Comparison the effects of memantine and sodium valproate in migraine pain prophylaxis
Design
The clinical trial in phase 3 has two groups, community-based with parallel groups, double-blind and pseudo randomization methods
Settings and conduct
Migraine patients referring to neurology clinics of Ardabil University of Medical Sciences will be reviewed. This study will be done as double-blinded form (blindness of patients, researcher and physicians). Patients will be divided into two groups of 40 by pseudo randomization method. We will use Memantine for a group and sodium valproate for another group for 12 weeks. After taking their medications, patients do not receive any medication for 4 weeks.Then we will give memantine to sodium valproate group and sodium valproate to memantine group for another 12 weeks. Patients will be visited every four weeks by their neurologist according to a pre-prepared questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Migraine history, more than 3 headache attacks per month, prophylactic treatment failure with one or more migraine prevention drugs, aged 16 to 65 years, spacing more than 48 hours between attacks
Exclusion criteria: Other headaches, use of other migraine prevention medications, drug dependence on drugs or alcohol, renal failure, excessive use of acute migraine attack drugs
Intervention groups
Group 1: These patients will receive 10mg of memantine coated tablets per day and will be continued for 12 weeks. Group 2: These patients will receive 400mg of sodium valproate coated tablets daily and will continue for 12 weeks. Then patients will not take any drug for 4 weeks and then will be given sodium valproate to patients in group 1 and memantine to patients in group 2 for 12 weeks
Main outcome variables
Headache score by MIDAS score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180624040229N1
Registration date:2019-01-02, 1397/10/12
Registration timing:retrospective
Last update:2019-01-02, 1397/10/12
Update count:0
Registration date
2019-01-02, 1397/10/12
Registrant information
Name
Rogayye Dargahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 0739
Email address
arumail@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-10-12, 1397/07/20
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-10-12, 1397/07/20
Trial completion date
2018-10-12, 1397/07/20
Scientific title
Comparison the effects of memantine and sodium valproate in migraine pain prophylaxis
Public title
Comparison the effects of memantine and sodium valproate in migraine pain prophylaxis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
A history of migraines based on the criteria of the international community of headache.
The number of headache attacks is more than three attacks per month.
Failure of prophylactic treatment with one or more migraine prevention drugs.
Any headache attack with more than 48 hours of analgesia should be distinguished from other attacks
Filling out the consent form of the Clinical trial
age 16 to 65
Exclusion criteria:
Other headache
Use of other migraine prevention medications
Drug dependence on drugs or alcohol
Renal dysfunction
Excessive use of acute migraine attack drugs (more than 8 days in the month of receiving ergots, NSAIDs or tryptans)
Sensitization to memantine or sodium valproate or their compounds.
Acute resistant migraine
Severe psychiatric disorders (bipolar disorder, mental disorder, severe depressive disorder, obsessive-compulsive disorder, or functional disorder, general anxiety disorder, Somatization)
Neurodegenerative disorders
malignancy , pain disorder, severe infection
Pregnant or Breastfeeding women
Age
From 16 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The way of participant blindness is that he will receive and use a certain number of drugs in an unnamed and labeled envelope. The way of physicians blindness is that after he has been diagnosed migraine to his patient and notice his secretary, randomly given one of the envelopes to the patient. The way of researcher's blindness is that he will not be present in the filling envelopes and selecting them.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
No. 1, Moallem street,
City
Ardabil
Province
Ardabil
Postal code
5613843793
Approval date
2017-10-23, 1396/08/01
Ethics committee reference number
IR.ARUMS.REC.1396.80
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura
Primary outcomes
1
Description
Headache score by MIDAS score
Timepoint
At the beginning , 3 month later, 6 month later
Method of measurement
MIDAS score
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Memantine, 5 mg oral tablet (Sobhan company), twice a day for 12 weeks. Then 4 weeks without taking any medication. Then take 200 mg of sodium valproate (Raha company), twice a day for 12 weeks
Category
Treatment - Drugs
2
Description
Second Intervention group: Sodium valproate, 200 mg oral tablet (Raha company), twice a day for 12 weeks. Then 4 weeks without taking any medication. Then take 5 mg of Memantine (Sobhan company), twice a day for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Meysam Fouladi
Street address
Royan clinic, Pasdaran St
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
Reseteam.2020@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Parvaneh Naftchi
Street address
Ardabil university of medical sciences, Daneshgah St
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2247
Email
info@arums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Vahid Abbasi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No 1, Moallem St
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
reseteam.2020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Vahid Abbasi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No. 1, Moallem St
City
Ardabil
Province
Ardabil
Postal code
5613843739
Phone
+98 45 3323 0739
Email
reseteam.2020@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Vahid Abbasi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No 1, Moallem St
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
reseteam.2020@gmail.com
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
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After unidentified people, demographic data and MIDAS score will be used to evaluate the headache.
When the data will become available and for how long
Starting the access from 2020
To whom data/document is available
Access will be free for everyone
Under which criteria data/document could be used
Statistical analyzes are allowed on data
From where data/document is obtainable
Will be contact by Dr Abbasi`s email
What processes are involved for a request to access data/document