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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01261611
Registration number
NCT01261611
Ethics application status
Date submitted
15/12/2010
Date registered
16/12/2010
Titles & IDs
Public title
Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia
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Scientific title
A Phase III, Randomised, Double-blind and Open Label Phase, Active and Placebo Controlled Study Comparing the Short-term Efficacy of Two Formulations of Clostridium Botulinum Type A Toxin (Dysport and Dysport NG) to Placebo, and Assessing the Short and Long Term Efficacy and Safety of Dysport NG Following Repeated Treatments of Subjects With Cervical Dystonia
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Secondary ID [1]
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2010-019907-43
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Secondary ID [2]
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Y-52-52120-134
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cervical Dystonia
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Botulinum toxin type A
Treatment: Other - Botulinum toxin type A
Treatment: Drugs - Placebo
Experimental: Dysport NG - 500U (1mL) administered as intramuscular injection on day 1 of treatment cycle 1 and 2.
250U (0.5mL), 500U (1mL) or 750U (1.5mL) administered as intramuscular injection on day 1 of treatment cycle 3.
250U (0.5mL), 500U (1mL), 750U (1.5mL) or 1000U (2mL) administered as intramuscular injection on day 1 of treatment cycle 4 and 5.
Active comparator: Dysport - 500U (1mL) injected as intramuscular injection on day 1 of treatment cycle 1.
Placebo comparator: Placebo - 1mL administered as, intramuscular injection on day 1 of treatment cycle 1.
Treatment: Other: Botulinum toxin type A
I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.
Treatment: Other: Botulinum toxin type A
I.M. injection on day 1 of treatment cycle 1.
Treatment: Drugs: Placebo
I.M. injection on day 1 of treatment cycle 1.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle
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Assessment method [1]
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TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.
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Timepoint [1]
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Baseline and Week 4
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Secondary outcome [1]
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Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Following First Treatment Cycle
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Assessment method [1]
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TWSTRS measures the degree of CD and comprises three different components, one of which is the Severity subscale. TWSTRS Severity subscale scores range from 0 (absence of severity) to 35 (maximum severity). If the change from baseline is negative, this represents an improvement in symptoms.
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Timepoint [1]
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Baseline and Week 4
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Secondary outcome [2]
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Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale Score Following First Treatment Cycle
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Assessment method [2]
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TWSTRS measures the degree of CD and comprises three different components, one of which is the Disability subscale. TWSTRS Disability subscale scores range from 0 (no disability) to 30 (maximum disability). If the change from baseline is negative, this represents an improvement in symptoms.
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Timepoint [2]
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Baseline and Week 4
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Secondary outcome [3]
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Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score Following First Treatment Cycle
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Assessment method [3]
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TWSTRS measures the degree of CD and comprises three different components, one of which is the Pain subscale. TWSTRS Pain subscale scores range from 0 (no pain) to 20 (maximum pain). If the change from baseline is negative, this represents an improvement in symptoms.
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Timepoint [3]
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Baseline and Week 4
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Secondary outcome [4]
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Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia Following First Treatment Cycle
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Assessment method [4]
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The assessment was made on a continuous 100-mm horizontal line with a scale range of 0 mm (no pain) to 100 mm (worst possible pain).
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Timepoint [4]
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Baseline and Week 4
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Secondary outcome [5]
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Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia Following First Treatment Cycle
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Assessment method [5]
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The assessment was made on a continuous 100-mm horizontal line with a scale range of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
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Timepoint [5]
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Baseline and Week 4
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Secondary outcome [6]
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Percentage of Treatment Responders Following First Treatment Cycle
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Assessment method [6]
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A treatment responder was defined as a patient with \>30% improvement in TWSTRS Total score compared to baseline.
TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.
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Timepoint [6]
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Baseline and Week 4
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Secondary outcome [7]
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Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score for Treatment Cycles 2 to 5
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Assessment method [7]
0
0
TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.
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Timepoint [7]
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Treatment cycle Baseline and Week 4
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Secondary outcome [8]
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Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Score for Treatment Cycles 2 to 5
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Assessment method [8]
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TWSTRS measures the degree of CD and comprises three different components, one of which is the Severity subscale. TWSTRS Severity subscale scores range from 0 (absence of severity) to 35 (maximum severity). If the change from baseline is negative, this represents an improvement in symptoms.
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Timepoint [8]
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Treatment cycle Baseline and Week 4
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Secondary outcome [9]
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Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Score for Treatment Cycles 2 to 5
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Assessment method [9]
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TWSTRS measures the degree of CD and comprises three different components, one of which is the Disability subscale. TWSTRS Disability subscale scores range from 0 (no disability) to 30 (maximum disability). If the change from baseline is negative, this represents an improvement in symptoms.
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Timepoint [9]
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Treatment cycle Baseline and Week 4
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Secondary outcome [10]
0
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Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score for Treatment Cycles 2 to 5
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Assessment method [10]
0
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TWSTRS measures the degree of CD and comprises three different components, one of which is the Pain subscale. TWSTRS Pain subscale scores range from 0 (no pain) to 20 (maximum pain). If the change from baseline is negative, this represents an improvement in symptoms.
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Timepoint [10]
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Treatment cycle Baseline and Week 4
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Secondary outcome [11]
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Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia for Treatment Cycles 2 to 5
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Assessment method [11]
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The assessment was made on a continuous 100-mm horizontal line with a scale range of 0 mm (no pain) to 100 mm (worst possible pain).
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Timepoint [11]
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Treatment cycle Baseline and Week 4
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Secondary outcome [12]
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Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia for Treatment Cycles 2 to 5
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Assessment method [12]
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The assessment was made on a continuous 100-mm horizontal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
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Timepoint [12]
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Treatment cycle Baseline and Week 4
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Secondary outcome [13]
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Percentage of Treatment Responders for Treatment Cycles 2 to 5
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Assessment method [13]
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A treatment responder was defined as a patient with \>30% improvement in TWSTRS Total score compared to baseline.
TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.
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Timepoint [13]
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Treatment cycle Baseline and Week 4
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Eligibility
Key inclusion criteria
* Dystonia with at least 18 months duration since onset.
* Previously untreated with Botulinum toxin-A (BTX-A) or -B or a minimum of 14 weeks since the last injection.
* TWSTRS score at baseline of: Total score = 30, Severity Sub-Scale score = 15, Disability Sub-Scale score = 3, Pain Sub-Scale score = 2.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Known hypersensitivity to Botulinum toxin (BTX) or related compounds or any component in the study drug formulation (including cow milk protein).
* Pure anterocollis or pure retrocollis.
* In apparent remission from Cervical Dystonia.
* Known clinically significant underlying swallowing or respiratory abnormality which might be exacerbated by BTX treatment.
* Previous poor response to BTX treatment or known presence of BTX neutralising antibodies.
* Previous phenol or alcohol injections into the neck muscles.
* Previous myotomy or denervation surgery involving the neck or shoulder region.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2013
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Sample size
Target
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Accrual to date
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Final
382
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash Medical Centre - Clayton
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Recruitment hospital [2]
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Austin Hospital - Heidelberg
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Recruitment hospital [3]
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Department of Neurosciences Alfred Hospital - Prahran
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Recruitment hospital [4]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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- Clayton
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Recruitment postcode(s) [2]
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- Heidelberg
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Recruitment postcode(s) [3]
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- Prahran
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Recruitment postcode(s) [4]
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- Westmead
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Recruitment outside Australia
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Austria
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Innsbruck
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Austria
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Wien
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Belgium
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Brugge
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Liège
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Belgium
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Roeselare
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Czechia
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Brno
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Czechia
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Pardubice
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Czechia
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Plzen
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Czechia
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Praha
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France
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Amiens
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France
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Bron
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France
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Nîmes
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France
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Pessac
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France
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Strasbourg
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France
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Toulouse
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Berlin
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Germany
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Bonn
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Germany
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Düsseldorf
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Germany
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Halle
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Germany
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Hannover
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Germany
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Leipzig
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Germany
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München
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Germany
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Tübingen
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Germany
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Wiesbaden
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Germany
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Würzburg
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Hungary
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Budapest
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Hungary
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Nyíregyháza
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Hungary
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Pécs
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Hungary
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Szeged
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Poland
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Gdansk
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Lodz
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Poznan
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Warszawa
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Portugal
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Lisboa
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Portugal
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Porto
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Samara
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Ukraine
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Chernivtsi
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Kharkiv
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Ukraine
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Lviv
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Ukraine
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Odessa
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Ukraine
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Uzhgorod
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Ukraine
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Vinnytsya
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ipsen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.
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Trial website
https://clinicaltrials.gov/study/NCT01261611
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Trial related presentations / publications
Poewe W, Burbaud P, Castelnovo G, Jost WH, Ceballos-Baumann AO, Banach M, Potulska-Chromik A, Ferreira JJ, Bihari K, Ehler E, Bares M, Dzyak LA, Belova AN, Pham E, Liu WJ, Picaut P. Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial. Mov Disord. 2016 Nov;31(11):1649-1657. doi: 10.1002/mds.26760. Epub 2016 Sep 21.
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Public notes
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Contacts
Principal investigator
Name
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Ipsen Medical Director
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Address
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Ipsen
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Fax
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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When will data be available (start and end dates)?
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
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Available to whom?
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/members/ourmembers/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01261611