Cervical DystoniaNCT05103202
Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
An observational study of Cervical Dystonia and Blepharospasm, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Our hypothesis is that botulinum toxin injections (with onabotulinum toxin, incobotulinum toxin, and abobotulinum toxin) given at 10-week or shorter intervals for the indication of treatment of muscle spasms associated with neurological disorders are associated with equal safety and effectiveness as those given at… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Dystonia, Blepharospasm, Limb Dystonia
- Type of treatment
- Injection or infusion
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 14 Jun 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be recruited consecutively on presentation for treatment of muscle spasm due to neurological disease with botulinum toxin to the UT Southwestern Movement Disorders clinic by one of the investigators.
Who may be able to join
- Aim 1:
- Patient provides responses to an internet based survey which includes consent to participate
- Patient has been diagnosed with one or more of the conditions for which a HRQoL scale exists and will be employed in this study
- Patient has received at least 2 prior injections with botulinum toxin for that condition by one of the study investigators
- Both of the two most recent intervals between injections are either a) 10-weeks or less or b) 12-weeks or more
- Aim 2:
Show all 12Show fewer
- Patient provides responses to an internet based survey which includes consent to participate
- Patient has been diagnosed with one or more of the conditions for which a HRQoL scale exists and will be employed in this study
- Patient has received at least 2 prior injections with botulinum toxin for that condition by one of the study investigators
- Both of the two most recent intervals between injections are either a) 10-weeks or less or b) 12-weeks or more
- If receiving injections at 12-weeks or more, notes must have previously indicated that patient needs an injection interval of 10-weeks or less
- If receiving injections at 12-weeks or more, the reason must be that the insurance carrier covering that patient's medical costs refused to allow a 10-week or less injection frequency
Who cannot join
- For both Aims 1 and 2:
- Patient is unwilling to consent to study procedures (refuses to fill out surveys)
- Patient has variable injection frequencies such that the two most recent injections do not both meet criteria of being 10-weeks or less in frequency or 12-weeks or more in frequency
- Patient has a diagnosis of and is being treated for a condition for which a HRQoL scale does not exist
- Patient has insufficient chart documentation to characterize demographics, diagnosis, toxin selected, dose used, and injection frequency employed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin for the Treatment of Muscle Spasm Associated With Neurological Disorders
Our hypothesis is that botulinum toxin injections (with onabotulinum toxin, incobotulinum toxin, and abobotulinum toxin) given at 10-week or shorter intervals for the indication of treatment of muscle spasms associated with neurological disorders are associated with equal safety and effectiveness as those given at 12-week or longer intervals. We also hypothesize that for those patients who would prefer a shorter inter-injection interval, but for whom their insurance carrier has prevented this, have worse health-related quality of life compared to patients who receive injections at a 10-week or shorter interval. We aim to investigate this hypothesis by collecting demographic and injection data and patient survey responses.
Read the detailed description
Our project has the following aims:
Aim 1: to determine if any difference exists in safety or efficacy between patients receiving injections of botulinum toxin at 10-week or shorter intervals as compared to patients receiving injections at 12-week or longer intervals.
Aim 2: to determine if patients who have expressed a preference for injections at 10 week or shorter intervals but whose insurance carriers have mandated a 12-week interval have worse health related quality of life as compared to patients who are receiving injections at 10-week or shorter intervals.
This project consists of two analyses, each designed to accomplish aims 1 and 2. For both aims, we will invite consecutive patients who meet entry criteria to participate who are followed in the botulinum toxin injection clinics of the University of Texas Southwestern Medical Center movement disorders faculty. Participants who consent to data collection by participating in an email-administered survey of quality of life will have their medical records reviewed by an investigator for abstraction of clinical data (to include dose, injection site, injection interval, side effects, demographics, and diagnoses). Additionally, patients will fill out two or more survey instruments on the date of their enrollment visit following their botulinum toxin injection visit. The survey instruments completed will be 1) the SF-36 health questionnaire and 2) a disease-specific HRQoL survey chosen to be applicable to the specific condition for which that subject is receiving botulinum toxin injections. Patients receiving injections for multiple conditions will receive surveys for each condition for which they are receiving treatment. The disease specific scales to be used selectively depending on the patient's specific condition include:
- Blepharospasm disability index
- Craniocervical dystonia questionnaire (CDQ-24)
- Arm dystonia disability scale (ADDS)
- Hemifacial spasm scale (HSF-7)
- Oromandibular dystonia questionnaire (OMDQ-25)
- Spasticity scale (SQoL-6D)
For analysis, patients will be segregated into two groups (10-week or shorter inter-injection interval and 12 week or longer inter-injection interval) on the basis of time elapsed between the most recent botulinum toxin treatments. Clinical and survey data will be analyzed to determine if differences exist between the two groups.
- Conditions
- Cervical Dystonia, Blepharospasm, Limb Dystonia, Hemifacial Spasm, Spasticity, Muscle, Fragments of Torsion Dystonia
- Medical subject headings
- Torticollis, Blepharospasm, Dystonia, Hemifacial Spasm, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 10 weeks or less | Patients receiving botulinum toxin injections at a frequency of 10 weeks or less | |
| 12 weeks or more | Patients receiving botulinum toxin injections at a frequency of 12 weeks or more |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life measured by Short Form 36 (SF-36)
SF-36 HRQoL score as collected by a patient-completed survey (measured from 0 to 100 with a scoring system where 100 is best quality of life)
Measured: single measure at 1 day of enrollment
Safety of injection
Side effects recorded qualitatively and graded by severity (0 to 4 numerical subjective grade where 4 is most severe) by the injecting physician and attributed by that physician to the most recent injection
Measured: single measure at 1 day of enrollment
Secondary outcomes (6)
Blepharospasm disability index survey (BSDI)
Patient-completed survey BSDI- Disease specific quality of life score measured from 0 to 4 calculated as a mean of applicable items with 4 representing worst quality of life
Measured: single measure at 1 day of enrollment
Cervicocranial dystonia questionnaire (CDQ24)
Patient-completed survey CDQ24- Disease specific quality of life score measured from 0 to 100 with 100 representing worst quality of life
Measured: single measure at 1 day of enrollment
Arm Dystonia Disability Scale (ADDS)
Patient-completed survey ADDS- Disease specific quality of life score measured from 0 to 100% with 0% representing worst quality of life
Measured: single measure at 1 day of enrollment
Hemifacial Spasm Scale (HFS7)
Patient-completed survey HFS7- Disease specific quality of life score (measured from 0 to 4 where 4 is the most severe effect on quality of life)
Measured: single measure at 1 day of enrollment
Oromandibular dystonia questionnaire (OMDQ-25)
Patient-completed survey OMDQ-25- Disease specific quality of life score (measured from 0 to 100 with 100 representing worst quality of life)
Measured: single measure at 1 day of enrollment
Spasticity Quality of Life scale (SQoL-6D)
Patient-completed survey SQoL-6D- Disease specific quality of life score (measured from 0 to 100 with 100 representing best quality of life)
Measured: single measure at 1 day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start4 Nov 2021
- Primary completion7 Mar 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Dewey, University of Texas Southwestern Medical Center
- Investigators
- Richard B Dewey, Jr., MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103202
- Sponsor's protocol ID
- STU-2021-0224
- Status last verified
- Jun 2022
- First submitted
- 21 Oct 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simpson DM, Hallett M, Ashman EJ, Comella CL, Green MW, Gronseth GS, Armstrong MJ, Gloss D, Potrebic S, Jankovic J, Karp BP, Naumann M, So YT, Yablon SA. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache [RETIRED]: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016 May 10;86(19):1818-26. doi: 10.1212/WNL.0000000000002560. Epub 2016 Apr 18.
PubMed 27164716Tan EK, Fook-Chong S, Lum SY, Thumboo J. Validation of a short disease specific quality of life scale for hemifacial spasm: correlation with SF-36. J Neurol Neurosurg Psychiatry. 2005 Dec;76(12):1707-10. doi: 10.1136/jnnp.2005.065656.
PubMed 16291898Wissel J. Towards flexible and tailored botulinum neurotoxin dosing regimens for focal dystonia and spasticity - Insights from recent studies. Toxicon. 2018 Jun 1;147:100-106. doi: 10.1016/j.toxicon.2018.01.018. Epub 2018 Jan 31.
PubMed 29407165Truong DD, Gollomp SM, Jankovic J, LeWitt PA, Marx M, Hanschmann A, Fernandez HH; Xeomin US Blepharospasm Study Group. Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin((R))) injections in blepharospasm. J Neural Transm (Vienna). 2013 Sep;120(9):1345-53. doi: 10.1007/s00702-013-0998-9. Epub 2013 Feb 23.
PubMed 23435927Evidente VG, Truong D, Jankovic J, Comella CL, Grafe S, Hanschmann A. IncobotulinumtoxinA (Xeomin(R)) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci. 2014 Nov 15;346(1-2):116-20. doi: 10.1016/j.jns.2014.08.004. Epub 2014 Aug 10.
PubMed 25186131Greene P, Fahn S, Diamond B. Development of resistance to botulinum toxin type A in patients with torticollis. Mov Disord. 1994 Mar;9(2):213-7. doi: 10.1002/mds.870090216.
PubMed 8196686Jankovic J, Vuong KD, Ahsan J. Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology. 2003 Apr 8;60(7):1186-8. doi: 10.1212/01.wnl.0000055087.96356.bb.
PubMed 12682332Ruta D, Garratt A, Abdalla M, Buckingham K, Russell I. The SF 36 health survey questionnaire. A valid measure of health status.. BMJ. 1993 Aug 14;307(6901):448-9. doi: 10.1136/bmj.307.6901.448-b. No abstract available.
PubMed 8374477Jankovic J, Kenney C, Grafe S, Goertelmeyer R, Comes G. Relationship between various clinical outcome assessments in patients with blepharospasm. Mov Disord. 2009 Feb 15;24(3):407-13. doi: 10.1002/mds.22368.
PubMed 19053054Muller J, Wissel J, Kemmler G, Voller B, Bodner T, Schneider A, Wenning GK, Poewe W. Craniocervical dystonia questionnaire (CDQ-24): development and validation of a disease-specific quality of life instrument. J Neurol Neurosurg Psychiatry. 2004 May;75(5):749-53. doi: 10.1136/jnnp.2003.013441.
PubMed 15090572Peterson DA, Berque P, Jabusch HC, Altenmuller E, Frucht SJ. Rating scales for musician's dystonia: the state of the art. Neurology. 2013 Aug 6;81(6):589-98. doi: 10.1212/WNL.0b013e31829e6f72. Epub 2013 Jul 24.
PubMed 23884039Fahn, S., Assessment of the primary dystonias, in Quantification of Neurologic Deficit, M. TL, Editor. 1989, Butterworths: Oxford. p. 241-270.
Merz RI, Deakin J, Hawthorne MR. Oromandibular dystonia questionnaire (OMDQ-25): a valid and reliable instrument for measuring health-related quality of life. Clin Otolaryngol. 2010 Oct;35(5):390-6. doi: 10.1111/j.1749-4486.2010.02194.x.
PubMed 21108749Turner-Stokes L, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Fheodoroff K. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III). BMJ Open. 2016 Jun 17;6(6):e011157. doi: 10.1136/bmjopen-2016-011157.
PubMed 27315835
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin for the Treatment of Muscle Spasm Associated With Neurological Disorders
- ClinicalTrials.gov ID
- NCT05103202
- Acronym / sponsor ID
- STU-2021-0224
- Conditions
- Cervical Dystonia, Blepharospasm, Limb Dystonia, Hemifacial Spasm, Spasticity, Muscle, Fragments of Torsion Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 2 Nov 2021 (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.
Our hypothesis is that botulinum toxin injections (with onabotulinum toxin, incobotulinum toxin, and abobotulinum toxin) given at 10-week or shorter intervals for the indication of treatment of muscle spasms associated with neurological disorders are associated with equal safety and effectiveness as those given at 12-week or longer intervals. We also hypothesize that for those patients who would prefer a shorter inter-injection interval, but for whom their insurance carrier has prevented this, have worse health-related quality of life compared to patients who receive injections at a 10-week or shorter interval. We aim to investigate this hypothesis by collecting demographic and injection data and patient survey responses.
Detailed description
Our project has the following aims:
Aim 1: to determine if any difference exists in safety or efficacy between patients receiving injections of botulinum toxin at 10-week or shorter intervals as compared to patients receiving injections at 12-week or longer intervals.
Aim 2: to determine if patients who have expressed a preference for injections at 10 week or shorter intervals but whose insurance carriers have mandated a 12-week interval have worse health related quality of life as compared to patients who are receiving injections at 10-week or shorter intervals.
This project consists of two analyses, each designed to accomplish aims 1 and 2. For both aims, we will invite consecutive patients who meet entry criteria to participate who are followed in the botulinum toxin injection clinics of the University of Texas Southwestern Medical Center movement disorders faculty. Participants who consent to data collection by participating in an email-administered survey of quality of life will have their medical records reviewed by an investigator for abstraction of clinical data (to include dose, injection site, injection interval, side effects, demographics, and diagnoses). Additionally, patients will fill out two or more survey instruments on the date of their enrollment visit following their botulinum toxin injection visit. The survey instruments completed will be 1) the SF-36 health questionnaire and 2) a disease-specific HRQoL survey chosen to be applicable to the specific condition for which that subject is receiving botulinum toxin injections. Patients receiving injections for multiple conditions will receive surveys for each condition for which they are receiving treatment. The disease specific scales to be used selectively depending on the patient's specific condition include:
- Blepharospasm disability index
- Craniocervical dystonia questionnaire (CDQ-24)
- Arm dystonia disability scale (ADDS)
- Hemifacial spasm scale (HSF-7)
- Oromandibular dystonia questionnaire (OMDQ-25)
- Spasticity scale (SQoL-6D)
For analysis, patients will be segregated into two groups (10-week or shorter inter-injection interval and 12 week or longer inter-injection interval) on the basis of time elapsed between the most recent botulinum toxin treatments. Clinical and survey data will be analyzed to determine if differences exist between the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 weeks or less | – | –Patients receiving botulinum toxin injections at a frequency of 10 weeks or less |
| 12 weeks or more | – | –Patients receiving botulinum toxin injections at a frequency of 12 weeks or more |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited consecutively on presentation for treatment of muscle spasm due to neurological disease with botulinum toxin to the UT Southwestern Movement Disorders clinic by one of the investigators.
Key inclusion criteria (12 listed)
- Patient provides responses to an internet based survey which includes consent to participate
- Patient has been diagnosed with one or more of the conditions for which a HRQoL scale exists and will be employed in this study
- Patient has received at least 2 prior injections with botulinum toxin for that condition by one of the study investigators
- Both of the two most recent intervals between injections are either a) 10-weeks or less or b) 12-weeks or more
- Patient provides responses to an internet based survey which includes consent to participate
Key exclusion criteria (5 listed)
- Patient is unwilling to consent to study procedures (refuses to fill out surveys)
- Patient has variable injection frequencies such that the two most recent injections do not both meet criteria of being 10-weeks or less in frequency or 12-weeks or more in frequency
- Patient has a diagnosis of and is being treated for a condition for which a HRQoL scale does not exist
- Patient has insufficient chart documentation to characterize demographics, diagnosis, toxin selected, dose used, and injection frequency employed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life measured by Short Form 36 (SF-36)
Time frame: single measure at 1 day of enrollment
SF-36 HRQoL score as collected by a patient-completed survey (measured from 0 to 100 with a scoring system where 100 is best quality of life)
Safety of injection
Time frame: single measure at 1 day of enrollment
Side effects recorded qualitatively and graded by severity (0 to 4 numerical subjective grade where 4 is most severe) by the injecting physician and attributed by that physician to the most recent injection
6 secondary outcomes
Blepharospasm disability index survey (BSDI)
Time frame: single measure at 1 day of enrollment
Cervicocranial dystonia questionnaire (CDQ24)
Time frame: single measure at 1 day of enrollment
Arm Dystonia Disability Scale (ADDS)
Time frame: single measure at 1 day of enrollment
Hemifacial Spasm Scale (HFS7)
Time frame: single measure at 1 day of enrollment
Oromandibular dystonia questionnaire (OMDQ-25)
Time frame: single measure at 1 day of enrollment
Spasticity Quality of Life scale (SQoL-6D)
Time frame: single measure at 1 day of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 27164716Simpson DM, Hallett M, Ashman EJ, Comella CL, Green MW, Gronseth GS, Armstrong MJ, Gloss D, Potrebic S, Jankovic J, Karp BP, Naumann M, So YT, Yablon SA. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache [RETIRED]: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016 May 10;86(19):1818-26. doi: 10.1212/WNL.0000000000002560. Epub 2016 Apr 18.
- Background: PubMed 16291898Tan EK, Fook-Chong S, Lum SY, Thumboo J. Validation of a short disease specific quality of life scale for hemifacial spasm: correlation with SF-36. J Neurol Neurosurg Psychiatry. 2005 Dec;76(12):1707-10. doi: 10.1136/jnnp.2005.065656.
- Background: PubMed 29407165Wissel J. Towards flexible and tailored botulinum neurotoxin dosing regimens for focal dystonia and spasticity - Insights from recent studies. Toxicon. 2018 Jun 1;147:100-106. doi: 10.1016/j.toxicon.2018.01.018. Epub 2018 Jan 31.
- Background: PubMed 23435927Truong DD, Gollomp SM, Jankovic J, LeWitt PA, Marx M, Hanschmann A, Fernandez HH; Xeomin US Blepharospasm Study Group. Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin((R))) injections in blepharospasm. J Neural Transm (Vienna). 2013 Sep;120(9):1345-53. doi: 10.1007/s00702-013-0998-9. Epub 2013 Feb 23.
- Background: PubMed 25186131Evidente VG, Truong D, Jankovic J, Comella CL, Grafe S, Hanschmann A. IncobotulinumtoxinA (Xeomin(R)) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci. 2014 Nov 15;346(1-2):116-20. doi: 10.1016/j.jns.2014.08.004. Epub 2014 Aug 10.
- Background: PubMed 8196686Greene P, Fahn S, Diamond B. Development of resistance to botulinum toxin type A in patients with torticollis. Mov Disord. 1994 Mar;9(2):213-7. doi: 10.1002/mds.870090216.
- Background: PubMed 12682332Jankovic J, Vuong KD, Ahsan J. Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology. 2003 Apr 8;60(7):1186-8. doi: 10.1212/01.wnl.0000055087.96356.bb.
- Background: PubMed 8374477Ruta D, Garratt A, Abdalla M, Buckingham K, Russell I. The SF 36 health survey questionnaire. A valid measure of health status.. BMJ. 1993 Aug 14;307(6901):448-9. doi: 10.1136/bmj.307.6901.448-b. No abstract available.
- Background: PubMed 19053054Jankovic J, Kenney C, Grafe S, Goertelmeyer R, Comes G. Relationship between various clinical outcome assessments in patients with blepharospasm. Mov Disord. 2009 Feb 15;24(3):407-13. doi: 10.1002/mds.22368.
- Background: PubMed 15090572Muller J, Wissel J, Kemmler G, Voller B, Bodner T, Schneider A, Wenning GK, Poewe W. Craniocervical dystonia questionnaire (CDQ-24): development and validation of a disease-specific quality of life instrument. J Neurol Neurosurg Psychiatry. 2004 May;75(5):749-53. doi: 10.1136/jnnp.2003.013441.
- Background: PubMed 23884039Peterson DA, Berque P, Jabusch HC, Altenmuller E, Frucht SJ. Rating scales for musician's dystonia: the state of the art. Neurology. 2013 Aug 6;81(6):589-98. doi: 10.1212/WNL.0b013e31829e6f72. Epub 2013 Jul 24.
- BackgroundFahn, S., Assessment of the primary dystonias, in Quantification of Neurologic Deficit, M. TL, Editor. 1989, Butterworths: Oxford. p. 241-270.
- 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.
Richard B Dewey, Jr., MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dystonia and Blepharospasm, run by University of Texas Southwestern Medical Center 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 12 inclusion and 5 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 30 Jun 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Life measured by Short Form 36 (SF-36) (time frame: single measure at 1 day of enrollment). 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?
On the ClinicalTrials.gov record for NCT05103202, which also lists 14 linked publications.
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 30 Jun 2022.