Neubotulinum Toxin Injection in Cerivical Dystonia

NCT04582929 | Completed Phase 3 DMC

• 1 other identifier: A-02-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (2)

• Toronto Western Spasmodic Torticollis Rating scale ( TWSTRS)

  WSTRS ranged( 0-85 by summation of all 3 sub- scales ) higher represent a worse outcome TWSTRS Sub- scale includes TWSTRS-Total severity scale ( maximum 35 points) TWSTS-Disability scale (maximum 30 points) TWSTS-Pain scale (maximum 20 points)

  24 week

• Cervical Dystonia Impact Profile 58 ( CDIP-58)

  Cervical Dystonia Impact Profile-58 items composed of 8 sub-scale Total score by summation of 8 subscale higher represent a worse outcome Analysis both total score (range 58-290 points) And sub-scale analysis composed of Head and neck symptoms ( 6 items ; 6-30 points) Pain and discomfort ( 5 items ; 5-25 points) Upper limb activity ( 9 items ; 9-45 points) Walking ( 9 items ; 9-45 points) Sleep ( 4 items ; 4-20 points) Annoyance ( 8 items ; 8-40 points) Mood (7 items ; 7-35 points) Psychosocial functioning ( 10 items ; 10-50 points)

  24 week

Secondary Outcomes (4)

• Comparesion the quality of life 36 item ( SF 36)

  24 week

• Depression scale measured by Center of Epidemiologic Study of Depression 20 item ( CES-D 20)

  24 week

• Depression scale measured by Patient Health Questionnaire Depression Scale (PHQ-9)

  24 week

• Clinical Global Impression of Changed ( CGIC)

  24 week

Study Arms (2)

50 unit of Neubotulinum Toxin Type A (Neuronox)

EXPERIMENTAL

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

Drug: Neuronox ® Injection

100 unit of Neubotulinum Toxin Type A (Neuronox)

EXPERIMENTAL

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

Drug: Neuronox ® Injection

Interventions

Neuronox ® Injection DRUG

Neuronox ® 50 or 100 unit intramuscular injection

Also known as: Neuronox ® 50 unit or 100 unit

100 unit of Neubotulinum Toxin Type A (Neuronox); 50 unit of Neubotulinum Toxin Type A (Neuronox)

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (4)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Lampang Hospital

Lampang, 52000, Thailand

Location

Suratthani Hospital

Surat Thani, 84000, Thailand

Location

Sappasitthiprasong Hospital

Ubon Ratchathani, 34000, Thailand

Location

Related Publications (2)

• 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.

  PMID: 28138245 RESULT

• 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.

  PMID: 29731634 RESULT

MeSH Terms

Conditions

Torticollis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: complete Double Blind randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Subsai Kongsaengdao

Model Details: Crossover Assignment Double Blind randomized controlled trial

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: January 3, 2019
• Primary Completion: April 30, 2021
• Study Completion: May 30, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (4)