Conversion to Dysport in Cervical Dystonia Patients

• Status: Not yet recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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, some patients receiving this treatment long-term experience short duration of relief. Thus, Dysport (Ipsen Biopharmaceuticals), another BoNT-A formulation, may increase the duration of clinical benefit. The objective of this study is to compare the wearing off time of their original BoNT-A formulation (same injection parameters for at least 3 cycles) and the optimized treatment of Dysport (after 2 injection cycles). Ideally, the clinical benefits should last 2.5 - 3 months as injections are administered every 3 months. Conversion to Dysport will be conducted and optimization of Dysport dosing will be done using our sensor-technology assessment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western University, Canada
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• 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 Criteria:

• Unable to come for study visits

• Not interested in switching

• Total dose of original BoNT-A formulation exceeds 360 U of Botox or 300 U of Xeomin

• Pregnant and/or lactating females

• Known resistance to any BoNT-A

• Known hypersensitivity to BoNT-A or related compounds, or any component in the study drug formulation

• In the opinion of the investigator, the subject is unable and/or unwilling to comply fully with the protocol and the study instructions