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Completed

NCT Number: NCT01840462

Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia [CD-NIS-Longterm]

The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients.

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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

Observational

Primary location

Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Suffering from cervical dystonia with rotational torticollis/-caput or laterocollis/-caput as the primary component
  • Naïve to botulinum toxin A or pre-treated with botulinum toxin A on a regular basis for at least 2 years prior to inclusion and last injection with Dysport® and last injection between 3 and 6 months prior to inclusion
  • With the intention to be treated with Dysport®

Exclusion criteria

  • The subject has already been included in this study
  • Participation in an interventional trial
  • Suffering from anterocollis or retrocollis as primary component

Treatment and study plan

Primary outcomes

  1. Change in Tsui scores

    Time frame: Baseline and 12 weeks post-injection Cycle 2

    The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.

Secondary outcomes

  1. Change in Tsui scores

    Time frame: Baseline and 12 weeks post-injection Cycle 1

    The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.

  2. Change in Tsui scores

    Time frame: Baseline and 12 weeks post-injection Cycle 3

    The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.

  3. Change in Tsui scores

    Time frame: Baseline and 12 weeks post-injection Cycle 4

    The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A National, Multicenter, Non-interventional, Prospective, Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia (Dysport®)

Acronym: CDNISLongterm

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Apr 25, 2013
Registry last updated
Jan 14, 2019

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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