Status:
UNKNOWN
Conversion to Dysport in CD
Lead Sponsor:
Western University, Canada
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The first line of therapy for cervical dystonia patients is botulinum toxin injections, however injection parameter determination and optimization are challenging for physicians to do. In addition, so...
Eligibility Criteria
Inclusion
- Patients with cervical dystonia
- Patients experiencing early waning off (benefit for up to 8 weeks) of their current BoNT-A treatment (stable for at least 3 treatments)
- Only those that want to switch to Dysport will be included.
- No prior exposure to Dysport
- Able to come for multiple visits
- Patient's injection parameters are stable for ≥3 cycles
- Patient can provide written consent
Exclusion
- Unable to come for study visits
- Receiving BoNT-A for other indications (e.g. upper limb tremor)
- if you have a history of seizures.
- Pregnancy or Nursing: If you are pregnant then you ARE NOT ELIGIBLE FOR THIS STUDY. Please notify the research team if you are presently pregnant or if you are attempting to become pregnant or if you become pregnant at any time during the course of the study. A researcher will ask you about pregnancy at every study visit. If you are nursing, you ARE NOT ELIGIBLE FOR THIS STUDY. Please notify the researcher. Results from a pregnancy test will confirm your pregnancy status.
- Other Muscle/Nerve diseases: If you have a disease called Myasthenia Gravis or Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease) then you ARE NOT ELIGIBLE FOR THIS STUDY. Please notify the research team if you have these conditions.
- Previous side effects to botulinum toxin: If you have had a previous allergic reaction or side effect to botulinum toxin then you MAY NOT BE ELIGIBLE FOR THIS STUDY. Pease notify the research team if you have had a previous reaction/side effects from injection of botulinum toxin.
- Myotomy or denervation surgery: If you have had previous surgery for a myotomy or denervation of the neck or shoulder region then you ARE NOT ELIGIBLE FOR THIS STUDY. Please notify the research team if you have ever had these surgeries.
- allergy to cow's milk protein
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04270214
Start Date
June 1 2020
End Date
October 1 2022
Last Update
July 5 2022
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5