Status:

COMPLETED

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

Lead Sponsor:

Seoul National University Hospital

Conditions:

Adult Cerebral Palsy

Eligibility:

All Genders

20+ years

Phase:

PHASE4

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, Clini...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2017

Estimated Enrollment :

17 Patients enrolled

Trial Details

Trial ID

NCT01860196

Start Date

June 1 2013

End Date

June 1 2017

Last Update

August 22 2017

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