Back to resultsStudy to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
Primary Purpose
Cervical Dystonia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
botulinum toxin type A
botulinum toxin type A Formulation 2
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dystonia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of cervical dystonia
Exclusion Criteria:
- Current or previous botulinum toxin treatment of any type for any condition
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Other
Other
Arm Label
botulinum toxin Type A
botulinum toxin Type A Formulation 2
Placebo (Normal Saline) / botulinum toxin Type A
Placebo (Normal Saline) / botulinum toxin Type A Formulation 2
Arm Description
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
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.
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.
Outcomes
Primary Outcome Measures
Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1
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 Outcome Measures
Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1
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)'.
Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1
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)'.
Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1
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).
Duration of Treatment Effect for Treatment Responders
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00564681
Brief Title
Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin Type A
Arm Type
Active Comparator
Arm Description
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Arm Title
botulinum toxin Type A Formulation 2
Arm Type
Active Comparator
Arm Description
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Arm Title
Placebo (Normal Saline) / botulinum toxin Type A
Arm Type
Other
Arm Description
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.
Arm Title
Placebo (Normal Saline) / botulinum toxin Type A Formulation 2
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
botulinum toxin type A
Other Intervention Name(s)
BOTOX®
Intervention Description
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Intervention Type
Biological
Intervention Name(s)
botulinum toxin type A Formulation 2
Intervention Description
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.
Primary Outcome Measure Information:
Title
Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1
Description
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.
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1
Description
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)'.
Time Frame
Week 4
Title
Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1
Description
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)'.
Time Frame
Week 4
Title
Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1
Description
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).
Time Frame
Baseline, Week 4
Title
Duration of Treatment Effect for Treatment Responders
Description
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).
Time Frame
Up to 6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cervical dystonia
Exclusion Criteria:
Current or previous botulinum toxin treatment of any type for any condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
Prague
Country
Czech Republic
City
Berlin
Country
Germany
City
Budapest
Country
Hungary
City
Mumbai
Country
India
City
Manila
Country
Philippines
City
Warsaw
Country
Poland
City
Moscow
Country
Russian Federation
City
Belgrade
Country
Serbia
City
Singapore
Country
Singapore
City
Spisska Nova
Country
Slovakia
City
Cape Town
Country
South Africa
City
Tainan
Country
Taiwan
City
Bangkok
Country
Thailand
City
Bristol
Country
United Kingdom
12. IPD Sharing Statement
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Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
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