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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00528541




Registration number
NCT00528541
Ethics application status
Date submitted
10/09/2007
Date registered
12/09/2007
Date last updated
16/12/2011

Titles & IDs
Public title
Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia
Scientific title
Secondary ID [1] 0 0
MedAff-BTX-0616
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spasmodic Torticollis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

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

Active Comparator: BOTOX® - botulinum toxin type A (BOTOX®)

Active Comparator: Dysport® - botulinum toxin type A (Dysport®)


Other interventions: botulinum toxin type A
200 Units at Visit 1 (Day 1)

Other interventions: botulinum toxin type A
750 Units at Visit 1 (Day 1)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dysphagia Incidence Over 10 Weeks - Dysphagia Incidence (difficulty swallowing) was defined as the number of patients reporting at least 1 treatment-emergent dysphagia event at any point in the study. Occurrences of dysphagia were captured as spontaneous events or were assessed during study visits using the Structured Symptom Interview (SSI) and the Dystonia Study Group Dysphagia Interview (DSGDI) for symptoms of difficulty swallowing; coughing while eating and drinking; choking while eating or drinking; or difficulty swallowing solids or liquids.
Timepoint [1] 0 0
10 weeks
Secondary outcome [1] 0 0
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4 - The TWSTRS assessments were conducted at each study visit. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. It 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.
Timepoint [1] 0 0
Baseline, Week 4
Secondary outcome [2] 0 0
Physician Assessment of Cervical Dystonia Severity at Week 4 - Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever.'
Timepoint [2] 0 0
Baseline, Week 4
Secondary outcome [3] 0 0
Global Assessment of Benefit by Physician at Week 4 - Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'
Timepoint [3] 0 0
Week 4
Secondary outcome [4] 0 0
Global Assessment of Benefit by Patient at Week 4 - Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'
Timepoint [4] 0 0
Week 4
Secondary outcome [5] 0 0
Patient Assessment of Need for Retreatment at Week 4 - Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer "How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?". The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection' and 'does not require injection'.
Timepoint [5] 0 0
Baseline, Week 4
Secondary outcome [6] 0 0
Patient Visual Analog Assessment of Pain at Week 4 - Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.
Timepoint [6] 0 0
Baseline, Week 4
Secondary outcome [7] 0 0
Physician Comparison of Benefit to Previous Injections at Week 10 - Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.
Timepoint [7] 0 0
Week 10
Secondary outcome [8] 0 0
Patient Comparison of Benefit to Previous Injections at Week 10 - Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.
Timepoint [8] 0 0
Week 10

Eligibility
Key inclusion criteria
- Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months

- Successfully treated previously with botulinum toxin type A
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Breast feeding, pregnant or could become pregnant

- Surgery or spinal cord stimulation for cervical dystonia

- Previous injections of phenol, alcohol for cervical dystonia

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
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)
SA
Recruitment hospital [1] 0 0
- Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Croatia
State/province [1] 0 0
Zagreb
Country [2] 0 0
Italy
State/province [2] 0 0
Rome
Country [3] 0 0
Poland
State/province [3] 0 0
Krakow
Country [4] 0 0
Turkey
State/province [4] 0 0
Istanbul

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare two types of botulinum toxin type A to treat the
involuntary muscle contractions in the neck
Trial website
https://clinicaltrials.gov/show/NCT00528541
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
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