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Completed

NCT Number: NCT00564681

Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia

Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of cervical dystonia

Exclusion criteria

  • Current or previous botulinum toxin treatment of any type for any condition

Treatment and study plan

Botulinum toxin type A

Biological

Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.

Other names: BOTOX®

botulinum toxin type A Formulation 2

Biological

Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.

normal saline

Drug

Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.

Primary outcomes

  1. Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1

    Time frame: Baseline, Week 4

    Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. A negative change from baseline represents improvement and a positive change from baseline indicates worsening.

Secondary outcomes

  1. Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1

    Time frame: Week 4

    Physician's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.

  2. Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1

    Time frame: Week 4

    Patient's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.

  3. Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1

    Time frame: Baseline, Week 4

    Change from baseline in pain as evaluated with the TWSTRS pain subscale at Week 4 of Treatment Cycle 1. The TWSTRS pain subscale scores range from 0 to 20 (0=no pain and 20=worst pain), based on severity of neck pain (0=no pain and 10=worst pain), the duration of pain (0=none and 5=most), and the degree of disability (0=none and 5=most). A negative number change from Baseline represents a decrease in pain (improvement).

  4. Duration of Treatment Effect for Treatment Responders

    Time frame: Up to 6 Months

    Duration of Treatment Effect for Treatment Responders is defined as the number of days from the date of first treatment to the first visit after Week 4 of Treatment Cycle 1, at which the Total TWSTRS score reaches at least 90% of the baseline score. A treatment responder is defined as a patient who has at least a 30% reduction in Total TWSTRS score at Week 4 after the first treatment. The TWSTRS score measures the impact of cervical dystonia on patients (0=least symptoms and 85= worst symptoms).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Nov 28, 2007
Registry last updated
Jan 5, 2016

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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