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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01261611




Registration number
NCT01261611
Ethics application status
Date submitted
15/12/2010
Date registered
16/12/2010
Date last updated
24/09/2019

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
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
Secondary ID [1] 0 0
2010-019907-43
Secondary ID [2] 0 0
Y-52-52120-134
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Dystonia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Botulinum toxin type A
Other interventions - 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.


Other interventions: Botulinum toxin type A
I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.

Other interventions: 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.

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle - 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.
Timepoint [1] 0 0
Baseline and Week 4
Secondary outcome [1] 0 0
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Following First Treatment Cycle - 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.
Timepoint [1] 0 0
Baseline and Week 4
Secondary outcome [2] 0 0
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale Score Following First Treatment Cycle - 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.
Timepoint [2] 0 0
Baseline and Week 4
Secondary outcome [3] 0 0
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score Following First Treatment Cycle - 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.
Timepoint [3] 0 0
Baseline and Week 4
Secondary outcome [4] 0 0
Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia Following First Treatment Cycle - 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).
Timepoint [4] 0 0
Baseline and Week 4
Secondary outcome [5] 0 0
Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia Following First Treatment Cycle - 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).
Timepoint [5] 0 0
Baseline and Week 4
Secondary outcome [6] 0 0
Percentage of Treatment Responders Following First Treatment Cycle - 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.
Timepoint [6] 0 0
Baseline and Week 4
Secondary outcome [7] 0 0
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score for Treatment Cycles 2 to 5 - 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.
Timepoint [7] 0 0
Treatment cycle Baseline and Week 4
Secondary outcome [8] 0 0
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Score for Treatment Cycles 2 to 5 - 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.
Timepoint [8] 0 0
Treatment cycle Baseline and Week 4
Secondary outcome [9] 0 0
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Score for Treatment Cycles 2 to 5 - 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.
Timepoint [9] 0 0
Treatment cycle Baseline and Week 4
Secondary outcome [10] 0 0
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score for Treatment Cycles 2 to 5 - 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.
Timepoint [10] 0 0
Treatment cycle Baseline and Week 4
Secondary outcome [11] 0 0
Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia for Treatment Cycles 2 to 5 - 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).
Timepoint [11] 0 0
Treatment cycle Baseline and Week 4
Secondary outcome [12] 0 0
Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia for Treatment Cycles 2 to 5 - 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).
Timepoint [12] 0 0
Treatment cycle Baseline and Week 4
Secondary outcome [13] 0 0
Percentage of Treatment Responders for Treatment Cycles 2 to 5 - 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.
Timepoint [13] 0 0
Treatment cycle Baseline and Week 4

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Department of Neurosciences Alfred Hospital - Prahran
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Prahran
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Brugge
Country [4] 0 0
Belgium
State/province [4] 0 0
Edegem
Country [5] 0 0
Belgium
State/province [5] 0 0
Gent
Country [6] 0 0
Belgium
State/province [6] 0 0
Liège
Country [7] 0 0
Belgium
State/province [7] 0 0
Roeselare
Country [8] 0 0
Czechia
State/province [8] 0 0
Brno
Country [9] 0 0
Czechia
State/province [9] 0 0
Pardubice
Country [10] 0 0
Czechia
State/province [10] 0 0
Plzen
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha
Country [12] 0 0
France
State/province [12] 0 0
Amiens
Country [13] 0 0
France
State/province [13] 0 0
Bron
Country [14] 0 0
France
State/province [14] 0 0
Nîmes
Country [15] 0 0
France
State/province [15] 0 0
Pessac
Country [16] 0 0
France
State/province [16] 0 0
Strasbourg
Country [17] 0 0
France
State/province [17] 0 0
Toulouse
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Bonn
Country [20] 0 0
Germany
State/province [20] 0 0
Düsseldorf
Country [21] 0 0
Germany
State/province [21] 0 0
Halle
Country [22] 0 0
Germany
State/province [22] 0 0
Hannover
Country [23] 0 0
Germany
State/province [23] 0 0
Leipzig
Country [24] 0 0
Germany
State/province [24] 0 0
München
Country [25] 0 0
Germany
State/province [25] 0 0
Tübingen
Country [26] 0 0
Germany
State/province [26] 0 0
Wiesbaden
Country [27] 0 0
Germany
State/province [27] 0 0
Würzburg
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Hungary
State/province [29] 0 0
Nyíregyháza
Country [30] 0 0
Hungary
State/province [30] 0 0
Pécs
Country [31] 0 0
Hungary
State/province [31] 0 0
Szeged
Country [32] 0 0
Poland
State/province [32] 0 0
Gdansk
Country [33] 0 0
Poland
State/province [33] 0 0
Katowice
Country [34] 0 0
Poland
State/province [34] 0 0
Krakow
Country [35] 0 0
Poland
State/province [35] 0 0
Lodz
Country [36] 0 0
Poland
State/province [36] 0 0
Poznan
Country [37] 0 0
Poland
State/province [37] 0 0
Warszawa
Country [38] 0 0
Portugal
State/province [38] 0 0
Lisboa
Country [39] 0 0
Portugal
State/province [39] 0 0
Porto
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Kazan
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Moscow
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Nizhniy Novgorod
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Samara
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Smolensk
Country [45] 0 0
Russian Federation
State/province [45] 0 0
St. Petersburg
Country [46] 0 0
Ukraine
State/province [46] 0 0
Chernivtsi
Country [47] 0 0
Ukraine
State/province [47] 0 0
Dnipropetrovsk
Country [48] 0 0
Ukraine
State/province [48] 0 0
Donetsk
Country [49] 0 0
Ukraine
State/province [49] 0 0
Kharkiv
Country [50] 0 0
Ukraine
State/province [50] 0 0
Lviv
Country [51] 0 0
Ukraine
State/province [51] 0 0
Odessa
Country [52] 0 0
Ukraine
State/province [52] 0 0
Uzhgorod
Country [53] 0 0
Ukraine
State/province [53] 0 0
Vinnytsya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01261611
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications