Status:
COMPLETED
Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy
Lead Sponsor:
Seoul National University Hospital
Conditions:
Adult Cerebral Palsy
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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, Clini...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01860196
Start Date
June 1 2013
End Date
June 1 2017
Last Update
August 22 2017
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