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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - botulinum toxin type A
Treatment: Other - botulinum toxin type A

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

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


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

Treatment: Other: botulinum toxin type A
750 Units at Visit 1 (Day 1)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dysphagia Incidence Over 10 Weeks
Timepoint [1] 0 0
10 weeks
Secondary outcome [1] 0 0
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4
Timepoint [1] 0 0
Baseline, Week 4
Secondary outcome [2] 0 0
Physician Assessment of Cervical Dystonia Severity at Week 4
Timepoint [2] 0 0
Baseline, Week 4
Secondary outcome [3] 0 0
Global Assessment of Benefit by Physician at Week 4
Timepoint [3] 0 0
Week 4
Secondary outcome [4] 0 0
Global Assessment of Benefit by Patient at Week 4
Timepoint [4] 0 0
Week 4
Secondary outcome [5] 0 0
Patient Assessment of Need for Retreatment at Week 4
Timepoint [5] 0 0
Baseline, Week 4
Secondary outcome [6] 0 0
Patient Visual Analog Assessment of Pain at Week 4
Timepoint [6] 0 0
Baseline, Week 4
Secondary outcome [7] 0 0
Physician Comparison of Benefit to Previous Injections at Week 10
Timepoint [7] 0 0
Week 10
Secondary outcome [8] 0 0
Patient Comparison of Benefit to Previous Injections at Week 10
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
Sex
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
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
145
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00528541