Comparing the efficacy of Toxin Botulinum type A with commercial names, MASPORT and DYSPORT in Benign Essential Blepharospasm: a Double blind Randomized Clinical Trial
Comparing the efficacy of Toxin Botulinum type A with commercial names, MASPORT and DYSPORT in Benign Essential Blepharospasm (BEB)
Design
Randomized, double-blind, parallel-group trials, 19 samples in each group, 4. permuted block is the method of randomization.
Settings and conduct
Study Place: Labafi Nezhad Hospital in Tehran. Intervention: the "MASPORT" or "DYSPORT" group receives the same dose of medication. Before the injections and during follow-up examinations, the severity of spasms and daily functional visual impairment will be recorded. All mentioned examinations will be performed in follow-up visits after the injections. To maintain the double-blind nature of the study, the randomization and preparation of the drugs for injection will be performed by an operating room nurse. After covering the drug vial, it will be handed over to the injector. Additionally, the examiner and patients will not be informed about the type of injected medication during the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: individuals over 18 years old, clinically diagnosed with BEB, without prior BTX-A injection in the previous 6 months, and a history of previous eyelid surgery. Exclusion criteria included disorders of the neuromuscular junction, pregnancy or lactation, secondary causes of Blepharospasm, and prescription of medications affecting neuromuscular junction transmission
Intervention groups
Group1: Botulinom Toxin A injection with the trade name MASPORT.
Group2: Botulinom Toxin A injection with the trade name DYSPORT
Main outcome variables
Advancements in the severity and frequency grades of spasms, and Functional Visual Status(FVS)
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20240216061023N1
Registration date:2024-05-17, 1403/02/28
Registration timing:registered_while_recruiting
Last update:2024-05-17, 1403/02/28
Update count:0
Registration date
2024-05-17, 1403/02/28
Registrant information
Name
Nazanin Behnaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2270 7887
Email address
n.behnaz1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-25, 1402/12/06
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of Toxin Botulinum type A with commercial names, MASPORT and DYSPORT in Benign Essential Blepharospasm: a Double blind Randomized Clinical Trial
Public title
Efficacy of MASPORT in Blepharospasm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinically diagnosed with BEB
Without prior BTX-A injection in the previous 6 month
History of previous eyelid surgery
Exclusion criteria:
pregnancy or lactation
secondary causes of Blepharospasm
History of disorders of the neuromuscular junction like myasthenia gravis, Eaton-Lambert Syndrome, and psychological instability
prescription of antispastic, muscle relaxants or medications affecting neuromuscular junction transmission such as aminoglycosides
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
19
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: Permuted block randomization
Unit of randomization: Individual
Randomization Tools: using a computer program and a permuted block technique with blocks of length ,4.
Blinding (investigator's opinion)
Double blinded
Blinding description
A double-blind methodology was strictly enforced, wherein the participants and the entire cadre of investigators involved in the study, including the administering Ophthalmologists and outcome assessors remained uninformed about the treatment assignments.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ophthalmic and vision research center, Shahid Beheshti University of Medical Sci
Street address
No. 23, 9th boostan, Paydarfar Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1666673111
Approval date
2023-10-08, 1402/07/16
Ethics committee reference number
IR.SBMU.ORC.REC.1402.019
Health conditions studied
1
Description of health condition studied
Benign Essential Blepharospasm (BEB)
ICD-10 code
G24.5
ICD-10 code description
Blepharospasm
Primary outcomes
1
Description
Advance in the severity and frequency grades of spasms (more than at least one grade improvement in severity score
Timepoint
Four weeks post-injection phase
Method of measurement
Based on Severity and Frequency Spasm Score
Secondary outcomes
1
Description
Change in Functional Visual Status (FVS)
Timepoint
4, 8, 12 and 16 weeks post-injection
Method of measurement
Functional Visual Status based on the Jankovic Rating Scale (JRS) and functional visual status (FVS) grading table
2
Description
Onset of response (denoting the period between the injection and the initial indication of improvement following treatment)
Timepoint
4, 8, 12 and 16 weeks post-injection
Method of measurement
The time that the patient states that the symptoms of recovery have appeared.
3
Description
The duration of effect (representing the time lapse between the first noticeable clinical impact and the point at which the patient sensed the necessity for further treatment and improvement from the patient perspective)
Timepoint
4, 8, 12 and 16 weeks post-injection
Method of measurement
The period of time fom injection to the time that patient claim to observe improvement symptoms
4
Description
Need for retreatment (the point at which the ophthalmologist diagnosed that the patient needs for retreatment)
Timepoint
4, 8, 12 and 16 weeks post-injection
Method of measurement
The period of time fom injection to the time that ophthalmologist consider reinjection for the patient.
5
Description
Blepharospasm severity improvement (equal and more than one grade)
Timepoint
4, 8, 12 and 16 weeks post-injection
Method of measurement
Based on the Severity of spasm grading table , Jankovic Rating Scale (JRS)
6
Description
Blepharospasm frequency improvement ( equal and more than one grade)
Timepoint
4, 8, 12 and 16 weeks post-injection
Method of measurement
Based on the Frequency of spasm grading table , Jankovic Rating Scale (JRS)
Intervention groups
1
Description
Injection of Iranian product of Botulinom Toxin A with commercial name, MASPORT.[masoondarou.com] it contains 500 units of botulinum toxin A that is diluted by 3.2 CC sodium chloride 0.9% solution. the solution is preserved at a temperature of 2-8 degrees C. The injection will be done by a 30 gauge needle in the selected area for benign essential blepharospasm.[Smith and Nesi’s Ophthalmic Plastic and Reconstructive Surgery].total dosage for every person is 100-120 units of toxin based on clinical opthalmologist judgment, that is in the therapeutic dosage range for blepharospasm. follow up period is 16 weeks after injection.
Category
Treatment - Drugs
2
Description
Injection of FDA approved product of Botulinom Toxin A with commercial name, DYSPORT[Ipsen, UK]. it contains 500 units of botulinum toxin A that is diluted by 3.2 CC sodium chloride 0.9% solution. the solution is preserved at a temperature of 2-8 degrees C. The injection will be done by a 30 gauge needle in the selected area for benign essential blepharospasm.[Smith and Nesi’s Ophthalmic Plastic and Reconstructive Surgery].total dosage for every person is 100-120 units of toxin based on clinical opthalmologist judgment that is in the therapeutic dosage range for blepharospasm. follow up period is 16 weeks after injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad Medical Center
Full name of responsible person
Amirreza Veisi
Street address
Labbafinejad Medical Center, 9th Boostan Alley, Paydarfar Ave, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
۱۶۶۶۶۶۳۱۱۱
Phone
+98 21 2256 2138
Fax
Email
Nazanin.behnaz@sbmu.ac.ir
Web page address
https://lamc.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirreza Veisi
Street address
Labbafinejad Medical Center, Pasdaran Ave, Paydarfar Ave, 9th Boostan Alley
City
Tehran
Province
Tehran
Postal code
166663111
Phone
+98 21 23601
Email
Nazanin.behnaz@sbmu.ac.ir
Web page address
https://lamc.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Behnaz
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Labbafinajd Medical Center, 9th boostan Alley, Paydarfar Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
166663111
Phone
+98 21 2256 2138
Email
n.behnaz1990@gmail.com
Web page address
https://sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirreza Veisi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
labbafinejad Medical Center, 9th Bootan Alley, Paydarfar Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
166663111
Phone
+98 21 2256 2138
Email
amirveisi3@gmail.com
Web page address
https://sbmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Behnaz
Position
Assistant Professsor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Labbafinajd Medical Center, 9th Boostan Alley, Paydarfar Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
166663111
Phone
+98 21 2256 2138
Email
n.behnaz1990@gmail.com
Web page address
https://sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the data/document files will be shared if necessary after eliminating the patient's name.
When the data will become available and for how long
These documents/data files will become available after publishing the article.
To whom data/document is available
The data will be available for all interested individuals and groups
Under which criteria data/document could be used
Using the data for analysis is just allowed with author's permission and under her supervision
From where data/document is obtainable
1-n.behnaz1990@gmail.com
2-amirveisi3@gmail.com
What processes are involved for a request to access data/document
Data sharing will be conducted based on the author's recognition after interaction via Email.