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

December 4, 2015 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of cervical dystonia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: botulinum toxin Type A
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Biological: botulinum toxin type A
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Other Names:
  • BOTOX®
Active Comparator: botulinum toxin Type A Formulation 2
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Biological: botulinum toxin type A Formulation 2
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Other: Placebo (Normal Saline) / botulinum toxin Type A
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
Biological: botulinum toxin type A
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Other Names:
  • BOTOX®
Drug: Normal Saline
Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.
Other: Placebo (Normal Saline) / botulinum toxin Type A Formulation 2
Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
Biological: botulinum toxin type A Formulation 2
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Drug: Normal Saline
Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)'.
Week 4
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)'.
Week 4
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).
Baseline, Week 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).
Up to 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 26, 2007

First Submitted That Met QC Criteria

November 26, 2007

First Posted (Estimate)

November 28, 2007

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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