Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
1 other identifier
interventional
242
16 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2007
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2007
CompletedFirst Posted
Study publicly available on registry
November 28, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
December 11, 2012
CompletedJanuary 5, 2016
December 1, 2015
1 year
November 26, 2007
November 14, 2012
December 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Week 4
Secondary Outcomes (4)
Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1
Week 4
Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1
Week 4
Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1
Baseline, Week 4
Duration of Treatment Effect for Treatment Responders
Up to 6 Months
Study Arms (4)
botulinum toxin Type A
ACTIVE COMPARATORIntramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
botulinum toxin Type A Formulation 2
ACTIVE COMPARATORIntramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Placebo (Normal Saline) / botulinum toxin Type A
OTHERIntramuscular 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.
Placebo (Normal Saline) / botulinum toxin Type A Formulation 2
OTHERIntramuscular 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.
Interventions
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 placebo (normal saline) into the affected muscles for treatment cycle 1.
Eligibility Criteria
You may qualify if:
- Diagnosis of cervical dystonia
You may not qualify if:
- Current or previous botulinum toxin treatment of any type for any condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (16)
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
Prague, Czechia
Unknown Facility
Berlin, Germany
Unknown Facility
Budapest, Hungary
Unknown Facility
Mumbai, India
Unknown Facility
Manila, Philippines
Unknown Facility
Warsaw, Poland
Unknown Facility
Moscow, Russia
Unknown Facility
Belgrade, Serbia
Unknown Facility
Singapore, Singapore
Unknown Facility
Spisska Nova, Slovakia
Unknown Facility
Cape Town, South Africa
Unknown Facility
Tainan, Taiwan
Unknown Facility
Bangkok, Thailand
Unknown Facility
Bristol, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2007
First Posted
November 28, 2007
Study Start
December 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2009
Last Updated
January 5, 2016
Results First Posted
December 11, 2012
Record last verified: 2015-12