BlepharospasmPhase 4NCT03508882
Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm
A Phase 4 study testing Botulinum Toxin Type A 100Unit/Vial (Product) and Saline Solution for Injection in people with Blepharospasm and Hemifacial Spasm, run by The University of Hong Kong.
Trial summary
A triple-masked placebo-controlled trial assessing the efficacy and safety of pretarsal versus preseptal botulinum toxin for patients with eyelid spasm. The investigators hypothesize injection of botulinum toxin into the pretarsal orbicularis oculi muscle will have greater clinical efficacy, better measured quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharospasm, Hemifacial Spasm, Botulinum Toxins, Type A
- What is being tested?
- Botulinum Toxin Type A 100Unit/Vial (Product) and Saline Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 20 Feb 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years-of-age
- Clinical diagnosis eyelid dystonia, consisting of either blepharospasm or hemifacial spasm
- Patient wish to have treatment with botulinum toxin type A (BtA).
Who cannot join
- Patients unable to express their symptoms or history to the extent that they are not able to complete the study questionnaires, such as those suffering from dementia.
- Existence of potential contraindications to BtA treatment:
- Pregnancy
- Breastfeeding
- Prior allergic reaction
- Active infection or inflammation in the treatment area
Show all 9Show fewer
- Neuromuscular and peripheral neuropathic disease
- Concomitant aminoglycoside therapy
- Patients with poor or unstable general health with activities of daily living severely affected by non-dystonia confounding factors, such as hospitalized or bed bound patients.
About this study
Official title: Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm: a Randomized, Triple-blind, Placebo-controlled, Cross-over Clinical Trial
A triple-masked placebo-controlled trial assessing the efficacy and safety of pretarsal versus preseptal botulinum toxin for patients with eyelid spasm. The investigators hypothesize injection of botulinum toxin into the pretarsal orbicularis oculi muscle will have greater clinical efficacy, better measured quality of life, fewer complications, and better cost effectiveness in comparison to a preseptal pattern of injection.
Read the detailed description
The study design is a prospective, randomized, triple-blinded placebo controlled crossover trial. A computer-generated list of random numbers will be used for allocation of patients. The patients, treating physicians, and outcome assessors will be masked to the contents of the Botulinum Toxin Type A (BtA) and placebo syringe injections. The placebo will consist of vehicle only, which is the same sterile normal 0.9% saline used in reconstitution of the BtA. At month 6, each group will crossover and receive the alternative intervention. The primary outcome measure (JRS severity) will be the change as measured 1 month after the second cycle of each intervention. Secondary outcome measures include the TWSTRS (clinical response), Blepharospasm Disability Index (BSDI), CDQ-24 (quality of life), VAS (pain), and GAS (global) scores and incidence of side effects. The investigators plan to compare the outcome measures between groups with linear mixed models allowing for the crossover design.
Data will be collected at each of the injection visits and at both of the clinical activity visits. The data will be processed by the research assistant and analysed by the project biostatistician. The investigators plan to compare the primary (JRS) and secondary outcome measures (TWSTRS, BSDI, CDQ-24, VAS, and GAS scores) between the Preseptal-pretarsal (Group 1) and the Pretarsal-preseptal (Group 2) allowing for the crossover design. Specifically, the investigators will use a 2-sample t-test to compare all values of the JRS in group 1 with all the values of the JRS in group 2. This will allow the investigators to determine whether carryover effects are present, and the investigators have specified a 3-month washout period between the first and second round of injections to minimise the chance of carryover effects. If carryover effects are present, the investigators will allow for these in further analysis. The investigators will then use linear mixed models to estimate the difference between the two interventions, allowing for the repeated measures, and if necessary for carryover effects. In secondary analyses, the investigators will evaluate the proportion of patients with relief of spasm, improvement in quality of life, and incidence of side effects, including eyelid ptosis measurements between the two interventions, using logistic regression. P values of 0.05 or less will be considered statistically significant. All analyses will be conducted under the principle of Intention to Treat, using multiple imputation to account for any missing data and to include all randomized patients in analysis.
- Conditions
- Blepharospasm, Hemifacial Spasm, Botulinum Toxins, Type A
- Being tested
- Botulinum Toxin Type A 100Unit/Vial (Product), Saline Solution for Injection
- Keywords
- Eyelid, Dystonia, Botulinum injection, Oculoplastics
- Medical subject headings
- Blepharospasm, Hemifacial Spasm, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A 100Unit/Vial (Product)Drug
Also called Botox
Botulinum Toxin Type A 100Unit/Vial (Product) comes as a dry powder and is routinely reconstituted with Saline Solution for Injection
Saline Solution for InjectionDrug
Also called Placebo
The placebo consists of vehicle only. Saline Solution for Injection is the vehicle substance normally used to reconstitute Botulinum Toxin Type A (see 1st Intervention above).
| Study group | Role | What they receive |
|---|---|---|
| Preseptal-pretarsal | Active comparator | The Preseptal-pretarsal group will receive injections of Botulinum Toxin Type A 100Unit/Vial (Product) in the preseptal site (Injection pattern A) and Saline Solution for Injection (placebo control) in the pretarsal site for 2 cycles at 3 months apart. Both groups will crossover and receive the alternative intervention. Hence in the second half of the trial, the Preseptal-pretarsal group will be injected with BtA in Pattern B and Pretarsal-preseptal group will receive Pattern A. Receives: Drug: Botulinum Toxin Type A 100Unit/Vial (Product); Drug: Saline Solution for Injection |
| Pretarsal-preseptal | Active comparator | The Pretarsal-preseptal group will initially receive injections Botulinum Toxin Type A 100Unit/Vial (Product) in the reverse with the intervention at the pretarsal site (Injection pattern B) for 2 cycles at 3 months apart. Groups 1 and 2 will crossover and receive the alternative intervention. Both groups will crossover and receive the alternative intervention. Hence in the second half of the trial, the Preseptal-pretarsal group will be injected with BtA in Pattern B and Pretarsal-preseptal group will receive Pattern A. Receives: Drug: Botulinum Toxin Type A 100Unit/Vial (Product); Drug: Saline Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jankovic Rating Scale (JRS)
The severity of the patient's spasm employing the widely used JRS scale. The JRS is scored between 0 and 4 (0 = no spasm, 1 = mild, barely noticeable, 2 = mild, without functional impairment, 3 = moderate spasm, moderate functional impairment, 4 = severe incapacitating spasm). The JRS will be scored independently by two graders from a video clip of approximately 30-60 seconds in duration. Differences between the 2 scores will be arbitrated by a third reviewer.
Measured: The videos will be taken at the clinical activity visits (C1 and C2) will be scheduled for months 4 and 10. The primary outcome measure will consist of the change from C1 to C2.
Secondary outcomes (6)
Toronto (TWSTRS)
TWSTRS instrument measuring clinical response. Scored between -1 and 5 (-1 = worse, 0 = no benefit, 1 = minimal or equivocal reduction in spasm, 2 = mild response with some reduction in spasm, 3 = moderate response with some reduction in spasm, 4 = marked reduction of spasm but spasm still present, 5 = major improvement with little or no residual spasm). The change between the 2 clinical activity visits (C1-C2) will be assessed.
Measured: C1 and C2 will take place at months 4 and 10.
Blepharospasm Disability Index (BSDI)
Measure of disability. The change between the 2 clinical activity visits (C1-C2) will be assessed.
Measured: C1 and C2 will take place at months 4 and 10.
Craniocervical Dystonia Questionnaire (CDQ-24)
Measure of quality of life. The change between the 2 clinical activity visits (C1-C2) will be assessed.
Measured: C1 and C2 will take place at months 4 and 10.
Global Assessment Scale (GAS)
To assess the overall status of the patient's disease. The GAS is determined by asking the patient the percentage of function the patient is experiencing. The analogue instrument ranges from "Free of complaints" on the left side to "Suffering extremely" on the right side of a line. Patients self-rate by marking where on the line best represents their current condition. The line measures 100 millimeters long. The mark is measured and the value recorded, ranging from 0 (Free of complaints) to 100 (Suffering extremely). Thus a lower value represents a better outcome.
The change between the 2 clinical activity visits (C1-C2) will be assessed.
Measured: C1 and C2 will take place at months 4 and 10.
Visual analogue scale (VAS) for pain
VAS (range 0-10, no pain = 0, unbearable pain = 0) will be used to assess. The change between the 2 clinical activity visits (C1-C2) will be assessed.
patients' perception of pain for each of the 2 injections patterns
Measured: Measured at each injection visit (months 0, 3, 6, and 9).
Ptosis monitoring
Specifically, cropped photographs of both eyelids will be analysed using ImageJ (National Institutes of Health, USA). The Margin-Reflex-Distance 1 (MRD1) measurements will be calculated using the ImageJ software's line tool to capture the height of the upper eyelid and evaluate and quantify the development of any ptosis complications. The change between the 2 clinical activity visits (C1-C2) will be assessed.
Measured: C1 and C2 will take place at months 4 and 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Jul 2015
- Primary completion31 Oct 2017
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for BlepharospasmStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Marcus M. Marcet, MD, The University of Hong Kong
- Investigators
- Marcus M Marcet, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508882
- Sponsor's protocol ID
- HMRF Project No.: 12133171
- Other IDs
- Protocol : MMBT; v1.3;1Mar16
- Status last verified
- Apr 2019
- First submitted
- 18 Mar 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jankovic J. Blepharospasm with basal ganglia lesions. Arch Neurol. 1986 Sep;43(9):866-8. doi: 10.1001/archneur.1986.00520090006004. No abstract available.
PubMed 3741202Dutton JJ, Fowler AM. Botulinum toxin in ophthalmology. Surv Ophthalmol. 2007 Jan-Feb;52(1):13-31. doi: 10.1016/j.survophthal.2006.10.003.
PubMed 17212988Czyz CN, Burns JA, Petrie TP, Watkins JR, Cahill KV, Foster JA. Long-term botulinum toxin treatment of benign essential blepharospasm, hemifacial spasm, and Meige syndrome. Am J Ophthalmol. 2013 Jul;156(1):173-177.e2. doi: 10.1016/j.ajo.2013.02.001. Epub 2013 Mar 28.
PubMed 23541393Harrison AR, Erickson JP, Anderson JS, Lee MS. Pain relief in patients receiving periocular botulinum toxin A. Ophthalmic Plast Reconstr Surg. 2008 Mar-Apr;24(2):113-6. doi: 10.1097/IOP.0b013e31816386e1.
PubMed 18356715Hilker R, Schischniaschvili M, Ghaemi M, Jacobs A, Rudolf J. Health related quality of life is improved by botulinum neurotoxin type A in long term treated patients with focal dystonia. J Neurol Neurosurg Psychiatry. 2001 Aug;71(2):193-9. doi: 10.1136/jnnp.71.2.193.
PubMed 11459891Muller 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 15090572Hall TA, McGwin G Jr, Searcey K, Xie A, Hupp SL, Owsley C, Kline LB. Health-related quality of life and psychosocial characteristics of patients with benign essential blepharospasm. Arch Ophthalmol. 2006 Jan;124(1):116-9. doi: 10.1001/archopht.124.1.116.
PubMed 16401794Jankovic J, Schwartz K, Donovan DT. Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):633-9. doi: 10.1136/jnnp.53.8.633.
PubMed 2213039Thenganatt MA, Fahn S. Botulinum toxin for the treatment of movement disorders. Curr Neurol Neurosci Rep. 2012 Aug;12(4):399-409. doi: 10.1007/s11910-012-0286-3.
PubMed 22661378Huang W, Foster JA, Rogachefsky AS. Pharmacology of botulinum toxin. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):249-59. doi: 10.1067/mjd.2000.105567.
PubMed 10906647Harrison AR. Chemodenervation for facial dystonias and wrinkles. Curr Opin Ophthalmol. 2003 Oct;14(5):241-5. doi: 10.1097/00055735-200310000-00003.
PubMed 14502050Costa J, Espirito-Santo C, Borges A, Ferreira JJ, Coelho M, Moore P, Sampaio C. Botulinum toxin type A therapy for blepharospasm. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD004900. doi: 10.1002/14651858.CD004900.pub2.
PubMed 15674969Aramideh M, Ongerboer de Visser BW, Brans JW, Koelman JH, Speelman JD. Pretarsal application of botulinum toxin for treatment of blepharospasm. J Neurol Neurosurg Psychiatry. 1995 Sep;59(3):309-11. doi: 10.1136/jnnp.59.3.309.
PubMed 7673963Jankovic J. Pretarsal injection of botulinum toxin for blepharospasm and apraxia of eyelid opening. J Neurol Neurosurg Psychiatry. 1996 Jun;60(6):704. doi: 10.1136/jnnp.60.6.704. No abstract available.
PubMed 8648354Albanese A, Bentivoglio AR, Colosimo C, Galardi G, Maderna L, Tonali P. Pretarsal injections of botulinum toxin improve blepharospasm in previously unresponsive patients. J Neurol Neurosurg Psychiatry. 1996 Jun;60(6):693-4. doi: 10.1136/jnnp.60.6.693-a. No abstract available.
PubMed 8648343
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm: a Randomized, Triple-blind, Placebo-controlled, Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT03508882
- Acronym / sponsor ID
- HMRF Project No.: 12133171
- Conditions
- Blepharospasm, Hemifacial Spasm, Botulinum Toxins, Type A
- Keywords
- Eyelid, Dystonia, Botulinum injection, Oculoplastics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 26 Apr 2018 (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.
A triple-masked placebo-controlled trial assessing the efficacy and safety of pretarsal versus preseptal botulinum toxin for patients with eyelid spasm. The investigators hypothesize injection of botulinum toxin into the pretarsal orbicularis oculi muscle will have greater clinical efficacy, better measured quality of life, fewer complications, and better cost effectiveness in comparison to a preseptal pattern of injection.
Detailed description
The study design is a prospective, randomized, triple-blinded placebo controlled crossover trial. A computer-generated list of random numbers will be used for allocation of patients. The patients, treating physicians, and outcome assessors will be masked to the contents of the Botulinum Toxin Type A (BtA) and placebo syringe injections. The placebo will consist of vehicle only, which is the same sterile normal 0.9% saline used in reconstitution of the BtA. At month 6, each group will crossover and receive the alternative intervention. The primary outcome measure (JRS severity) will be the change as measured 1 month after the second cycle of each intervention. Secondary outcome measures include the TWSTRS (clinical response), Blepharospasm Disability Index (BSDI), CDQ-24 (quality of life), VAS (pain), and GAS (global) scores and incidence of side effects. The investigators plan to compare the outcome measures between groups with linear mixed models allowing for the crossover design.
Data will be collected at each of the injection visits and at both of the clinical activity visits. The data will be processed by the research assistant and analysed by the project biostatistician. The investigators plan to compare the primary (JRS) and secondary outcome measures (TWSTRS, BSDI, CDQ-24, VAS, and GAS scores) between the Preseptal-pretarsal (Group 1) and the Pretarsal-preseptal (Group 2) allowing for the crossover design. Specifically, the investigators will use a 2-sample t-test to compare all values of the JRS in group 1 with all the values of the JRS in group 2. This will allow the investigators to determine whether carryover effects are present, and the investigators have specified a 3-month washout period between the first and second round of injections to minimise the chance of carryover effects. If carryover effects are present, the investigators will allow for these in further analysis. The investigators will then use linear mixed models to estimate the difference between the two interventions, allowing for the repeated measures, and if necessary for carryover effects. In secondary analyses, the investigators will evaluate the proportion of patients with relief of spasm, improvement in quality of life, and incidence of side effects, including eyelid ptosis measurements between the two interventions, using logistic regression. P values of 0.05 or less will be considered statistically significant. All analyses will be conducted under the principle of Intention to Treat, using multiple imputation to account for any missing data and to include all randomized patients in analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preseptal-pretarsal | Active comparator | Drug: Botulinum Toxin Type A 100Unit/Vial (Product), Drug: Saline Solution for InjectionThe Preseptal-pretarsal group will receive injections of Botulinum Toxin Type A 100Unit/Vial (Product) in the preseptal site (Injection pattern A) and Saline Solution for Injection (placebo control) in the pretarsal site for 2 cycles at 3 months apart. Both groups will crossover and receive the alternative intervention. Hence in the second half of the trial, the Preseptal-pretarsal group will be injected with BtA in Pattern B and Pretarsal-preseptal group will receive Pattern A. |
| Pretarsal-preseptal | Active comparator | Drug: Botulinum Toxin Type A 100Unit/Vial (Product), Drug: Saline Solution for InjectionThe Pretarsal-preseptal group will initially receive injections Botulinum Toxin Type A 100Unit/Vial (Product) in the reverse with the intervention at the pretarsal site (Injection pattern B) for 2 cycles at 3 months apart. Groups 1 and 2 will crossover and receive the alternative intervention. Both groups will crossover and receive the alternative intervention. Hence in the second half of the trial, the Preseptal-pretarsal group will be injected with BtA in Pattern B and Pretarsal-preseptal group will receive Pattern A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years-of-age
- Clinical diagnosis eyelid dystonia, consisting of either blepharospasm or hemifacial spasm
- Patient wish to have treatment with botulinum toxin type A (BtA).
Key exclusion criteria (9 listed)
- Patients unable to express their symptoms or history to the extent that they are not able to complete the study questionnaires, such as those suffering from dementia.
- Existence of potential contraindications to BtA treatment:
- Patients with poor or unstable general health with activities of daily living severely affected by non-dystonia confounding factors, such as hospitalized or bed bound patients.
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 100Unit/Vial (Product)Also: BotoxBotulinum Toxin Type A 100Unit/Vial (Product) comes as a dry powder and is routinely reconstituted with Saline Solution for Injection | Drug | Preseptal-pretarsal, Pretarsal-preseptal |
| Saline Solution for InjectionAlso: PlaceboThe placebo consists of vehicle only. Saline Solution for Injection is the vehicle substance normally used to reconstitute Botulinum Toxin Type A (see 1st Intervention above). | Drug | Preseptal-pretarsal, Pretarsal-preseptal |
Primary outcome
Jankovic Rating Scale (JRS)
Time frame: The videos will be taken at the clinical activity visits (C1 and C2) will be scheduled for months 4 and 10. The primary outcome measure will consist of the change from C1 to C2.
The severity of the patient's spasm employing the widely used JRS scale. The JRS is scored between 0 and 4 (0 = no spasm, 1 = mild, barely noticeable, 2 = mild, without functional impairment, 3 = moderate spasm, moderate functional impairment, 4 = severe incapacitating spasm). The JRS will be scored independently by two graders from a video clip of approximately 30-60 seconds in duration. Differences between the 2 scores will be arbitrated by a third reviewer.
6 secondary outcomes
Toronto (TWSTRS)
Time frame: C1 and C2 will take place at months 4 and 10.
Blepharospasm Disability Index (BSDI)
Time frame: C1 and C2 will take place at months 4 and 10.
Craniocervical Dystonia Questionnaire (CDQ-24)
Time frame: C1 and C2 will take place at months 4 and 10.
Global Assessment Scale (GAS)
Time frame: C1 and C2 will take place at months 4 and 10.
Visual analogue scale (VAS) for pain
Time frame: Measured at each injection visit (months 0, 3, 6, and 9).
Ptosis monitoring
Time frame: C1 and C2 will take place at months 4 and 10.
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 26 Apr 2019.
- Background: PubMed 3741202Jankovic J. Blepharospasm with basal ganglia lesions. Arch Neurol. 1986 Sep;43(9):866-8. doi: 10.1001/archneur.1986.00520090006004. No abstract available.
- Background: PubMed 17212988Dutton JJ, Fowler AM. Botulinum toxin in ophthalmology. Surv Ophthalmol. 2007 Jan-Feb;52(1):13-31. doi: 10.1016/j.survophthal.2006.10.003.
- Background: PubMed 23541393Czyz CN, Burns JA, Petrie TP, Watkins JR, Cahill KV, Foster JA. Long-term botulinum toxin treatment of benign essential blepharospasm, hemifacial spasm, and Meige syndrome. Am J Ophthalmol. 2013 Jul;156(1):173-177.e2. doi: 10.1016/j.ajo.2013.02.001. Epub 2013 Mar 28.
- Background: PubMed 18356715Harrison AR, Erickson JP, Anderson JS, Lee MS. Pain relief in patients receiving periocular botulinum toxin A. Ophthalmic Plast Reconstr Surg. 2008 Mar-Apr;24(2):113-6. doi: 10.1097/IOP.0b013e31816386e1.
- Background: PubMed 11459891Hilker R, Schischniaschvili M, Ghaemi M, Jacobs A, Rudolf J. Health related quality of life is improved by botulinum neurotoxin type A in long term treated patients with focal dystonia. J Neurol Neurosurg Psychiatry. 2001 Aug;71(2):193-9. doi: 10.1136/jnnp.71.2.193.
- 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 16401794Hall TA, McGwin G Jr, Searcey K, Xie A, Hupp SL, Owsley C, Kline LB. Health-related quality of life and psychosocial characteristics of patients with benign essential blepharospasm. Arch Ophthalmol. 2006 Jan;124(1):116-9. doi: 10.1001/archopht.124.1.116.
- Background: PubMed 2213039Jankovic J, Schwartz K, Donovan DT. Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):633-9. doi: 10.1136/jnnp.53.8.633.
- Background: PubMed 22661378Thenganatt MA, Fahn S. Botulinum toxin for the treatment of movement disorders. Curr Neurol Neurosci Rep. 2012 Aug;12(4):399-409. doi: 10.1007/s11910-012-0286-3.
- Background: PubMed 10906647Huang W, Foster JA, Rogachefsky AS. Pharmacology of botulinum toxin. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):249-59. doi: 10.1067/mjd.2000.105567.
- Background: PubMed 14502050Harrison AR. Chemodenervation for facial dystonias and wrinkles. Curr Opin Ophthalmol. 2003 Oct;14(5):241-5. doi: 10.1097/00055735-200310000-00003.
- Background: PubMed 15674969Costa J, Espirito-Santo C, Borges A, Ferreira JJ, Coelho M, Moore P, Sampaio C. Botulinum toxin type A therapy for blepharospasm. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD004900. doi: 10.1002/14651858.CD004900.pub2.
- General information about eyelid spasms and treatmentLink provided by the sponsor.
- 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.
Marcus M Marcet, MD principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A 100Unit/Vial (Product) and Saline Solution for Injection in people with Blepharospasm and Hemifacial Spasm, run by The University of Hong Kong.
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: finished, as of the sponsor's last update on 26 Apr 2019. 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?
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?
Jankovic Rating Scale (JRS) (time frame: The videos will be taken at the clinical activity visits (C1 and C2) will be scheduled for months 4 and 10. The primary outcome measure will consist of the change from C1 to C2.). 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 NCT03508882, which also lists 23 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 26 Apr 2019.