Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000800224
Ethics application status
Approved
Date submitted
30/10/2008
Date registered
15/09/2009
Date last updated
11/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Observational study to determine the type of patient with cervical dystonia that responds best to botulinum toxin treatment
Scientific title
An international observational study to define factors influencing response to one Botulinum Toxin Type A (BoNT-A) injection cycle in subjects suffering from idiopathic cervical dystonia.
Secondary ID [1] 739 0
Y-79-52120-131. Ipsen.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Cervical Dystonia 3900 0
Condition category
Condition code
Neurological 4100 4100 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Botulinum Toxin Type A (BoNT-A) for idiopathic cervical dystonia. BoNT-A is able to stop nerves stimulating muscles thus providing a way of relaxing muscles. BoNT-A is administered by intramuscular injections with a duration of action of between 12 to 16 weeks. Observations will be made at 3-6 weeks post injection and again at the time of re-injection (12-16 weeks). The dosage given to the patient will be at the clinician's discretion.
Intervention code [1] 3626 0
Treatment: Drugs
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4992 0
To estimate the responder rate at peak effect following one BoNT-A injection cycle. Responders will be defined as those that have a clinically signficant improvement in severity of dystonia (medical assessment) with no safety issues (medical observations).
Timepoint [1] 4992 0
The outcome will be assessed at some time between 3-6 weeks post-injection according to patient and clinician availability.
Secondary outcome [1] 8428 0
Head and Neck Deviations by medical assessment/test.
Timepoint [1] 8428 0
Assessments will be undertaken 3-6 weeks and 12-16 weeks post injection according to patient and clinician availability.
Secondary outcome [2] 8429 0
Toronto Western Spasmodic Torticollis Rating Scale (TWSTR).
Timepoint [2] 8429 0
Assessment will be undertaken 3-6 weeks and 12-16 weeks post injection according to patient and clinician availability.
Secondary outcome [3] 8430 0
Tremor (from TSUI scale)
Timepoint [3] 8430 0
Assessment will be undertaken 3-6 weeks and 12-16 weeks post injection according to patient and clinician availability.
Secondary outcome [4] 8431 0
The Cervical Dystonia Impact Profile (CDIP-58).
Timepoint [4] 8431 0
Assessment will be undertaken 3-6 weeks post injection according to patient and clinician availability.
Secondary outcome [5] 8432 0
Clinical Global Improvement (single question questionnaire)
Timepoint [5] 8432 0
Assessment will be undertaken 3-6 weeks post injection according to patient and clinician availability.

Eligibility
Key inclusion criteria
Greater than or equal to 18 years of age with idiopathic cervical dystonia. Toronto Western Spasmodic Torticollis Rating Scale score of greater than or equal to 15 and at least 12 weeks since last BoNT-A Injection.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to BoNT-A
Secondary cervical dystonia

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4092 0
Commercial sector/Industry
Name [1] 4092 0
Ipsen
Country [1] 4092 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ipsen
Address
Suite 6 Montclair Ave, Glen Waverley, VIC 3150
Country
Australia
Secondary sponsor category [1] 3685 0
None
Name [1] 3685 0
Address [1] 3685 0
Country [1] 3685 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6161 0
Sydney West Area Health Service
Ethics committee address [1] 6161 0
Ethics committee country [1] 6161 0
Australia
Date submitted for ethics approval [1] 6161 0
Approval date [1] 6161 0
05/03/2009
Ethics approval number [1] 6161 0
1/09
Ethics committee name [2] 6867 0
Alfred Hospital Ethics Committee
Ethics committee address [2] 6867 0
Ethics committee country [2] 6867 0
Australia
Date submitted for ethics approval [2] 6867 0
Approval date [2] 6867 0
11/03/2009
Ethics approval number [2] 6867 0
2008/12/4.6
Ethics committee name [3] 6868 0
St Vincent's Hospital Melbourne Human Research Ethics
Ethics committee address [3] 6868 0
Ethics committee country [3] 6868 0
Australia
Date submitted for ethics approval [3] 6868 0
Approval date [3] 6868 0
15/01/2009
Ethics approval number [3] 6868 0
162/08
Ethics committee name [4] 6869 0
Austin Health Human Research Ethics Committee
Ethics committee address [4] 6869 0
Ethics committee country [4] 6869 0
Australia
Date submitted for ethics approval [4] 6869 0
Approval date [4] 6869 0
26/02/2009
Ethics approval number [4] 6869 0
H2009/03467

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29082 0
Address 29082 0
Country 29082 0
Phone 29082 0
Fax 29082 0
Email 29082 0
Contact person for public queries
Name 12239 0
Angela Gibbs
Address 12239 0
PO Box 820 Glen Waverley, Vic, 3150
Country 12239 0
Australia
Phone 12239 0
+61 3 85448100
Fax 12239 0
Email 12239 0
angela.gibbs@ipsen.com
Contact person for scientific queries
Name 3167 0
Monica de Abadal
Address 3167 0
PO Box 820 Glen Waverley, Vic, 3150
Country 3167 0
Australia
Phone 3167 0
+61 3 85448100
Fax 3167 0
Email 3167 0
monica.deabadal@ipsen.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.