Cervical Dystonia, PrimaryPhase 4NCT06886750
The Effects of Waning of Botulinum Toxin in the Treatment of Cervical Dystonia
A Phase 4 study testing Botulinum toxin type A injection in people with Cervical Dystonia, Primary, run by Western University, Canada.
Trial summary
The main treatment for cervical dystonia is botulinum toxin injections. However, some patients receiving this treatment after many years tend to experience short duration of benefit. Typically, botulinum toxin brands used in clinic are Botox or Xeomin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Dystonia, Primary
- What is being tested?
- Botulinum toxin type A injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2025to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or above with a diagnosis of isolated CD
- Experience efficacious relief with a waning time of ≤8 weeks post-injection
- Must have received the same dose and injection pattern of onaBoNT-A or incoBoNT-A for at least 3 injection cycles prior to study initiation with an injection cycle of 12 weeks
Who cannot join
- Require a total dose <80 U or >300 U ona/incoBoNT-A
- Pure reterocollis or suspected secondary non-responsiveness
- No interest in switching between BoNT-A formulations
- Prolonged history of dysphagia
- History of poor response to BoNT-A or BoNT-B
- Inability to complete study visits or sign informed consent
Show all 9Show fewer
- Pregnancy
- Known resistance or contradictions to any BoNT-A
- Known hypersensitivity to BoNT-A or related compound
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Rachna Jog, MBA contact
About this study
Official title: Investigation of Waning Time in Patients With Cervical Dystonia Converted to Botulinum Toxin A
The main treatment for cervical dystonia is botulinum toxin injections. However, some patients receiving this treatment after many years tend to experience short duration of benefit. Typically, botulinum toxin brands used in clinic are Botox or Xeomin. Another type of botulinum toxin is called Dysport (Ipsen Biopharmaceuticals), and Dysport may increase duration of benefit from the injections. The study is selecting patients from the investigator's clinics who are not satisfied with the duration of their treatment and are willing to switch to Dysport and the investigators will monitor if Dysport will increase the duration of benefit over a total of 3 treatments. A group of patients will be switched to Dysport while another group will remain on their original botulinum toxin formulation. The patients will be unaware of the treatment switch and hence are considered to be blinded. The investigators will not be blinded. Treatments are given every 3 months. All study visits will occur at the local sites of the 3 recruiting sites.
Read the detailed description
Cervical dystonia (CD) is a disabling and often painful condition clinically characterized by abnormal neck and head postures and movements often associated with tremor and chronic pain. Botulinum toxin type A (BoNT-A) is an effective and safe first-line therapy for CD. However, in a recent patient perspective survey, symptom re-emergence between injections (a mean 10.5 weeks) was reported in 88% of patients with a waning time of ≤8 weeks in one-third of patients. Waning treatment effects prior to re-injection reduces quality of life as 47% of patients are somewhat satisfied, and 39% were not satisfied with their therapy as symptoms may follow a "yo-yo" pattern . 45% of patients would prefer a ≤10-week treatment cycle due to the short therapeutic response. However, practicality of injecting patients more frequently and concerns about potential immunologically mediated resistance to BoNT-A has resulted in a standard of treating at intervals of at least 12 weeks. Thus, a significant unmet need is a long-lasting therapy that delays symptom re-emergence and may improve patient satisfaction and outcomes.
Nine published clinical studies have studied the direct comparison between Botox and Dysport in CD patients and authors concluded that a simple dose-conversion factor is not applicable as the ratio for Botox to Dysport was extremely variable, ranging from 1.2 to 13.3. Yun et al demonstrated that conversion to Dysport using a Botox:Dysport ratio of 1:2.5 was not inferior to Botox. A double blind, crossover study lasting 3 injection cycles studied 2 ratios (1:3 and 1:4) and found at both conversion ratios, Dysport was superior to Botox in terms of symptom reduction and duration of effect, although higher frequency of adverse effects such as dysphagia was reported. More recently, a double-blind, randomized crossover study evaluated 2 conversion ratios (1:3 and 1:1.7) that did not show any differences in efficacy in the short term, but the effect of Botox was reduced after 3 months. At week 12, a statistically significant difference in efficacy between abobotulinumtoxinA and onabotulinumtoxinA (1:3) was observed, suggesting a shorter duration of effect for the latter when this ratio (at low dose) was used. Thus, in this research study, the objective is to determine if conversion ratio of 1:2.5 (Botox:Dysport) from the patient's optimized, stable treatment (either Botox or Xeomin) can increase duration of BoNT-A efficacy.
A pilot study published by our research group reported a significant increase in waning time and efficacy following the conversion to aboBoNT-A in 27 CD patients who had a waning time of ≤8-weeks on their original BoNT-A formulation (either onaBoNT-A/incoBoNT-A). The results of the pilot study were limited by the lack of participant blinding and absence of a control group. Thus, a randomized, controlled, single-blind study will be conducted to determine whether the conversion to aboBoNT-A affects waning time, clinical outcomes and treatment satisfaction in patients experiencing early waning with ona/incoBoNT-A.
- Conditions
- Cervical Dystonia, Primary
- Being tested
- Botulinum toxin type A injection
- Keywords
- botulinum toxin injections, waning effect, dystonia
- Medical subject headings
- Cervical Dystonia, Primary, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A injectionDrug
Injection of toxin
| Study group | Role | What they receive |
|---|---|---|
| aboBoNT-A | Active comparator | 1. Next 3 injections (every 12 weeks) are using aboBoNT-A (Dysport)
2. First Dysport injection: 1:2.5 ona/incoBoNT-A: aboBoNT-A dose ratio conversion (reconstitution is 2 ml in a 500 U aboBoNT-A vial) (V1)
3. Second and third injection: clinical optimization of aboBoNT-A dosing pattern at 12-weeks post aboBoNT-A injection. (V2 and V3). The 12 week period is compulsory.
4. Return to original BoNT-A formulation (1:2.5 ona/incoBoNT-A: aboBoNT-A dose ratio), using same injection pattern as V3 (V4)
5. Non-injection final study visit to conduct all assessments (V5) Receives: Drug: Botulinum toxin type A injection |
| Original toxin arm | Active comparator | 1. Next 3 injections (every 12 weeks) are the same toxin as the original
2. First injection: Dose may be optimized as per the investigators discretion or kept the same (reconstitution is 1 ml in a 100 U ona/incoBoNT-A vial) (V1)
3. Second and third injection: clinical optimization of the dose as required with dosing pattern at weeks 12 post injection. (V2 and V3). The 12 week period is compulsory.
4. Continue with the original toxin, using same injection pattern as V3 (V4)
5. Non-injection final study visit to conduct all assessments (V5) Receives: Drug: Botulinum toxin type A injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waining time.
Waning time - time from last injection to participant perception of treatment effects starting to wear off. An increase in waning time is a better outcome. Values will be between 8 to 12 weeks.
Measured: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.
Secondary outcomes (4)
• Modified Tsui Scale
- Modified Tsui Scale for assessment of severity of cervical dystonia. A lower score is an improvement in outcome. Minimum value is 0 and maximum value is 18.
Measured: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.
• 5-point Likert participant reported treatment satisfaction tool
- 5-point Likert participant reported treatment satisfaction tool of injection of botulinum toxin for cervical dystonia. . A higher score on the scale denotes an improvement in the symptoms of cervical dystonia. Minimum value is 0 and maximum value is 5.
Measured: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.
• Onset of treatment relief using the symptom tracker
- Onset of treatment relief using the symptom tracker. This is the time at which point improvement in the symptoms of cervical dystonia are noted by the participant.
Measured: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.
• Safety of the use of botulinum toxin injection for cervical dystonia
- Safety will be measured as reported side effects by the patient from the injection of botulinum toxin for cervical dystonia. Treatment related adverse events will be documented and commented upon as related or unrelated to the treatment. This will be documented at every 12 week clinic visit.
Measured: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start30 Mar 2025 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Dystonia, PrimaryStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Manjog Enterprises Limited
- Responsible party
- Sponsor
- Investigators
- Mandar Jog, MD, Principal investigator, Univ of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886750
- Sponsor's protocol ID
- Dysportstudy1
- Status last verified
- Jan 2025
- First submitted
- 20 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Samotus O, Jog M. Conversion to AbobotulinumtoxinA Increases Waning Time and Efficacy for Cervical Dystonia. Mov Disord Clin Pract. 2023 Mar 1;10(5):756-763. doi: 10.1002/mdc3.13696. eCollection 2023 May.
PubMed 37205243
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Waning Time in Patients With Cervical Dystonia Converted to Botulinum Toxin A
- ClinicalTrials.gov ID
- NCT06886750
- Acronym / sponsor ID
- Dysportstudy1
- Conditions
- Cervical Dystonia, Primary
- Keywords
- botulinum toxin injections, waning effect, dystonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Manjog Enterprises Limited
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 Mar 2025 (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 main treatment for cervical dystonia is botulinum toxin injections. However, some patients receiving this treatment after many years tend to experience short duration of benefit. Typically, botulinum toxin brands used in clinic are Botox or Xeomin. Another type of botulinum toxin is called Dysport (Ipsen Biopharmaceuticals), and Dysport may increase duration of benefit from the injections. The study is selecting patients from the investigator's clinics who are not satisfied with the duration of their treatment and are willing to switch to Dysport and the investigators will monitor if Dysport will increase the duration of benefit over a total of 3 treatments. A group of patients will be switched to Dysport while another group will remain on their original botulinum toxin formulation. The patients will be unaware of the treatment switch and hence are considered to be blinded. The investigators will not be blinded. Treatments are given every 3 months. All study visits will occur at the local sites of the 3 recruiting sites.
Detailed description
Cervical dystonia (CD) is a disabling and often painful condition clinically characterized by abnormal neck and head postures and movements often associated with tremor and chronic pain. Botulinum toxin type A (BoNT-A) is an effective and safe first-line therapy for CD. However, in a recent patient perspective survey, symptom re-emergence between injections (a mean 10.5 weeks) was reported in 88% of patients with a waning time of ≤8 weeks in one-third of patients. Waning treatment effects prior to re-injection reduces quality of life as 47% of patients are somewhat satisfied, and 39% were not satisfied with their therapy as symptoms may follow a "yo-yo" pattern . 45% of patients would prefer a ≤10-week treatment cycle due to the short therapeutic response. However, practicality of injecting patients more frequently and concerns about potential immunologically mediated resistance to BoNT-A has resulted in a standard of treating at intervals of at least 12 weeks. Thus, a significant unmet need is a long-lasting therapy that delays symptom re-emergence and may improve patient satisfaction and outcomes.
Nine published clinical studies have studied the direct comparison between Botox and Dysport in CD patients and authors concluded that a simple dose-conversion factor is not applicable as the ratio for Botox to Dysport was extremely variable, ranging from 1.2 to 13.3. Yun et al demonstrated that conversion to Dysport using a Botox:Dysport ratio of 1:2.5 was not inferior to Botox. A double blind, crossover study lasting 3 injection cycles studied 2 ratios (1:3 and 1:4) and found at both conversion ratios, Dysport was superior to Botox in terms of symptom reduction and duration of effect, although higher frequency of adverse effects such as dysphagia was reported. More recently, a double-blind, randomized crossover study evaluated 2 conversion ratios (1:3 and 1:1.7) that did not show any differences in efficacy in the short term, but the effect of Botox was reduced after 3 months. At week 12, a statistically significant difference in efficacy between abobotulinumtoxinA and onabotulinumtoxinA (1:3) was observed, suggesting a shorter duration of effect for the latter when this ratio (at low dose) was used. Thus, in this research study, the objective is to determine if conversion ratio of 1:2.5 (Botox:Dysport) from the patient's optimized, stable treatment (either Botox or Xeomin) can increase duration of BoNT-A efficacy.
A pilot study published by our research group reported a significant increase in waning time and efficacy following the conversion to aboBoNT-A in 27 CD patients who had a waning time of ≤8-weeks on their original BoNT-A formulation (either onaBoNT-A/incoBoNT-A). The results of the pilot study were limited by the lack of participant blinding and absence of a control group. Thus, a randomized, controlled, single-blind study will be conducted to determine whether the conversion to aboBoNT-A affects waning time, clinical outcomes and treatment satisfaction in patients experiencing early waning with ona/incoBoNT-A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind study
| Arm | Type | Receives |
|---|---|---|
| aboBoNT-A | Active comparator | Drug: Botulinum toxin type A injection1. Next 3 injections (every 12 weeks) are using aboBoNT-A (Dysport) 2. First Dysport injection: 1:2.5 ona/incoBoNT-A: aboBoNT-A dose ratio conversion (reconstitution is 2 ml in a 500 U aboBoNT-A vial) (V1) 3. Second and third injection: clinical optimization of aboBoNT-A dosing pattern at 12-weeks post aboBoNT-A injection. (V2 and V3). The 12 week period is compulsory. 4. Return to original BoNT-A formulation (1:2.5 ona/incoBoNT-A: aboBoNT-A dose ratio), using same injection pattern as V3 (V4) 5. Non-injection final study visit to conduct all assessments (V5) |
| Original toxin arm | Active comparator | Drug: Botulinum toxin type A injection1. Next 3 injections (every 12 weeks) are the same toxin as the original 2. First injection: Dose may be optimized as per the investigators discretion or kept the same (reconstitution is 1 ml in a 100 U ona/incoBoNT-A vial) (V1) 3. Second and third injection: clinical optimization of the dose as required with dosing pattern at weeks 12 post injection. (V2 and V3). The 12 week period is compulsory. 4. Continue with the original toxin, using same injection pattern as V3 (V4) 5. Non-injection final study visit to conduct all assessments (V5) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or above with a diagnosis of isolated CD
- Experience efficacious relief with a waning time of ≤8 weeks post-injection
- Must have received the same dose and injection pattern of onaBoNT-A or incoBoNT-A for at least 3 injection cycles prior to study initiation with an injection cycle of 12 weeks
Key exclusion criteria (9 listed)
- Require a total dose <80 U or >300 U ona/incoBoNT-A
- Pure reterocollis or suspected secondary non-responsiveness
- No interest in switching between BoNT-A formulations
- Prolonged history of dysphagia
- History of poor response to BoNT-A or BoNT-B
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 |
|---|---|---|
| Botulinum toxin type A injectionInjection of toxin | Drug | Original toxin arm, aboBoNT-A |
Primary outcome
Waining time.
Time frame: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.
Waning time - time from last injection to participant perception of treatment effects starting to wear off. An increase in waning time is a better outcome. Values will be between 8 to 12 weeks.
4 secondary outcomes
• Modified Tsui Scale
Time frame: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.
• 5-point Likert participant reported treatment satisfaction tool
Time frame: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.
• Onset of treatment relief using the symptom tracker
Time frame: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.
• Safety of the use of botulinum toxin injection for cervical dystonia
Time frame: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Results publication: PubMed 37205243Samotus O, Jog M. Conversion to AbobotulinumtoxinA Increases Waning Time and Efficacy for Cervical Dystonia. Mov Disord Clin Pract. 2023 Mar 1;10(5):756-763. doi: 10.1002/mdc3.13696. eCollection 2023 May.
- Individual participant dataSharing planned: No
Related trials for Cervical Dystonia, Primary
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Active, not recruitingObservational study
An Observational Study of Individuals With Isolated Dystonia
Isolated/Primary Dystonia That Affects More Than One Region of the Body
Active, not recruiting
Segmental Muscle Vibration on Pain in Patients With Primary Cervical Dystonia
Primary Cervical Dystonia
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.
Rachna Jog, MBA contact
Mandar Jog, MD principal investigator
Univ of Western Ontario
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin type A injection in people with Cervical Dystonia, Primary, run by Western University, 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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mandar S Jog, MD (5196633814, mandar.jog@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waining time. (time frame: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06886750, which also lists 1 linked publication.
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 20 Mar 2025.