Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia

NCT03805152 | Completed Phase 3 DMC

• 1 other identifier: A-01-2019
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

Brief Summary

A 48-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of, 250 unit of Abobotulinum Toxin Type A (Dysport) and 50 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 Abobotulinum Toxin Type A (Dysport) injection versus Neubotulinum Toxin Type A (Neuronox)Injection.

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (2)

• Toronto Western Spasmodic Torticollis Rating scale ( TWSTRS)

  TWSTRS ranged( 0-85 by summation of all 3 sub- scales ) higher represent a worse outcome TWSTRS Sub- scale includes 1. TWSTRS-Total severity scale ( maximum 35 points) 2. TWSTS-Disability scale (maximum 30 points) 3. 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 the scale compose of -3 to 3 higher represent a good outcome

Study Arms (2)

Neuronox(R) intramuscular injection

ACTIVE COMPARATOR

Neu-botulinum Toxin Type A (Neuronox(R) - botulinum toxin type A product by medyceles company , Korea) 50 units Intramuscular injection in the affected neck muscle that cause cervical dystonia every 12 weeks for 24 weeks ( 2 times , 12 week interval)

Drug: Neuronox(R)

Dysport (R) intramuscular injection

ACTIVE COMPARATOR

Abo-botulinum Toxin Type A (Dysport (R) - botulinum toxin type A product by IPEN company, France ) 250 unit Intramuscular Injection in the affected neck muscle that cause cervical dystonia every 12 weeks for 24 weeks (2 times , 12 week interval)

Drug: Dysport (R)

Interventions

Neuronox(R) DRUG

Injection botulinum toxin intramuscular for affected neck muscle

Also known as: Intramuscular injection

Neuronox(R) intramuscular injection

Dysport (R) DRUG

Intramuscular injection

Dysport (R) intramuscular injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects need to satisfy the following criteria before being allowed to participate in the study:
• 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 WERE NOT ALLOWED TO enter/continue into the study, 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)

Assistant Professor Subsai Kongsaengdao

Bangkok, 10400, Thailand

Location

Lampang Hospital

Lampang, Thailand

Location

Surat Thani hospital

Surat Thani, 84000, Thailand

Location

Sappasithiprasong Hospital

Ubon Ratchathani, 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Torticollis

Interventions

Injections, Intramuscular; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Subsai Kongsaengdao

  Division of Neurology, Department of Medicine, Rajavithi Hospital, Department of Medical services, Public Health Ministry, Bangkok, 10400 Thailand 3 Department of Medicine, College of Medicine, Rangsit University, Bangkok, 10400 Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Complete blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: Double Blind randomized controlled trial

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 15, 2019
• Study Start: October 25, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (4)