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

Seoul National University Hospital17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Adult Cerebral Palsy

Interventions

MeditoxinDRUG

Normal salineDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

Change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline TWSTRS at 0 week.

Time frame: 0, 16, 32 weeks

Secondary Outcomes

Pain in numerical rating scale (NRS)

Time frame: 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.

Time frame: 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.

Time frame: 4, 12, 20, 28 weeks

Data from ClinicalTrials.gov

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