Type A

Criteria

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