Cervical DystoniaPhase 4NCT00773253
Botox for Cervical Dystonia Following EMG Mapping
A Phase 4 study testing Botulinum toxin A in people with Cervical Dystonia, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine how to improve treatment of patients with cervical dystonia who have not been helped with standard Botox injections. This study is for patients with cervical dystonia who have not benefited from treatment with Botox using conventional "single lead electromyographic (EMG)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Botulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jan 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18 to 75 years of age.
- Ability to follow study instructions and complete all required visits.
- Subject meets diagnostic criteria for idiopathic primary cervical dystonia.
- Subject has at least moderate severity Cervical Dystonia, with a baseline rating of at least 30 on the total TWSTRS and at least 15 on the TWSTRS motor severity subsection.
- Patients have had a suboptimal response to 2 previous Botulinum toxin injections at an outside facility.
- Patients will not have received Botulinum toxin within 16 weeks of the start of the study.
- In order to not confound the clinical response to BTX-A injections, all patients enrolled must have been on a stable medication regimen for 30 days. If they are not on medication at the initiation of the study, they will not be started on medication. Patients must be on the same medication regimen through the entire study including assessment of both single lead EMG based injections and "mapping" based injections. Medications cannot be stopped during the study to avoid confounding the clinical response to BTX-A.
Who cannot join
- Known allergy or sensitivity to any of the components in BTX-A.
- Uncontrolled clinically significant medical condition other than the condition under evaluation
- Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Participation in another medication or device study or within 3 months of enrollment in this study.
- Patients know to have a positive frontalis test or have previously tested positive for the presence of BTX-A antibodies will be excluded.
- Any known evidence of cervical contractures or significant spinal deformity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Pre-injection, Multi-channel EMG Mapping to Optimize Botulinum Toxin Type A Efficacy in Cervical Dystonia.
The purpose of this study is to determine how to improve treatment of patients with cervical dystonia who have not been helped with standard Botox injections. This study is for patients with cervical dystonia who have not benefited from treatment with Botox using conventional "single lead electromyographic (EMG) techniques" for injection. The study aim is to see if these patients may have significantly more benefit if their Botox is injected into muscles that have been chosen with a multi-channel EMG mapping study of the neck prior to Botox injection.
Read the detailed description
The most common type of primary late-onset dystonia is cervical dystonia. Botulinum toxin A (BTX-A) injections are a safe and effective treatment for cervical dystonia in a majority of patients, however, a significant minority of patients (between 15 and 25%) have a suboptimal response to Botulinum toxin therapy. It is unclear why some patients do not respond maximally to neurotoxin therapy.
Studies using needle electromyographic "mapping" in the evaluation of cervical dystonia have revealed that clinical examination alone is insufficient for determining which muscles contribute to the dystonic movement. When compared to needle electromyography (EMG) "mapping studies", experienced movement disorders specialists correctly identify only 59% of active muscles and believe that 25% of muscles which upon EMG evaluation are found to be quiescent, are involved in the dystonia. The selection of incorrect muscles for injection of Botulinum toxin may explain why some patients have a sub-optimal response.
This study seeks to measure outcomes when the muscles involved in dystonia are identified using "mapping" via an 8-12 channel EMG. In the proposed study, the most involved/active dystonic muscles will be correctly identified through simultaneous 8-12 channel mapping resulting in a more informed injection strategy, which may improve response to Botulinum toxin A treatment as compared to single lead EMG based injections. This study changes routine clinical care only by adding the step of studying the muscles of the neck with simultaneous EMG mapping to allow a more objective injection strategy.
- Conditions
- Cervical Dystonia
- Being tested
- Botulinum toxin A
- Keywords
- dystonia, cervical dystonia, Botox, idiopathic primary cervical dystonia
- Medical subject headings
- Torticollis, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin ADrug
Also called Botox
All patients will be treated with Botox using both single-channel and multi-channel EMG mapping.
| Study group | Role | What they receive |
|---|---|---|
| standard EMG-guided Botox injection | Active comparator | All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm. Receives: Drug: Botulinum toxin A |
| Multi-channel EMG-guided Botox injection | Experimental | Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design. Receives: Drug: Botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)
Measured: pre-injection, week 16, 20, 36, and 40
Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale
Mean Percentage change in Toronto Western Spasmodic Torticollis Rating Scale. This scale ranges from 0 (normal) to 85 (very severe).
Measured: baseline and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Graham A. Glass, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773253
- Sponsor's protocol ID
- Allergan cervical dystonia
- Status last verified
- Mar 2020
- First submitted
- 14 Oct 2008
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-injection, Multi-channel EMG Mapping to Optimize Botulinum Toxin Type A Efficacy in Cervical Dystonia.
- ClinicalTrials.gov ID
- NCT00773253
- Acronym / sponsor ID
- Allergan cervical dystonia
- Conditions
- Cervical Dystonia
- Keywords
- dystonia, cervical dystonia, Botox, idiopathic primary cervical dystonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Apr 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Posted 13 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how to improve treatment of patients with cervical dystonia who have not been helped with standard Botox injections. This study is for patients with cervical dystonia who have not benefited from treatment with Botox using conventional "single lead electromyographic (EMG) techniques" for injection. The study aim is to see if these patients may have significantly more benefit if their Botox is injected into muscles that have been chosen with a multi-channel EMG mapping study of the neck prior to Botox injection.
Detailed description
The most common type of primary late-onset dystonia is cervical dystonia. Botulinum toxin A (BTX-A) injections are a safe and effective treatment for cervical dystonia in a majority of patients, however, a significant minority of patients (between 15 and 25%) have a suboptimal response to Botulinum toxin therapy. It is unclear why some patients do not respond maximally to neurotoxin therapy.
Studies using needle electromyographic "mapping" in the evaluation of cervical dystonia have revealed that clinical examination alone is insufficient for determining which muscles contribute to the dystonic movement. When compared to needle electromyography (EMG) "mapping studies", experienced movement disorders specialists correctly identify only 59% of active muscles and believe that 25% of muscles which upon EMG evaluation are found to be quiescent, are involved in the dystonia. The selection of incorrect muscles for injection of Botulinum toxin may explain why some patients have a sub-optimal response.
This study seeks to measure outcomes when the muscles involved in dystonia are identified using "mapping" via an 8-12 channel EMG. In the proposed study, the most involved/active dystonic muscles will be correctly identified through simultaneous 8-12 channel mapping resulting in a more informed injection strategy, which may improve response to Botulinum toxin A treatment as compared to single lead EMG based injections. This study changes routine clinical care only by adding the step of studying the muscles of the neck with simultaneous EMG mapping to allow a more objective injection strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard EMG-guided Botox injection | Active comparator | Drug: Botulinum toxin AAll patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm. |
| Multi-channel EMG-guided Botox injection | Experimental | Drug: Botulinum toxin APatients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects, 18 to 75 years of age.
- Ability to follow study instructions and complete all required visits.
- Subject meets diagnostic criteria for idiopathic primary cervical dystonia.
- Subject has at least moderate severity Cervical Dystonia, with a baseline rating of at least 30 on the total TWSTRS and at least 15 on the TWSTRS motor severity subsection.
- Patients have had a suboptimal response to 2 previous Botulinum toxin injections at an outside facility.
Key exclusion criteria (6 listed)
- Known allergy or sensitivity to any of the components in BTX-A.
- Uncontrolled clinically significant medical condition other than the condition under evaluation
- Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Participation in another medication or device study or within 3 months of enrollment in this study.
- Patients know to have a positive frontalis test or have previously tested positive for the presence of BTX-A antibodies will be excluded.
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 AAlso: BotoxAll patients will be treated with Botox using both single-channel and multi-channel EMG mapping. | Drug | Multi-channel EMG-guided Botox injection, standard EMG-guided Botox injection |
Primary outcome
Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)
Time frame: pre-injection, week 16, 20, 36, and 40
Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale
Time frame: baseline and 48 weeks
Mean Percentage change in Toronto Western Spasmodic Torticollis Rating Scale. This scale ranges from 0 (normal) to 85 (very severe).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Not yet recruitingObservational study
Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
Torticollis (Arthrogenic)
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Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
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An Observational Study of Individuals With Isolated Dystonia
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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.
Graham A. Glass, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin A in people with Cervical Dystonia, run by University of California, San Francisco at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 23 Mar 2020. 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 United States. 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.
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?
Yes. Results are posted in the registry (first posted 13 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS) (time frame: pre-injection, week 16, 20, 36, and 40). The study lists 2 primary outcomes in all. 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 23 Mar 2020.