The studies on lacosamide are very limited, and there have been no comparative studies on lacosamide and topiramate in the prevention of migraine attacks. Given the high prevalence of migraines and the lack of effective preventive treatments, it is essential to investigate effective therapies and compare them to achieve the best treatment methods. Therefore, the aim of the present study is to compare the clinical effects and side effects of lacosamide with topiramate in the control of migraine headaches over a period of 3 months.
Design
A clinical trial with a control group, using a parallel three-arm double-blind design, involving 60 patients.
Settings and conduct
The study participants include all patients with diagnosed migraine headaches who are referred to Shahid Beheshti Hospital in Qom and are selected through simple random sampling. After entering the study and obtaining consent, diagnostic and therapeutic measures are performed for all patients upon entry into the study according to the protocol for managing patients, based on the decision of the responsible physician.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Individuals with migraine headaches
Exclusion Criteria:
Individuals under 18 years of age
Pregnant women
Individuals with cardiovascular diseases
Intervention groups
The study participants include all patients with diagnosed migraine headaches who are referred to Shahid Beheshti Hospital in Qom.
Main outcome variables
Studies on lacosamide are very limited, and there have been no comparative studies on lacosamide and topiramate in the prevention of migraine attacks. Given the high prevalence of migraines and the lack of effective treatments for preventing migraine attacks, it is essential to investigate effective therapies and compare them to achieve the best treatment methods.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240930063218N1
Registration date:2024-12-19, 1403/09/29
Registration timing:registered_while_recruiting
Last update:2024-12-19, 1403/09/29
Update count:0
Registration date
2024-12-19, 1403/09/29
Registrant information
Name
Mohammad javad Khadem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5382 3385
Email address
dr.mohammadjavadkhadem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-31, 1403/08/10
Expected recruitment end date
2025-01-29, 1403/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the clinical effect and side effects of lacosamide with topiramate in controlling migraine headaches during 3 months
Public title
Comparison of the clinical effect and side effects of lacosamide with topiramate in controlling migraine headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with migraine headache
Exclusion criteria:
Under 18 years old
Pregnant women
Cardiovascular diseases
Patients are treated with pre-determined drug packages by the study supervisor (supervisor). The drug packages are identical in appearance, and both the patient and the study implementer are unaware of the contents of the packages. Additionally, data collection, patient assessment, and form completion are carried out by the study implementer and their assistant, who are also unaware of the contents of the packages. In the data analysis phase, the analysis is conducted by the study supervisor and the study implementer, who are unaware of the contents of the drug packages, and only the patient groups (Group 1 or Group 2) are identified for data analysis. Therefore, the study is triple-blind, and from the moment the patient enters the study until the completion of the study, data collection, and information analysis, the contents of the two drug groups remain unknown.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Shahid beheshti
City
Qom
Province
Ghoum
Postal code
3719964797
Approval date
2024-07-22, 1403/05/01
Ethics committee reference number
IR.MUQREC.1403.118
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Intensity and frequency of headaches
Timepoint
3 months
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This study is designed as a triple-blind randomized clinical trial. All patients meeting the inclusion criteria will be considered for participation in the study at the time of enrollment. After obtaining written informed consent and explaining the study conditions, patients will be asked to rate their pain level based on the VAS scale. They will then be randomly assigned to one of the study groups. The first group will receive topiramate (manufactured by Darou Pakhsh Company, Tehran, Iran), and the second group will receive lacosamide (manufactured by Caspian Darou Company, Rasht, Iran). It is important to note that patients receiving lacosamide will also be monitored with ECG.In the lacosamide group, patients will receive 100 mg of lacosamide twice daily in the first week, 150 mg every 12 hours in the second week, and 200 mg twice daily in the third week, if tolerated. In the topiramate group, patients will receive 25 mg of topiramate once daily in the first week, followed by 25 mg twice daily thereafter.Patients will be grouped based on the Balanced Randomization method into two groups, A and B. Both analgesic medications will be placed in boxes A and B, with only the responsible physician (the principal investigator) aware of the contents of each group. Each patient will then be assigned a number by the principal investigator, which will be recorded in a notebook. For example, patient number 1 will receive medication A, and patient number 2 will receive medication B, or vice versa, with the blinding method explained below.It is worth noting that both groups of patients will continue their routine migraine treatment, and routine treatment will not be discontinued. In the event of a headache, patients will be given analgesics to ensure they receive effective treatment, which will include various NSAIDs.
Category
Treatment - Drugs
2
Description
Intervention group: In the lacosamide group, patients will receive 100 mg of lacosamide twice daily in the first week, 150 mg every 12 hours in the second week, and 200 mg twice daily in the third week, if tolerated. In the topiramate group, patients will receive 25 mg of topiramate once daily in the first week, followed by 25 mg twice daily thereafter
Category
Treatment - Drugs
3
Description
Control group: In the topiramate group, patients will receive 25 mg of topiramate once daily in the first week, followed by 25 mg twice daily thereafter.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom shahid beheshti hospital
Full name of responsible person
Mohammad javad khadem
Street address
Shahid beheshti street
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
dr.mohammadjavadkhadem@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Research Department
Street address
Shahid beheshti street
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
dr.mohammadjavadkhadem@gmail.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
Research DepartmentResident
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Shahid beheshti street
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
dr.mohammadjavadkhadem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Fereshteh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shahid beheshti street
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
darkness.8090100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad javad khadem
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Shahid beheshti street
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
dr.mohammadjavadkhadem@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