- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04270214
Conversion to Dysport in CD
June 29, 2022 updated by: Mandar Jog, Western University, Canada
Conversion and Optimization of Dysport for Cervical Dystonia
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Dysport
Single arm study, all participants will receive Dysport injections
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Dysport injections optimized using kinematics
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
waning effect
Time Frame: within 12 weeks of treatment
|
telephone call report of when participant perceives benefit of treatment is wearing off
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within 12 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective measures of CD severity
Time Frame: 4-weeks and 12-weeks post-treatment
|
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).
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4-weeks and 12-weeks post-treatment
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changes in TMS measures
Time Frame: 4-weeks and 12-weeks post-treatment
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changes in brain activity (inhibitory and excitatory pathways) using paired pulse TMS.
Using established techniques
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4-weeks and 12-weeks post-treatment
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visual-motor performance
Time Frame: 4-weeks and 12-weeks post-treatment
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speed, reaction time and accuracy in completing upper limb target reaching choice tasks using a robotic haptic device
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4-weeks and 12-weeks post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
February 12, 2020
First Submitted That Met QC Criteria
February 12, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
July 5, 2022
Last Update Submitted That Met QC Criteria
June 29, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Movement Disorders
- Dyskinesias
- Dystonia
- Dystonic Disorders
- Torticollis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- abobotulinumtoxinA
Other Study ID Numbers
- 115308
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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