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Completed

NCT Number: NCT00257660

Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinic "Cecil Plus", Moscow, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
  • TWSTRS severity, disability and total scores meeting the defined criteria at baseline

Exclusion criteria

  • Pure anterocollis or pure retrocollis
  • In apparent remission from cervical dystonia
  • Previous poor response to the last two botulinum toxin type A or type B treatments
  • Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin

Treatment and study plan

Botulinum toxin type A

Biological

500 units

Other names: AbobotulinumtoxinA (Dysport®)

Placebo

Drug

500 units

Primary outcomes

  1. Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

    Time frame: Baseline and Week 4

    TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.

Secondary outcomes

  1. Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

    Time frame: Baseline and Week 8

    TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.

  2. Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score

    Time frame: Baseline and Week 12

    TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.

  3. Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment

    Time frame: Baseline and Week 4

    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).

  4. Investigator VAS for CD Symptom Assessment

    Time frame: Baseline and Week 4

    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).

  5. Subject VAS for CD Symptom Assessment

    Time frame: Baseline and Week 8

    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).

  6. Investigator's VAS for CD Symptom Assessment

    Time frame: Baseline and week 8

    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).

  7. Subject VAS for CD Symptom Assessment

    Time frame: Baseline and week 12

    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).

  8. Investigator's VAS for CD Symptom Assessment

    Time frame: Baseline and week 12

    The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).

  9. SF-36 Mental Health Summary Score

    Time frame: Week 8

    SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).

  10. SF-36 Physical Health Summary Score

    Time frame: Week 8

    SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).

  11. Number of Participants Considered by the Investigator to be Overall Treatment Successes

    Time frame: Week 12

    The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 23, 2005
Registry last updated
Sep 28, 2022

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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