Determining the effect of botulinum toxin A in patients with treatment-resistant migraine and tension headaches in individuals aged 20 to 70 years
Design
Phase 3 clinical trial study without a control group with two parallel groups without blinding on 50 patients divided into two groups of 25 people receiving standard medication
Settings and conduct
We do the work in the city of Qom. We have two groups of patients for injection. One group of patients with treatment-resistant tension and one group of patients with treatment-resistant migraine. It is done with an insulin syringe and subcutaneously and in the injection areas according to the preempt protocol in migraine patients and dispersion and spasm of painful areas in tension patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients aged 20 to 70 years with treatment-resistant migraine and tension headaches
Exclusion criteria: Age less than 20 and more than 70 years old, presence of neuromuscular diseases, and pregnancy
Intervention groups
We will have two intervention groups: one group of people with treatment-resistant tension headaches and one group of people with treatment-resistant migraine headaches. We will inject each group with the drug and then evaluate them over a period of 3 months
Main outcome variables
Change in frequency (number of headaches per week) ; severity (via VAS scale) ; headache duration (in hours) ; change in quality of life (with WHO questionnaire)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250308064974N1
Registration date:2025-09-29, 1404/07/07
Registration timing:prospective
Last update:2025-09-29, 1404/07/07
Update count:0
Registration date
2025-09-29, 1404/07/07
Registrant information
Name
Fatemeh Tabrizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2000
Email address
tabrizi223@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of botulinum toxin a in patients with migraine headaches and treatment-resistant tension in people aged 20 to 70 years
Public title
Comparison of the effect of botulinum toxin a in patients with migraine headaches and treatment-resistant tension in people aged 20 to 70 in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 20 to 70 years
Patients with treatment-resistant migraine headache
Patients with treatment-resistant tesion headache
Exclusion criteria:
Age less than 20 and more than 70 years
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
First Intervention groupPatients with treatment-resistant chronic migraine headaches are in the first intervention group, receiving botulinum toxin type A subcutaneously with a fine insulin needle according to the preempt protocol.
Category
Treatment - Drugs
2
Description
Intervention group: Patients with treatment-resistant chronic tension headaches are in the second intervention group, who receive botulinum toxin type A subcutaneously with a fine insulin needle in the frontal, temporal, and occipital regions.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti hospital
Full name of responsible person
Fateme Tabrizi
Street address
Beheshti Blvd
City
Qom
Province
Ghoum
Postal code
37719964797
Phone
+98 25 3612 2000
Email
tabrizi223@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Aghaali
Street address
Safashar Street
City
Qom
Province
Ghoum
Postal code
93456-37169
Phone
+98 912 751 5639
Email
dr.aghaali@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Fateme Tabrizi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Beheshti Blvd
City
Qom
Province
Ghoum
Postal code
3719637555
Phone
+98 25 3612 2526
Email
tabeizi223@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Fatemeh Tabrizi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Shahid Beheshti Blvd
City
Qom
Province
Ghoum
Postal code
3719637555
Phone
+98 25 3612 2526
Email
tabrizi223@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Fateme Tabrizi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Blvd Shahid behehsti
City
Qom
Province
Ghoum
Postal code
3719637555
Phone
+98 25 3612 2526
Email
Tabrizi223@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the existence of personal information of patients and in order to protect privacy and observe medical ethics in maintaining patient confidentiality
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available