Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00432341




Registration number
NCT00432341
Ethics application status
Date submitted
5/02/2007
Date registered
7/02/2007
Date last updated
16/12/2011

Titles & IDs
Public title
Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia
Scientific title
Secondary ID [1] 0 0
MedAff-BTX-0615
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

Experimental: 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
500 Units at Visit 1 (Day 1)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of Treatment Benefit
Timepoint [1] 0 0
20 Weeks
Secondary outcome [1] 0 0
Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4
Timepoint [1] 0 0
Week 4
Secondary outcome [2] 0 0
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4
Timepoint [2] 0 0
Baseline, Week 4
Secondary outcome [3] 0 0
Global Assessment of Benefit by Patient at Week 4
Timepoint [3] 0 0
Week 4
Secondary outcome [4] 0 0
Global Assessment of Benefit by Physician at Week 4
Timepoint [4] 0 0
Week 4
Secondary outcome [5] 0 0
Physician Assessment of Cervical Dystonia Severity at Week 4
Timepoint [5] 0 0
Baseline, Week 4
Secondary outcome [6] 0 0
Physician Comparison of Benefit to Previous Injections at Week 20
Timepoint [6] 0 0
Week 20
Secondary outcome [7] 0 0
Patient Comparison of Benefit to Previous Injections at Week 20
Timepoint [7] 0 0
Week 20
Secondary outcome [8] 0 0
Patient Visual Analog Assessment of Pain at Week 4
Timepoint [8] 0 0
Baseline, Week 4
Secondary outcome [9] 0 0
Patient Assessment of Need for Retreatment at Week 4
Timepoint [9] 0 0
Baseline, Week 4

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
75 Years
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
India
State/province [2] 0 0
New Delhi

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/NCT00432341
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/NCT00432341