The present study is designed with the aim of evaluating the efficacy and tolerability of Memantine for tension-type headache. This is a prospective randomized, open-label, clinical trial which will be conducted on patients with tension-type headache referred to Emam Reza outpatient clinic (Shiraz, Iran) based on eligibility criteria during 3-month period. The patients will be randomly assigned to receive Memantine (5-15mg) or Amitriptyline (20mg) for three months. Baseline characteristics of the participants include age, gender, BMI, and medication treatment schedules will be obtained by a date gathering form. As the primary outcome, migraine disability assessment scale will be measured before and after intervention. In addition, we will be considered the number of days with headache per month, and headache severity as secondary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081635710N2
Registration date:2017-09-17, 1396/06/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-17, 1396/06/26
Registrant information
Name
Ehsan Jelodari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5884
Email address
e_jelodari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-09-01, 1396/06/10
Expected recruitment end date
2017-12-30, 1396/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To survey the effects of Memantine in comparison routine treatment for improving tension-type headache
Public title
Effects of Memantine on tension-type headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with confirmed tension-type headache; Aged between 18 and 65 years. Exclusion criteria: Patients with the history of smoking, or alcohol; Pregnancy or breastfeeding; Use of antipsychotics or antidepressants in the past 3 months
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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done using a randomization table based on the registration number of the patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St
City
Shiraz
Postal code
Approval date
2017-07-09, 1396/04/18
Ethics committee reference number
IR.SUMS.REC.1396.59
Health conditions studied
1
Description of health condition studied
tension-type headache
ICD-10 code
G44.2
ICD-10 code description
Chronic tension-type headache
Primary outcomes
1
Description
Migraine disability assessment scale
Timepoint
Before intervention - 3 months after intervention
Method of measurement
MIDAS questionnaire
Secondary outcomes
1
Description
Headache severity
Timepoint
Before intervention - 3 months after intervention
Method of measurement
Visual analogue scale
2
Description
Number of headache days per month
Timepoint
Before intervention - 3 months after intervention
Method of measurement
patients' self-report
Intervention groups
1
Description
Intervention group: Memantine (5-15mg) every day for 3 months
Category
Treatment - Drugs
2
Description
Control group: Amitriptyline (20mg) every day for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic
Full name of responsible person
Ehsan Jelodari
Street address
Namazi square, Shahid Motahari Clinic
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University Of Medical Science
Full name of responsible person
Dr. Seyed Baser Hashemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University Of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Jelodari
Position
Resident of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Shahid Motahari Clinic, Namazi square, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3612 1000
Fax
Email
ehsan2313@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoume nazeri
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Neurology, Shahid motahari Clinic, Namazi square, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3612 1000
Fax
Email
nazerim@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Jelodari
Position
Resident of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Shahid Motahari Clinic, Namazi square, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3612 1000
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)