The Efficacy and Safety of MEDITOXIN® in Children With Cerebral Palsy

Last updated: March 25, 2019
Sponsor: Medy-Tox
Overall Status: Completed

Phase

4

Condition

Limb Spasticity

Cerebral Palsy

Treatment

N/A

Clinical Study ID

NCT01256021
MT_PRT_CP02
  • Ages 2-18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of children with cerebral palsy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pediatric patients aged between 2 and 18 years with diagnosis of spastic cerebralpalsy

  • Patients with toe-walking due to peroneal muscle spasticity (patients with equinusfoot deformity due to spasticity)

  • Patients who voluntarily consent to participate in this study and whose legallyacceptable representative has signed the informed consent form (if the patient is ableto write, his/her signature should be also obtained).

Exclusion

Exclusion Criteria:

  • Patients who had previously received botulinum toxin within 3 months prior to thestudy entry

  • Patients with known hypersensitivity to botulinum toxin

  • Patients who requires legs, feet or ankle surgery at present

  • Patients with severe athetoid movement

  • Patients who is participating in other investigational study at present

  • Patients, by the investigator's discretion, who are not suitable for this study.

Study Design

Total Participants: 212
Study Start date:
August 01, 2010
Estimated Completion Date:
May 31, 2011

Study Description

The allocated subject is injected Meditoxin® 4U/kg body weight(for patients with hemiplegia) or 6U/kg body weight(for patients with diplegia)in the affected gastrocnemius muscle for the treatment of patients who suffer Equinus Foot Deformity with pediatric cerebral palsy due to spasticity.

The efficacy and safety are evaluated for 12weeks through 3 follow up visits.

Connect with a study center

  • Seoul National University Bundang Hospital

    Seongnam,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National Universtiy Hospital

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Yonsei University Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Sungnam,
    Korea, Republic of

    Site Not Available

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