Cervical DystoniaNCT04270214
Conversion to Dysport in CD
A study testing Dysport Injectable Product in people with Cervical Dystonia, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Dysport Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2020to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cervical Dystonia
- Being tested
- Dysport Injectable Product
- Keywords
- botulinum toxin type A
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dysport Injectable ProductDrug
Also called abobotulinumtoxinA
Dysport injections optimized using kinematics
| Study group | Role | What they receive |
|---|---|---|
| Dysport | Other | Single arm study, all participants will receive Dysport injections Receives: Drug: Dysport Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
waning effect
telephone call report of when participant perceives benefit of treatment is wearing off
Measured: within 12 weeks of treatment
Secondary outcomes (3)
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).
Measured: 4-weeks and 12-weeks post-treatment
changes in TMS measures
changes in brain activity (inhibitory and excitatory pathways) using paired pulse TMS. Using established techniques
Measured: 4-weeks and 12-weeks post-treatment
visual-motor performance
speed, reaction time and accuracy in completing upper limb target reaching choice tasks using a robotic haptic device
Measured: 4-weeks and 12-weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jun 2020
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandar Jog, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270214
- Sponsor's protocol ID
- 115308
- Status last verified
- Jun 2022
- First submitted
- 12 Feb 2020
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion and Optimization of Dysport for Cervical Dystonia
- ClinicalTrials.gov ID
- NCT04270214
- Acronym / sponsor ID
- 115308
- Conditions
- Cervical Dystonia
- Keywords
- botulinum toxin type A
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dysport | Other | Drug: Dysport Injectable ProductSingle arm study, all participants will receive Dysport injections |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Unable to come for study visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dysport Injectable ProductAlso: abobotulinumtoxinADysport injections optimized using kinematics | Drug | Dysport |
Primary outcome
waning effect
Time frame: within 12 weeks of treatment
telephone call report of when participant perceives benefit of treatment is wearing off
3 secondary outcomes
objective measures of CD severity
Time frame: 4-weeks and 12-weeks post-treatment
changes in TMS measures
Time frame: 4-weeks and 12-weeks post-treatment
visual-motor performance
Time frame: 4-weeks and 12-weeks post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dysport Injectable Product in people with Cervical Dystonia, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
waning effect (time frame: within 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.