Neubotulinum Toxin Injection in Cerivical Dystonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-03

Study Completion Date

2021-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia

NCT03805152

Cervical Dystonia

COMPLETED PHASE3

The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients

NCT01664013

Botulinum Toxin Quality of Life Cervical Dystonia

UNKNOWN PHASE4

Assessing Cervical Dystonia

NCT03587350

Dystonia

COMPLETED NA

Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia

NCT02706795

Torticollis (Spasmodic)

COMPLETED PHASE2

Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition and Safety in Patients With Cervical Dystonia

NCT02175693

Cervical Dystonia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Dystonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assignment Double Blind randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

complete Double Blind randomized controlled trial

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

50 unit of Neubotulinum Toxin Type A (Neuronox)

50 unit of Neubotulinum Toxin Type A (Neuronox) injection for Cervical Dystonia in patient diagnosed with cervical dystonia according to clinical diagnosis

Group Type EXPERIMENTAL

Neuronox ® Injection

Intervention Type DRUG

Neuronox ® 50 or 100 unit intramuscular injection

100 unit of Neubotulinum Toxin Type A (Neuronox)

100 unit of Neubotulinum Toxin Type A (Neuronox) injection for Cervical Dystonia in patient diagnosed with cervical dystonia according to clinical diagnosis

Group Type EXPERIMENTAL

Neuronox ® Injection

Intervention Type DRUG

Neuronox ® 50 or 100 unit intramuscular injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neuronox ® Injection

Neuronox ® 50 or 100 unit intramuscular injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neuronox ® 50 unit or 100 unit

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

•The subject has to grant permission to enter into the study by signing and dating the informed consent form before completing any study-related procedure such as any assessment or 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 investigator to avoid pregnancy during the study and to use condom or other contraceptive measure if necessary. The subject was required to have a negative urine pregnancy test before being eligible for the study. (At each of the subsequent visit, a urine pregnancy test was performed).
* Subject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment.
* Subject should undergo a normal physical and neurological examination TWSTRS, CDIP-58, SF36, and CES-D • during the whole study period

Exclusion Criteria

* The subject was pregnant or lactating.
* The subject was a female at risk of pregnancy during the study and not taking adequate precautions against pregnancy.
* The subject had a known hypersensitivity to any of the test materials or related compounds.
* 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. myasthenia gravis, Lambert - Elton Syndrome)

* Subject with significant medical / neurological / psychiatric disorders such as blood dyscrasia, thrombocytopenia, rheumatoid arthritis, congestive heart failure, coronary artery heart diseases, dementia, psychosis, or other conditions which could influence the clinical trial.
* Known history of drug abuse (narcotic (s), cafergot, or others) or drug (botulinum toxin type A) allergy.
* Unable to cooperate fill-up TWSTRS, CDIP-58, SF36, and CES-D • Patient who planned to schedule elective surgery during the study.
* The used of aminoglycoside antibiotics and curare were not allowed during the study.

Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes