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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Adult Cerebral Palsy

Treatments: Drug: Meditoxin; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01860196

MT_IT_009

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups

Treatment-Placebo Group

Active Comparator group

Description:

Treatment on 0 day Placebo at 5th week

Treatment:

Drug: Meditoxin

Placebo-Treatment Group

Active Comparator group

Description:

Placebo on 0 day Treatment at 5th week

Treatment:

Drug: Normal saline