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

Phase 4

Completed

• Conditions: Adult Cerebral Palsy
• Interventions: Drug: Normal saline; Drug: Meditoxin

• Registration Number: NCT01860196
• Lead Sponsor: Seoul National University Hospital

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, Clinical trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-19
• Study First Posted: 2013-05-22
• Study Start: 2013-06
• Primary Completion: 2017-03
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-19
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo-Treatment Group	Normal saline	Placebo on 0 day Treatment at 5th week
Treatment-Placebo Group	Meditoxin	Treatment on 0 day Placebo at 5th week

Primary Outcome Measures

Name	Time	Method
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)	0, 16, 32 weeks	Change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline TWSTRS at 0 week.

Secondary Outcome Measures

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