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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adult Cerebral Palsy

Intervention / Treatment
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* Drug: Meditoxin
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment-Placebo Group<br>Treatment on 0 day Placebo at 5th week | Drug: Meditoxin<br> <br> |
| Active Comparator: Placebo-Treatment Group<br>Placebo on 0 day Treatment at 5th week | Drug: Normal saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline TWSTRS at 0 week. | 0, 16, 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain in numerical rating scale (NRS) | Pain in numerical rating scale (NRS) | Every 4 weeks, up to 32 weeks | 
| Japanese Orthopaedic Association (JOA) score | Change of Japanese Orthopaedic Association (JOA) score from baseline Japanese Orthopaedic Association (JOA) score at 0 week. | Every 4 weeks, up to 32 weeks | 
| Goal attainment scale | Goal attainment scale of subjective improvement from the baseline status at 0 and 16 weeks. | 4, 12, 20, 28 weeks |