The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
116
500 units
500 units
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
TWSTRS is comprised of three different components which are severity, disability \& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time frame: Baseline and Week 4
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
TWSTRS is comprised of three different components which are severity, disability \& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time frame: Baseline and Week 8
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
TWSTRS is comprised of three different components which are severity, disability \& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time frame: Baseline and Week 12
Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment
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Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States
USC School of Medicine
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Wayne State University Medical Center
Southfield, Michigan, United States
...and 12 more locations
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time frame: Baseline and Week 4
Investigator VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time frame: Baseline and Week 4
Subject VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).
Time frame: Baseline and Week 8
Investigator's VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time frame: Baseline and week 8
Subject VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time frame: Baseline and week 12
Investigator's VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
Time frame: Baseline and week 12
SF-36 Mental Health Summary Score
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).
Time frame: Week 8
SF-36 Physical Health Summary Score
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).
Time frame: Week 8
Number of Participants Considered by the Investigator to be Overall Treatment Successes
The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.
Time frame: Week 12