NCT04270214

Conversion to Dysport in CD

Conversion and Optimization of Dysport for Cervical Dystonia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Western University, Canada · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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. It is unclear whether there are differences in the neurophysiological effects between BoNT-A formulations, such as blocking spinal afferent signals from proprioceptive mechanoreceptors of the injected muscles contributing to CD or the modulation of cortical activity \[8\]. The underlying pathophysiology of impaired motor control in CD is theorized to be caused by abnormal somatosensory processing that affects proprioceptive and tactile function \[8\]. By altering the processing of proprioceptive signals from the muscles to the cortical somatosensory-motor areas, proprioceptive perception can be modulated and possibly normalize activity of the somatosensory-motor areas in CD. Thus, it is hypothesized that BoNT-A may indirectly modulate these cortical pathways and Dysport may have a longer modulatory effect to produce a longer lasting clinical response.

Conditions

• Cervical Dystonia

Interventions

Type	Name	Description
DRUG	Dysport Injectable Product	Dysport injections optimized using kinematics

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2020-02-17
• Last updated: 2022-07-05

Locations

1 site across 1 country: Canada