Neubotulinum Toxin Injection in Cerivical Dystonia

Last updated: September 16, 2021
Sponsor: Rajavithi Hospital
Overall Status: Completed

Phase

3

Condition

Dystonia

Dyskinesias

Dystonias

Treatment

N/A

Clinical Study ID

NCT04582929
A-02-2020
  • Ages 20-100
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

24-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of 50 unit of Neubotulinum Toxin Type A (Neuronox) and 100 unit of Neubotulinum Toxin Type A (Neuronox) injection for Cervical Dystonia in patient diagnosed with cervical dystonia according to clinical diagnosis. It was designed to evaluate the efficacy, safety, tolerability, quality of life and the comparesion the improvement after treatment by of 50 unit of Neubotulinum Toxin Type A (Neuronox) and 100 unit of Neubotulinum Toxin Type A (Neuronox) injection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

•The subject has to grant permission to enter into the study by signing and dating theinformed consent form before completing any study-related procedure such as any assessmentor evaluation not related to the normal medical care of the subject. Able to give written inform consent and retained one copy of the consent form

  • Male or female subject, aged between 18 - 100 years old.
  • Subject diagnosed to be cervical dystonia.
  • Female subject in good health and sexually active was instructed by the investigatorto avoid pregnancy during the study and to use condom or other contraceptive measureif necessary. The subject was required to have a negative urine pregnancy test beforebeing eligible for the study. (At each of the subsequent visit, a urine pregnancy testwas performed).
  • Subject judged to be reliable for compliance for taking medication and capable ofrecording the effects of the medication and motivated in receiving benefits from thetreatment.
  • Subject should undergo a normal physical and neurological examination TWSTRS, CDIP-58,SF36, and CES-D • during the whole study period

Exclusion

Exclusion Criteria:

  • The subject was pregnant or lactating.
  • The subject was a female at risk of pregnancy during the study and not taking adequateprecautions against pregnancy.
  • The subject had a known hypersensitivity to any of the test materials or relatedcompounds.
  • The subject was unable or unwilling to comply fully with the protocol.
  • The subject received any unlicensed drug within the previous 6 months.
  • Treatment with investigational drug (s) within 6 months before the screening visit. •The subject had previously entered in this study. Subject with past history of botulism, other neuromuscular disorder (e.g. myastheniagravis, Lambert - Elton Syndrome)
  • Subject with significant medical / neurological / psychiatric disorders such as blooddyscrasia, thrombocytopenia, rheumatoid arthritis, congestive heart failure, coronaryartery heart diseases, dementia, psychosis, or other conditions which could influencethe clinical trial.
  • Known history of drug abuse (narcotic (s), cafergot, or others) or drug (botulinumtoxin type A) allergy.
  • Unable to cooperate fill-up TWSTRS, CDIP-58, SF36, and CES-D • Patient who planned toschedule elective surgery during the study.
  • The used of aminoglycoside antibiotics and curare were not allowed during the study.

Study Design

Total Participants: 50
Study Start date:
January 03, 2019
Estimated Completion Date:
May 30, 2021

Study Description

Three documented studies showed the clinical use of botulinum toxin for migraine prophylaxis.(26) Neubotulinum Toxin Type A, (Neu-BoNT/A), (Neuronox® ) (Medytox Inc, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea), also known as Meditoxin in Korea, is a newly manufactured BoNT-A (Neu-BoNT/A) that was developed to provide features close to onabotulinum toxin A (5). Neuronox was tested in a murine model, and its effect on muscle force generation was equivalent to Botox® (ona-BoNT/A) (6). A previous multicenter randomized controlled trial showed that Neuronox and Botox® have equivalent efficacy and safety for the treatment of spastic equinus in children with cerebral palsy (6). However, 50 unit of Neubotulinum Toxin Type A (Neuronox) and 100 unit of Neubotulinum Toxin Type A (Neuronox) has not yet been investigated in cervical dystonia. This study is the extension of the NCT03805152

Connect with a study center

  • Rajavithi Hospital

    Bangkok, 10400
    Thailand

    Site Not Available

  • Lampang Hospital

    Lampang, 52000
    Thailand

    Site Not Available

  • Suratthani Hospital

    Surat Thani, 84000
    Thailand

    Site Not Available

  • Sappasitthiprasong Hospital

    Ubon Ratchathani, 34000
    Thailand

    Site Not Available

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