Evaluating the effect of Lacosamide treatment on the severity of headache attacks and CGRP-LI levels in people with migraine: A triple-blind randomized clinical trial
To evaluate the effects of Lacosamide treatment on the severity of migraine attacks and CGRP-LI levels using a triple-blind randomized clinical trial
Design
Triple-blind randomized clinical trial, where patients, prescribing physicians, and investigators are blinded to group allocation
Settings and conduct
The clinical trial is a triple-blind randomized study conducted at Imam Khomeini Hospital Complex's Neurology Clinic, Tehran University of Medical Sciences, Iran
Participants/Inclusion and exclusion criteria
Patients aged 18-45 diagnosed with migraine based on ICHD-3 criteria, and have not used any preventive medication in the past month
Intervention groups
Intervention Group: Receives Lacosamide (50 mg BID) daily for 3 months
Placebo Group: Receives identical-looking placebo for 3 months
Main outcome variables
Measurement of CGRP-LI levels via ELISA test and migraine severity using MIDAS questionnaire before and after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250525065882N1
Registration date:2025-06-15, 1404/03/25
Registration timing:prospective
Last update:2025-06-15, 1404/03/25
Update count:0
Registration date
2025-06-15, 1404/03/25
Registrant information
Name
Iman Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2284 8546
Email address
i-kiani@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-21, 1404/03/31
Expected recruitment end date
2025-12-04, 1404/09/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Lacosamide treatment on the severity of headache attacks and CGRP-LI levels in people with migraine: A triple-blind randomized clinical trial
Public title
Lacosamide in Migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients' age should be between 18 and 45 years
They must have migraine disease according to the ICHD-3 criteria
They must not have used migraine preventive medication in the past month
The patient must have the ability to respond to questions
Exclusion criteria:
Lack of patient consent to participate in the study
Lacosamide medication interfere with other drugs received by the patient
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random number table, patients will be randomly assigned to intervention and control groups. The table consists of a large set of numbers generated without a specific pattern and organized into a structured format. To apply this method, the researcher first designates sequential numbers for different groups, such as 0-22 for the intervention group and 23-44 for the placebo group. The researcher then selects a starting number, proceeds in a predetermined direction, records the numbers, and allocates them accordingly to the designated groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, both the patients and the prescribing physician will remain unaware of the nature of the drug and placebo, as well as the randomization process. Additionally, the researcher and statistical consultant will serve as a third blinded arm and will be subject to blinding procedures. An external observer will be aware of the drug and placebo but will have no role in their allocation. The placebo will be identical to the drug in terms of size, color, volume, and packaging. The required placebo will be sourced from the pharmaceutical company Kondor Pharma.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Neuroscience Institute
Street address
Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733131
Approval date
2025-02-04, 1403/11/16
Ethics committee reference number
IR.TUMS.NI.REC.1403.059
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Migraine duration
Timepoint
Month
Method of measurement
Ask the patient
2
Description
Migraine intensity
Timepoint
Baseline (before treatment) and after 3 months
Method of measurement
MIDAS questionnaire, completed by patients
3
Description
The concentration of Calcitonin Gene-Related Peptide (CGRP-LI) in the blood, linked to migraine
Timepoint
Baseline (before treatment) and after 3 months
Method of measurement
ELISA test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive Lacosamide medication daily at a dose of 50 mg provided by Actover Company for a duration of three months.
Category
Treatment - Drugs
2
Description
Intervention group: The placebo group will receive the placebo for three months at the same dosage as the medication prescribed to the other group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Abbas Tafakhori
Street address
End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 911 156 3230
Email
abbas.tafakhori@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
021 - 88989664
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Iman Kiani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Jalal blvd.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 912 321 0451
Email
iman.kiani.n@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Tafakhori
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 911 156 3230
Email
abbas.tafakhori@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Faezeh Sadat Sharifian
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Kargar st
City
Tehran
Province
Tehran
Postal code
1419974975
Phone
+98 904 408 8079
Email
faezehsadatsharifian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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