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Completed

NCT Number: NCT00950664

A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia. 2. double blind, randomised, multi center, crossover study

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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bundang Seoul Natiuonal University Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

About this study

  • Prospective, randomized, head-to-head, double-blind, cross-over study.
  • Total patients: A group 51, B group 51
  • Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox)
  • Compare the TSUI change score from baseline to 4 weeks after injection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years of age of both genders,
  • Cervical dystonia
  • symptoms with a minimum duration of 18 months,
  • Negative pregnancy test in sexually active women,
  • Able to participate in the study (understand goals of botulinum toxin A treatment and sign Informed Consent Form).

Exclusion criteria

  • Patient with cervical contractures
  • Known significant underlying dysphasia
  • Patients who have received botulinum toxin treatment within the past 4 months.
  • Contraindication to botulinum toxin treatment
  • Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert syndrome, ALS …)
  • Patients who have received oral anti-spasticity medication, phenol therapy, myotomy or denervation surgery, deep brain stimulation for cervical dystonia,
  • Patients who required more than 500 units of Dysport or 200 units of Botox.
  • Any concomitant treatment that could interfere with the action of botulinum toxin,
  • Subjects having participated within the last 3 months or currently participating in an investigational drug study,
  • Pregnancy,
  • Lactation.

Treatment and study plan

Dysport® (abobotulinumtoxinA)

Drug

Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

Other names: Dysport® (abobotulinumtoxinA)injection

Botox® (onabotulinumtoxinA)

Drug

Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

Other names: Botox® (onabotulinumtoxinA)injection

Primary outcomes

  1. Reduction of Total Tsui Score at 4 Weeks From Baseline

    Time frame: 4 weeks after injection from baseline

    Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor.

    Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.

Secondary outcomes

  1. Reduction of Total TWSTRS Score at 4 Weeks From Baseline

    Time frame: 4 weeks after injection from baseline

    TWSTRS (Toronto western spasmodic torticollis rating scale) The TWSTRS is a composite scale which covers different features of cervical dystonia(CD).

    The first part is based on the physical findings (severity subscale), the second part rates disability, and the third part pain.

    (range: 0-80, higher values represent worse cervical dystonia.) Details of the TWSTRS are displayed on the Web site http://www.wemove.org. Negative numbers to represent decreases of TWSTRS.

  2. CGI-I (Clinical Global Impression of Illness)

    Time frame: 4, 8, 12 and 16 weeks after injection

    The proportion of patients with 'normal/ not at all ill' or 'borderline mildly ill' on the CGI (Clinical global impression of illness, CGI-I)

    1 = normal / not at all ill'; 2 = 'borderline mildly ill'; 3 = 'mildly ill'; 4 = 'moderlately ill'; 5 = 'markedly ill'; 6 = 'severely ill'; 7 = 'the most extremely ill'.

  3. PGI-I (Patient's Global Impression of Improvement)

    Time frame: 4, 8, 12 and 16 weeks after injection

    The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I)

    1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated

Other outcomes

  1. Reduction of Tsui Score at Each Visit From Baseline

    Time frame: 8, 12 and 16 weeks after injection

    Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.

  2. Reduction of Total TWSTRS at Each Visit From Baseline

    Time frame: 8, 12 and 16 weeks after injection

    TWSTRS scale (Toronto western spasmodic torticollis rating scale, range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS scale.

  3. Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline

    Time frame: 4, 8, 12 and 16 weeks after injection

    Pain subscale of TWSTRS scale.(Range: 0-20) Negative numbers to represent decreases of TWSTRS pain subscale.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ipsen
  • Medical Research Collaborating Center, Seoul, Korea

Registry information

Official study title

A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® in Comparison With Botox®, Assuming a Bioequivalence Ratio of 2.5:1 Units, in the Cervical Dystonia

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 3, 2009
Registry last updated
Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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