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

Adult Cerebral Palsy Clinical Trial

— ATHETOID_CD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860196
• Other study ID #: MT_IT_009
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2013
• Last updated: August 19, 2017
• Start date: June 2013
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Cerebral Palsy
• Cerebral Palsy
• Dystonia
• Paralysis
• Torticollis

Intervention

Drug:
• Meditoxin

• Normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effect	vital sign, adverse effect	Every 4 weeks, up to 32 weeks
Other	computed tomography (CT)	Change of cervical spine computed tomography (CT) from baseline CT at 0 week.	0, 32 weeks
Other	videofluoroscopic swallowing study (VFSS)	Change of videofluoroscopic swallowing study (VFSS) from baseline VFSS at 0 week.	0, 12, 28 weeks
Other	Blood/Urine laboratory tests	Hemoglobin, Hematocrit, RBC, WBC, WBC different cell count, Platelet; Alkaline phosphatase, BUN, Creatinine, SGPT(ALT), SGOT(AST), Albumin, Total protein, Total bilirubin, Uric acid, Glucose, Cholesterol, LDH, Na, Ca, K, Cl; Urine pH, Protein, Glucose, Bilirubin, Blood, WBC	0, 16, 32 weeks
Primary	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	Pain in numerical rating scale (NRS)	Pain in numerical rating scale (NRS)	Every 4 weeks, up to 32 weeks
Secondary	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
Secondary	Goal attainment scale	Goal attainment scale of subjective improvement from the baseline status at 0 and 16 weeks.	4, 12, 20, 28 weeks