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Completed

NCT Number: NCT01753349

Phase IV-Cervical Dystonia-INTEREST IN CD2

The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).

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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

Bab El Oued Hospital, Algiers, Algeria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject for whom there is an intention to treat with BoNT-A.
  • BoNT treatment naïve or previously treated with BoNT.
  • If previously treated with BoNT, at least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion.
  • Subject able to comply with the protocol.
  • Provision of written informed consent prior to collect the data.

Exclusion criteria

  • Contraindications to any BoNT-A preparations.
  • The subject has already been included in the study.

Treatment and study plan

Botulinum toxin type A

Biological

Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.

Primary outcomes

  1. Change in subject's satisfaction using a 5-point Likert scale.

    Time frame: Baseline and at every 3 to 4 months, up to 3 years.

    Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD.

Secondary outcomes

  1. Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale.

    Time frame: Baseline and at every 3 to 4 months, up to 3 years.

    Assessment of severity of CD.

  2. Change in tremor associated with CD using Tsui score

    Time frame: Baseline and at every 3 to 4 months, up to 3 years.

  3. Change in pain relief assessed using the TWSTRS pain sub-scale.

    Time frame: Baseline and at every 3 to 4 months, up to 3 years.

  4. Change in disability will be measured with the TWSTRS disability sub-scale.

    Time frame: Baseline and at every 3 to 4 months, up to 3 years.

  5. Pharmaco-economic endpoints

    Time frame: Baseline and at every 3 to 4 months, up to 3 years.

    • Time intervals between injections
    • Changes in concomitant treatments for CD and associated symptoms.
    • Changes in employment status

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

An International Observational Prospective Study On Long-Term Response To Botulinum Toxin Type A (BoNT-A) Injections In Subjects Suffering From Idiopathic Cervical Dystonia (CD) - Pharmaco-Economic Impact

Acronym: INTEREST_INCD2

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2012
Registry last updated
Nov 5, 2020

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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