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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01860196

Acronym

ATHETOID_CD

Enrollment

Registered

2013-05-22

Start date

2013-06-30

Completion date

2017-06-30

Last updated

2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Cerebral Palsy

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.

Interventions

DRUGMeditoxin

DRUGNormal saline

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Adverse effect	Every 4 weeks, up to 32 weeks	vital sign, adverse effect
computed tomography (CT)	0, 32 weeks	Change of cervical spine computed tomography (CT) from baseline CT at 0 week.
videofluoroscopic swallowing study (VFSS)	0, 12, 28 weeks	Change of videofluoroscopic swallowing study (VFSS) from baseline VFSS at 0 week.
Blood/Urine laboratory tests	0, 16, 32 weeks	1. Hemoglobin, Hematocrit, RBC, WBC, WBC different cell count, Platelet 2. Alkaline phosphatase, BUN, Creatinine, SGPT(ALT), SGOT(AST), Albumin, Total protein, Total bilirubin, Uric acid, Glucose, Cholesterol, LDH, Na, Ca, K, Cl 3. Urine pH, Protein, Glucose, Bilirubin, Blood, WBC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026