Protocol summary

Summary
The aim of this study is to compare the efficacy of magnesium with sodium valproate as prophylactic therapy in adult patients with a diagnosis of migraine headache based on the latest International Headache Society criteria. Study design is randomized, double-blind and prospective. These subject (228 patients) will be entered in the study with a personal satisfaction with regard to the inclusion and exclusion criteria and will be assigned randomly into one out of three groups: 250 mg twice a day magnesium oxide (n=76), 200 mg twice a day sodium valproate (n=76), magnesium oxide (250 mg twice daily) and sodium valproate (200 mg once per day) concurrently (n=76). The study duration from beginning of drug prescription will be 3 month. The primary objective of the study is to compare the frequency and severity of migraine headaches based on Wong-Baker Faces Pain Rating Scale at the end of month 1, 2 and 3 in three groups. Follow up visits will be scheduled every 4 weeks to 12 weeks. To evaluate blood and liver side effects of drugs, CBC, diff, AST, ALT tests will be performed at the start of therapy and the end of 12 weeks of the study. Finally, the severity, frequency, duration of headache, side effects and amount of analgesics needed during a migraine attack will be compared in the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015081923685N1
Registration date: 2015-10-11, 1394/07/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-10-11, 1394/07/19
Registrant information
Name
Samira Khani
Name of organization / entity
Qom University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 25 3783 2370
Email address
skhani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of magnesium compared with sodium valporate in migraine headache prophylaxis
Public title
Comparison of magnesium and sodium valporate in migraine prophylaxis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients diagnosed with migraine according to the latest International Headache Society criteria; history of migraine with or without aura for at least 6 months; patient’s age between 18-65 years; at least 2 attacks monthly. Exclusion criteria: non-migraine headaches (total number of headache days per month more than 15); overuse of analgesics in migraine attacks (consumption of ergots, NSAIDs and triptans more than 8 days a month); substance and alcohol dependence; illiteracy of patients and their family (unable to fill diaries); pregnancy and breast feeding; any previous history of magnesium or sodium valporate intolerance; history of renal, liver and chronic disease; elevated liver enzymes in the first sampling more than 2 times the normal; neurologic disorders other than migraine; use of supplements that contain magnesium, calcium and riboflavin; use of herbal anti-migraine; use of anti-depressant and anti-psychotic medications.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 228
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block randomization sampling will be used in this study.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
No. 83, alley 4 ,St. 1.1, Safashahr Ave., Qom
City
Qom
Postal code
Approval date
2015-09-07, 1394/06/16
Ethics committee reference number
IR.MUQ.REC.1394.73

Health conditions studied

1

Description of health condition studied
Migraine with aura
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura [classical migraine]

2

Description of health condition studied
Migraine without aura
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]

Primary outcomes

1

Description
Severity of hedache
Timepoint
In each migraine attack
Method of measurement
The patient will record the severity of headache in each attack based on Wong-Baker Faces Pain Rating Scale using diary and these notes will be registered every 4 weeks by physician.

2

Description
duration of headache
Timepoint
In each migraine attack
Method of measurement
patient will record the hours of headache in each attack , physician will register them every 4 weeks.

3

Description
frequency of headaches
Timepoint
every 4 weeks
Method of measurement
According to patients daily notes

4

Description
Analgesic use
Timepoint
every 4 weeks
Method of measurement
According to patients daily notes

Secondary outcomes

1

Description
clinical side effects
Timepoint
every 4 weeks
Method of measurement
According to patient daily notes

2

Description
Laboratory side effects (Blood cell count & liver function test changes)
Timepoint
before the treatment course and at the end of 12 weeks
Method of measurement
lab tests

Intervention groups

1

Description
Intervention group 3: Sodium valporate tablet 200 mg once a day orally, for 12 weeks. Magnesium tablet 250 mg twice a day orally, for 12 weeks
Category
Treatment - Drugs

2

Description
Intervention group 2: Sodium valporate tablet 200 mg twice a day orally, for 12 weeks. Placebo tablet once a day orally, for 12 weeks.
Category
Treatment - Drugs

3

Description
Intervention group 1: Magnesium tablet 250 mg twice a day orally, for 12 weeks. Placebo tablet once a day orally, for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Seyed Shamsodin Hejazi
Street address
Qom, Shahid Beheshti bovd.
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Qom University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
Qom
City
No. 83, alley 4 ,St. 1.1, Safashahr Ave., Qom
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, Qom University of Medical Sciences
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
School of Medicine , Qom University of Medical Sciences
Full name of responsible person
Dr. Samira Khani
Position
Pharmacology Ph.D., assistant professor
Other areas of specialty/work
Street address
East Street No. 2, Moallem Blvd., School of Medicine
City
Qom
Postal code
Phone
+98 25 3783 2370
Fax
Email
pharma_75@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Science
Full name of responsible person
Dr. Seyed Shamsodin Hejazi
Position
Neurologist
Other areas of specialty/work
Street address
Shahid Beheshti hospital , Shahid Beheshti blvd, Qom,
City
Qom
Postal code
Phone
+98 25 3612 2000
Fax
Email
ssh_hejazi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Science
Full name of responsible person
Dr. Samira Khani
Position
Pharmacology Ph.D, assistant professor
Other areas of specialty/work
Street address
Moallem Blvd., school of Medicine
City
Qom
Postal code
Phone
+98 25 3783 2370
Fax
Email
pharma_75@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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