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Conversion to Dysport in CD

Primary Purpose

Cervical Dystonia

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dysport Injectable Product
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia focused on measuring botulinum toxin type A

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    1. Receiving BoNT-A for other indications (e.g. upper limb tremor)
    2. if you have a history of seizures.
    3. 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.
    4. 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.
    5. 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.
    6. 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.
    7. allergy to cow's milk protein

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dysport

Arm Description

Single arm study, all participants will receive Dysport injections

Outcomes

Primary Outcome Measures

waning effect
telephone call report of when participant perceives benefit of treatment is wearing off

Secondary Outcome Measures

objective measures of CD severity
Kinematic sensor technology is used to measure CD symptoms (neck pulling and/or tremor). Sensors coupled with computer-assisted analysis can measure degrees of deviation from neutral head/neck position and angular root mean square tremor/dystonic jerks amplitude in each plane of motion (vertical, lateral, rotational).
changes in TMS measures
changes in brain activity (inhibitory and excitatory pathways) using paired pulse TMS. Using established techniques
visual-motor performance
speed, reaction time and accuracy in completing upper limb target reaching choice tasks using a robotic haptic device

Full Information

First Posted
February 12, 2020
Last Updated
June 29, 2022
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04270214
Brief Title
Conversion to Dysport in CD
Official Title
Conversion and Optimization of Dysport for Cervical Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
Keywords
botulinum toxin type A

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dysport
Arm Type
Other
Arm Description
Single arm study, all participants will receive Dysport injections
Intervention Type
Drug
Intervention Name(s)
Dysport Injectable Product
Other Intervention Name(s)
abobotulinumtoxinA
Intervention Description
Dysport injections optimized using kinematics
Primary Outcome Measure Information:
Title
waning effect
Description
telephone call report of when participant perceives benefit of treatment is wearing off
Time Frame
within 12 weeks of treatment
Secondary Outcome Measure Information:
Title
objective measures of CD severity
Description
Kinematic sensor technology is used to measure CD symptoms (neck pulling and/or tremor). Sensors coupled with computer-assisted analysis can measure degrees of deviation from neutral head/neck position and angular root mean square tremor/dystonic jerks amplitude in each plane of motion (vertical, lateral, rotational).
Time Frame
4-weeks and 12-weeks post-treatment
Title
changes in TMS measures
Description
changes in brain activity (inhibitory and excitatory pathways) using paired pulse TMS. Using established techniques
Time Frame
4-weeks and 12-weeks post-treatment
Title
visual-motor performance
Description
speed, reaction time and accuracy in completing upper limb target reaching choice tasks using a robotic haptic device
Time Frame
4-weeks and 12-weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Conversion to Dysport in CD

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