The aim of this study is to evaluate the effect of Memantine on decreasing frequency, severity and duration of headaches in patients with chronic migraine.
Design
This study will be done on a double blind randomized controlled clinical trial on 54 patients aged 18-65 years old with chronic migraine headache refereeing to neurology clinic of Hospitals in Ahvaz city.
Settings and conduct
This study was done on patients refereeing to Neurology clinic of Hospitals in Ahvaz city.Patients were divided into two equal groups of intervention and control (number = 27) by block randomization and they had no awarness of grouping way. Pain severity, disability level and frequency of attacks at the beginning of study, at first, second, third, and fourth month were recorded in follow-ups. The severity of headache was measured using the visual analog scale and the disability level was measured using the Migraine Disability Assessment Test Survey.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 18 to 65 years old;
Chronic migraine headache according to International Classification of headache.
Exclusion Criteria: Pregnancy or breast-feeding;
Renal or hepatic impairment or known cardiovascular disease;
History of allergy to memantine and topiramate.
Intervention groups
Intervention group: receiving Memantin and Topiramate
Control group: receiving Placebo and Topiramate
Main outcome variables
Severity of migraine headache attacks; Disability level of migraine headache attacks; Frequency of migraine headache attacks; Duration of migraine headache attacks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191205045623N1
Registration date:2019-12-26, 1398/10/05
Registration timing:retrospective
Last update:2019-12-26, 1398/10/05
Update count:0
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Sahereh Emadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3012
Email address
sahere.emadi.64@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-20, 1396/01/31
Expected recruitment end date
2017-09-20, 1396/06/29
Actual recruitment start date
2017-04-20, 1396/01/31
Actual recruitment end date
2017-11-18, 1396/08/27
Trial completion date
2018-03-19, 1396/12/28
Scientific title
The effectiveness of adding Memantine to Topiramate in the prevention of headache attacks among patients with chronic migraine headaches
Public title
Prophylactic Effect of Memantine on Chronic Migraine Headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 65 years old
Chronic migraine headache according to International Classification of headache
Exclusion criteria:
Pregnancy or breast-feeding
Renal or hepatic impairment or known cardiovascular disease
History of allergy to memantine and topiramate
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
54
Actual sample size reached:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method was used for randomization. Nine blocks were created by www.randomizer.org. The blocks were the same size and equal to 6. In each block, there were three allocations for the intervention group and three allocations for the control one. In each block, 1 and 2 numbers were given in different order, which determined the group of patients. Number one was considered as intervention group and number two was used as control group. Patients were randomly assigned to intervention or control groups after diagnosis of chronic migraine on the basis of one and two numbers in blocks.Also the random sequence of blocks was in the hands of an individual other than the researcher who, by telephone, provided only the required number indicating the intervention or control group. Without researchers intervention, the patients were assigned to each groups based on numbers. After sampling accomplisehed, each groups had the same size with number of 27.
Blinding (investigator's opinion)
Double blinded
Blinding description
None of the patients in this study knew that they were in the intervention or control group and that the treatment received was either drug or placebo. Also, none of the researchers had a direct role in the process of grouping and follow up of patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Development Research and Technology, Ahwaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-04-20, 1396/01/31
Ethics committee reference number
IR.AJUMS.REC.1396.630
Health conditions studied
1
Description of health condition studied
Migraine headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
The severity of migraine headache attacks
Timepoint
This evaluation was performed at the beginning of the study, and the end of first, second, third and fourth months of the study.
Method of measurement
Visual Analogue Scale
2
Description
The disability level of migraine headache attacks
Timepoint
This evaluation was performed at the beginning of the study, and the end of first, second, third and fourth months of the study.
Method of measurement
Migraine Disability Assessment Test Survey (MIDAS)
3
Description
The frequency of migraine headache attacks
Timepoint
This evaluation was performed at the beginning of the study, and the end of first, second, third and fourth months of the study.
Method of measurement
Daily headache diary
4
Description
The duration of migraine headache attacks
Timepoint
This evaluation was performed at the beginning of the study, and the end of first, second, third and fourth months of the study.
Method of measurement
Daily headache diary
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in intervention group received Memantine tablet 20 mg daily which reached this level after 4 weeks and they received topiramate tablet 50 mg daily as a base medication which started at 25 mg daily and increased to 50 mg daily in two weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients in control group received placebo that it was similar to memantine tablet in shape and color and they received topiramate tablet 50 mg daily as a base medication which started at 25 mg daily and increased to 50 mg daily in two weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Sahereh Emadi
Street address
Clinic of Neurology, Golestan Hospital, Farvardin St., Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Email
sahere.emadi.64@gmail.com
2
Recruitment center
Name of recruitment center
Imam khomeyni Hospital
Full name of responsible person
Sahereh Emadi
Street address
Clinic of neurology, Imam khomeyni Hospital, Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2818
Email
sahere.emadi.64@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Development Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
http://vchresearch.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Davood Kashipazha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Golestan Hospital, Farvardin St., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Email
dakashi47@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Davood Kashipazha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Golestan Hospital, Farvardin St., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Email
dakashi47@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahereh Emadi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Golestan Hospital, Farvardin St., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Fax
Email
sahere.emadi.64@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