The effect of Memantine on migraine pain severity,mental health and quality of life in patients with migraine.
Design
Clinical trial with control group, with parallel groups, randomized, phase 3 on 84 patients. SPSS software was used for randomization.
Settings and conduct
This study was performed on 84 patients with migraine in Isfahan. The subjects were selected from among the patients referred to the neurology clinics of Imam Musa Sadr Clinic and Khorshid Hospital with the diagnosis of a neurologist. Topiramate With dosage 50 mg daily and in the intervention group, in addition to topiramate, memantine is used at a dose of 10 mg daily for two months as prophylaxis. To assess the quality of life and mental health of patients, questionnaires (Headache Impact Test: HIT And PHQ: Patient Health Question) and Visual Analogue Scale (VAS) is completed by patients before and two months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patient satisfaction
Having a migraine criterion based on the International Headache Association criteria
Exclusion criteria:
History of addiction to any drug
Treated with herbal medicines and other palliative medicine treatments
Treated with other prophylactic drugs
Concomitant treatment with corticosteroids
Intervention groups
For the intervention group, memantine at a dose of 10 mg daily for two months is used as prophylaxis. Also, in both groups (control group and memantine receiving group), topiramate with dosage 50 mg daily is used prophylactically for two months. Topiramate was used once a night in this study, but the patient is responsible for the time of taking memantine and the specific time of day and night has no effect on its effect.
Main outcome variables
Pain severity; mental health; Quality of Life; Number of headaches; The duration of the headache.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038142N21
Registration date:2020-09-21, 1399/06/31
Registration timing:retrospective
Last update:2020-09-21, 1399/06/31
Update count:0
Registration date
2020-09-21, 1399/06/31
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-21, 1398/05/30
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
2019-08-21, 1398/05/30
Actual recruitment end date
2020-05-11, 1399/02/22
Trial completion date
2020-08-20, 1399/05/30
Scientific title
The effect of Memantine on migraine pain severity,mental health and quality of life in patients with migraine
Public title
The effect of Memantine in migraine patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction
Having a migraine criterion based on the International Headache Association criteria
Exclusion criteria:
History of addiction to any drug
Treated with herbal medicines and other palliative medicine treatments
Treated with other prophylactic drugs
Treated with corticosteroids
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is non-probabilistic and sequential. In this way, all patients who are eligible to enter the study, enter the study until the sample size is completed. Then, using SPSS computer software, they are randomly assigned to two groups of control and intervention.
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 Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave., Isfahan University of Medical Sciences.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.MUI.MED.REC.1398.201
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Quality of life
Timepoint
Before and two months after the start of the intervention
Method of measurement
Headache Impact Test: HIT
2
Description
Mental Health
Timepoint
Before and two months after the start of the intervention
Method of measurement
Patient Health Question questionnaire: PHQ
3
Description
Severity of headache
Timepoint
Before and two months after the start of the intervention
Method of measurement
Visual Analogue Scale
4
Description
Duration of headache per attack
Timepoint
Before and two months after the start of the intervention
Method of measurement
Question from the patient
5
Description
Number of headaches per week
Timepoint
Before and two months after the start of the intervention
Method of measurement
Question from the patient
Secondary outcomes
empty
Intervention groups
1
Description
Control group:In this group, there are 42 patients with migraine who use topiramate at a dose of 50 mg made by Sobhan Iranian Pharmaceutical Company. This drug is used daily for two months as a prophylaxis. Topiramate is used once a night in this study.
Category
Treatment - Drugs
2
Description
Intervention group: For the intervention group, memantine at a dose of 10 mg daily for two months is used as prophylaxis. Also, topiramate at a dose of 50 mg daily for two months is used as prophylaxis. Topiramate was used once a night in this study, but the patient is responsible for the time of taking memantine and the specific time of day and night has no effect on its effect.