Clinical trial NCT04582929: Neubotulinum Toxin Injection in Cerivical Dystonia
Official title: 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 Thai Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Dystonia
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2020-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment Double Blind randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Toronto Western Spasmodic Torticollis Rating scale ( TWSTRS)
timeFrame: 24 week
measure: Cervical Dystonia Impact Profile 58 ( CDIP-58)
timeFrame: 24 week
Secondary outcomes:
measure: Comparesion the quality of life 36 item ( SF 36)
timeFrame: 24 week
measure: Depression scale measured by Center of Epidemiologic Study of Depression 20 item ( CES-D 20)
timeFrame: 24 week
measure: Depression scale measured by Patient Health Questionnaire Depression Scale (PHQ-9)
timeFrame: 24 week
measure: Clinical Global Impression of Changed ( CGIC)
timeFrame: 24 week
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Lampang
country: Thailand
facility: Lampang Hospital
city: Surat Thani
country: Thailand
facility: Suratthani Hospital
city: Ubon Ratchathani
country: Thailand
facility: Sappasitthiprasong Hospital
Study officials:
References:
citation: Kongsaengdao S, Maneeton B, Maneeton N. Quality of life in cervical dystonia after treatment with botulinum toxin A: a 24-week prospective study. Neuropsychiatr Dis Treat. 2017 Jan 10;13:127-132. doi: 10.2147/NDT.S116325. eCollection 2017.
citation: Kongsaengdao S, Maneeton N, Maneeton B. Long-term quality of life in cervical dystonia after treatment with abobotulinum toxin A: a 2-year prospective study. Neuropsychiatr Dis Treat. 2018 Apr 26;14:1119-1124. doi: 10.2147/NDT.S152252. eCollection 2018.