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Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia (DNCD)

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ClinicalTrials.gov Identifier: NCT03805152
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Subsai Kongsaengdao, Rajavithi Hospital

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.

Condition or disease Intervention/treatment Phase
Cervical Dystonia Drug: Neuronox(R) Drug: Dysport (R) Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double Blind randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Complete blinded
Primary Purpose: Treatment
Official Title: A 48-Week Prospective, Double-Blinded, Randomized, Cross-over Design in Multicenter Study of 250 Unit of Dysport Versus 50 Unit of Neuronox Injection For Cervical Dystonia in Thai Patients
Estimated Study Start Date : April 23, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : August 31, 2020


Arm Intervention/treatment
Active Comparator: Neuronox(R) intramuscular injection
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)
Injection botulinum toxin intramuscular for affected neck muscle
Other Name: Intramuscular injection

Active Comparator: Dysport (R) intramuscular injection
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)
Intramuscular injection




Primary Outcome Measures :
  1. Toronto Western Spasmodic Torticollis Rating scale ( TWSTRS) [ Time Frame: 24 week ]

    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)

  2. Cervical Dystonia Impact Profile 58 ( CDIP-58) [ Time Frame: 24 week ]
    ) 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)


Secondary Outcome Measures :
  1. Comparesion the quality of life 36 item ( SF 36) [ Time Frame: 24 week ]
    Comparesion the quality of life (SF 36) pre- and post- 12 and 24 week ttreatment with 50 unit of Neubotulinum Toxin Type A (Neuronox) and 250 unit of Abobotulinum Toxin Type A (Dysport) this score has special formula calculation

  2. Depression scale measured by Center of Epidemiologic Study of Depression 20 item ( CES-D 20) [ Time Frame: 24 week ]
    Comparesion of CES-D pre- and post- 12 and 24 week treatment with 50 unit of Neubotulinum Toxin Type A (Neuronox) and 250 unit of Abobotulinum Toxin Type A (Dysport) Score ranged from 20-80 points higher represent a worse outcome

  3. Depression scale measured by Patient Health Questionnaire Depression Scale (PHQ-9) [ Time Frame: 24 week ]

    Comparesion of PHQ-9 pre- and post- 12 and 24 week treatment with 50 unit of Neubotulinum Toxin Type A (Neuronox) and 250 unit of Abobotulinum Toxin Type A (Dysport) There is the special scale calculation for diagnosis Major depressive disorder, Other depressive disorder and others,higher points /score represent a worse outcome ranged 0-27 points plus 3 points Total summation of 5-9 points indicate Minimal symptoms, 10-14 Minor depression ++ or Dysthymia* or Major depression, mild , 15-19 points Major depression, moderately severe

    ≥ 20 Major depression, severe


  4. Clinical Global Impression of Changed ( CGIC) [ Time Frame: 24 week the scale compose of -3 to 3 higher represent a good outcome ]
    Comparesion of CGIC pre- and post- 12 and 24 week treatment with 50 unit of Neubotulinum Toxin Type A (Neuronox) and 250 unit of Abobotulinum Toxin Type A (Dysport)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805152


Contacts
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Contact: Subsai Kongsaengdao, M.D. 66818180890 skhongsa@gmail.com

Sponsors and Collaborators
Rajavithi Hospital

Publications:
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Responsible Party: Dr Subsai Kongsaengdao, Associated Professor, Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT03805152     History of Changes
Other Study ID Numbers: A-01-2019
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
abobotulinumtoxinA
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents