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Cervical DystoniaPhase 3NTCDNCT04582929

Neubotulinum Toxin Injection in Cerivical Dystonia

A Phase 3 study testing Neuronox ® Injection in people with Cervical Dystonia, run by Department of Medical Services Ministry of Public Health of Thailand at 4 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Cervical Dystonia
What is being tested?
Neuronox ® Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesThailand
Study dates
3 Jan 2019to 30 May 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • •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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

Thailand4 sites

  • Rajavithi Hospital

    Bangkok, 10400

  • Lampang Hospital

    Lampang, 52000

  • Suratthani Hospital

    Surat Thani, 84000

  • Sappasitthiprasong Hospital

    Ubon Ratchathani, 34000

Other trials in Thailand

About this study

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

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.

Read the 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

Being tested
Neuronox ® Injection
Medical subject headings
Torticollis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuronox ® InjectionDrug

    Also called Neuronox ® 50 unit or 100 unit

    Neuronox ® 50 or 100 unit intramuscular injection

Study groups in NCT04582929
Study groupRoleWhat they receive
50 unit of Neubotulinum Toxin Type A (Neuronox)Experimental50 unit of Neubotulinum Toxin Type A (Neuronox) injection for Cervical Dystonia in patient diagnosed with cervical dystonia according to clinical diagnosis
Receives: Drug: Neuronox ® Injection
100 unit of Neubotulinum Toxin Type A (Neuronox)Experimental100 unit of Neubotulinum Toxin Type A (Neuronox) injection for Cervical Dystonia in patient diagnosed with cervical dystonia according to clinical diagnosis
Receives: Drug: Neuronox ® Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 24 week

  2. 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)

    Measured: 24 week

Secondary outcomes (4)

  1. Comparesion the quality of life 36 item ( SF 36)

    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

    Measured: 24 week

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

    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

    Measured: 24 week

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

    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 (range PHQ 9 0-27 ) higher represent a worse outcome

    Measured: 24 week

  4. Clinical Global Impression of Changed ( CGIC)

    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) (range -3 to 3 points: -3,-2,-1,0,1,2,3)

    Measured: 24 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2020
  2. Study start3 Jan 2019
  3. Primary completion30 Apr 2021
  4. Study completion30 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Crossover Assignment Double Blind randomized controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04582929
Sponsor's protocol ID
A-02-2020
Acronym
NTCD
Status last verified
Sep 2021
First submitted
5 Oct 2020
Last updated
17 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28138245

  • 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.

    PubMed 29731634

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neuronox ® Injection in people with Cervical Dystonia, run by Department of Medical Services Ministry of Public Health of Thailand at 4 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toronto Western Spasmodic Torticollis Rating scale ( TWSTRS) (time frame: 24 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04582929, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.

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