Comparison of the effects of levetiracetam, sodium valproate and nortriptyline on migraine headaches
Design
In this study, 120 eligible patients with chronic daily headaches who are admitted to the Neurology Clinic of Vali-e-Asr Hospital in Birjand are incorporated. Participants are randomly assigned into one of the three intervention groups.
Settings and conduct
The study is performed in the Neurology Clinic of Vali-e-Asr Hospital in Birjand in a non-blinded manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria consist of presence of migraine headaches (headache attacks over 3 attacks per month; each attack with an interval of more than 48 hours of relief from other attacks); age from 18 to 65 years; non-use of other anti-migraine drugs since at least one month ago; no allergy to levetiracetam, sodium valproate, and nortriptyline or their compounds; absence of acute migraine resistant to treatment; not having severe mental disorders; absence of neurodegenerative disorders; no malignancy; absence of pain disorders; no severe infection; and informed consent for participation.
Exclusion criteria comprise of pregnant or breast-feeding women; irregular consumption of medications; suffering from severe drug side-effects during the course of the study, which may change treatment regimen; treatment-resistant acute migraine; severe psychiatric disorders; drug or alcohol dependence; renal dysfunction; and excessive use of acute migraine drugs.
Intervention groups
Levetiracetam Group: These patients will receive levetiracetam which will start at a dose of 250 milligrams per day in the first week followed by an increased dose of 250 milligrams per week reaching a dose of 1000 milligrams per day in the fourth week.
Sodium Valproate Group: These patients will receive 500 milligrams of sodium valproate per day, starting at 250 mg per day in the first week. In the second week until the end of the fourth week of intervention, patients will receive 500 milligrams per day (250 milligrams twice a day).
Nortriptyline Group: These patients will be prescribed nortriptyline at a dose of 25 milligrams per day throughout the study.
Main outcome variables
Severity of headache, frequency of headache, side effects (digestive, nervous, etc.)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140519017756N39
Registration date:2018-02-20, 1396/12/01
Registration timing:registered_while_recruiting
Last update:2018-02-20, 1396/12/01
Update count:0
Registration date
2018-02-20, 1396/12/01
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-30, 1396/11/10
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of levetiracetam, sodium valproate, and nortriptyline on migraine headaches control in migraine patients
Public title
Effects of levetiracetam, sodium valproate, and nortriptyline on migraine headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of migraine headaches (headache attacks over 3 attacks per month; each attack with an interval of more than 48 hours of relief from other attacks)
Age from 18 to 65 years
Non-use of other anti-migraine drugs since at least one month ago
No allergy to levetiracetam, sodium valproate, and nortriptyline or their compounds
Absence of acute migraine resistant to treatment
Not having severe mental disorders
Absence of neurodegenerative disorders
No malignancy
Absence of pain disorders
No severe infection
Informed consent for participation
Exclusion criteria:
Pregnant or breast-feeding women
Irregular consumption of medications
Suffering from severe drug side-effects during the course of the study, which may change treatment regimen
Treatment-resistant acute migraine
Severe psychiatric disorders
Drug or alcohol dependence
Renal dysfunction
Excessive use of acute migraine drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be allocated into study groups via
permuted block randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2018-01-29, 1396/11/09
Ethics committee reference number
IR.BUMS.REC.1396.313
Health conditions studied
1
Description of health condition studied
Migraine headaches
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache severity
Timepoint
At the end of intervention
Method of measurement
Visual analogue scale
2
Description
Frequency of headache incidence
Timepoint
After intervention
Method of measurement
Patient daily notes during intervention
3
Description
Side effects (digestive, nervous, etc.)
Timepoint
After intervention
Method of measurement
Patient daily notes during intervention
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1 (Levetiracetam): These patients will receive levetiracetam which will start at a dose of 250 milligrams per day in the first week followed by an increased dose of 250 milligrams per week reaching a dose of 1000 milligrams per day in the fourth week.
Category
Treatment - Drugs
2
Description
Intervention Group 2 (Sodium Valproate): These patients will receive 500 milligrams of sodium valproate per day, starting at 250 mg per day in the first week. In the second week until the end of the fourth week of intervention, patients will receive 500 milligrams per day (250 milligrams twice a day).
Category
Treatment - Drugs
3
Description
Intervention Group 3 (Nortriptyline): These patients will be prescribed nortriptyline at a dose of 25 milligrams per day throughout the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic of Valie-Asr Hospital
Full name of responsible person
Dr Hamidreza Riasi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3242 5402
Email
riasi_h@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 2001
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
50
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
Birjand University of Medical Sciences
Full name of responsible person
Zahra Ahani
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5001
Email
Zahra_m305@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Hamidreza Raesi
Position
Neurologist
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5001
Email
riasi_h@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56323956780
Email
hadirooz@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
As part of the conditions set by participants for participation, no data about them can be distributed.
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
study protocol
When the data will become available and for how long
The protocol will be published in a paper and will be available for as long as the paper is reachable.
To whom data/document is available
All readers of the paper
Under which criteria data/document could be used
No certain criteria
From where data/document is obtainable
the journal publishing the paper
What processes are involved for a request to access data/document