Evaluation of the prophylactic effect of magnesium versus placebo in reduction of frequency, severity and duration of migraine headaches in children aging 6-18 years old
In this study, we intend to evaluate the effect of magnesium + propranolol versus placebo + propranolol in pediatrics afflicted with migraine.
Design
A randomized double-blind placebo-controlled phase 3 clinical trial with parallel design. 140 patients are randomized to 2 groups and take the aforementioned medications for 3 months and complete a migraine diary. randomization is done using random table.
Settings and conduct
The study is performed in Pediatrics neurology unit of Imam Reza clinic in Shiraz city, a governmental facility. eligible patients are randomized and provided with appropriate medications with identical shapes and packaging and, followed up for 3 months. studying physicians and patients are blind to the study group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children with 6-18 years of age and weights less than 90 Kg, having migraine diagnosed according to IHSC-3 criteria with at least 4 migraine attacks per month or 8 days-of-headache per month in the past month.
Exclusion Criteria:
Coexistence of another type of headache; having migraine headaches or using analgesics on at least 15 days per month; history of epilepsy or neurological comorbidity; mental retardation; Addiction; magnesium contraindications; propranolol contraindications; history of using migraine prophylaxis medications or magnesium supplements in the past month; history of psychiatric disorders; patient's poor medication compliance;
Illiteracy of the patient and family
Intervention groups
Half of the patients take Magnesium Oxide 10 mg/kg/day and another half take identical placebo; in addition, both groups also receive Propranolol 0.5 mg/kg/day. after the first visit, patients are evaluated 4 weeks and 12 weeks after the initiation.
Main outcome variables
Amount of reduction in frequency of migraine attacks is the primary outcome of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221115056506N1
Registration date:2023-02-06, 1401/11/17
Registration timing:prospective
Last update:2023-02-06, 1401/11/17
Update count:0
Registration date
2023-02-06, 1401/11/17
Registrant information
Name
Mohammad Akrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3340 8199
Email address
stud4180194406@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the prophylactic effect of magnesium versus placebo in reduction of frequency, severity and duration of migraine headaches in children aging 6-18 years old
Public title
Evaluation of magnesium effect in treatment of migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age from 6 to 18 years old
Weight less than 90 Kg
Diagnosed as migraine according to IHSC-3 criteria
At least 4 migraine attacks in month or 8 days-of-headache during at least 1 month ago
Exclusion criteria:
Coexistence of another type of headache
Migrainous headache in at least 15 days per month
Using analgesic medications in at least 15 days per month
Pregnancy or intention of pregnancy
History of epilepsy or other neurological comorbidities
Mental retardation defined as IQ<70
Dependency or addiction to pharmaceutical or illicit drugs
Magnesium administration contraindications
Renal failure
History of renal stone
Propranolol administration contraindications
Cardiac conduction block
Bradycardia
History of asthma
History of hypersensitivity reaction to propranolol
Diabetes mellitus
Liver insufficiency
Myasthenia gravis
Psoriasis
History of using migraine prophylaxis medications in the past month
History of using magnesium supplements in the past month
History of psychiatric disorders including depression, mood disorders, anxiety disorders or psychotic disorders
History of using anti-depressants, anti-psychotics, mood stabilizers or sedatives
Anticipation of patient's poor medication compliance
Illiteracy of the patient and family and, inability of filling the diary
Age
From 6 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed via block randomization method comprising 35 blocks of 4 individuals using statistical software and, the random sequence of the study is made beforehand. allocation concealment is ensured by putting unique patient-numbers on medication packets and, delivered to the patient upon entering to the study according to the random sequence while, researcher is unaware of the allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Initially, informed consent, demographic and baseline information are obtained. Patient and physician are blind to the intervention groups. Patients' allocated groups are written down in a notebook by physician assistant and will be revealed at the end of the study. Randomization is performed by the assistant and medication delivery is done in the clinic by another assistant. Magnesium oxide pills and placebo are given in identical small packets with identical labeling. Propranolol tablets are given in its standard factory-made packages.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-07-04, 1401/04/13
Ethics committee reference number
IR.SUMS.MED.REC.1401.258
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Frequency of migraine attacks per month
Timepoint
At the beginning; then, 4 weeks later; then, 12 weeks after the initiation
Method of measurement
Direct asking of the patient in the first visit; then, using migraine diary in the following visits
Secondary outcomes
1
Description
Severity of pain during migraine attacks
Timepoint
First visit; 4 weeks later; 12 weeks later
Method of measurement
Wong-baker scale
2
Description
Average duration of migraine attacks per month
Timepoint
First visit; 4 weeks later; 12 weeks later
Method of measurement
direct asking and migraine diary
3
Description
Amount of analgesic medications used
Timepoint
First visit; 4 weeks later; 12 weeks later
Method of measurement
direct asking and migraine diary
Intervention groups
1
Description
Intervention group: Magnesium oxide 10 mg/kg in 1 or 2 divided dose for 3 months should be used. Generic Magnesium Oxide 250 mg tablets from Jalinus pharmaceutical company are used. patients are also provided with Propranolol 0.5 mg/kg/day.
Category
Treatment - Drugs
2
Description
Control group: Placebo with complete resemblance to magnesium oxide pills with similar usage order produced by the pharmaceutical laboratory of Shiraz school of pharmacy. patients are also provided with Propranolol 0.5 mg/kg/day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza clinic in Shiraz
Full name of responsible person
Pegah Katibeh
Street address
Namazi Sq.
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7001
Email
emamreza@sums.ac.ir
Web page address
https://emamreza.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
https://research.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Pegah Katibeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics neurology
Street address
Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3612 5849
Email
Pegah_katibeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Pegah Katibeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3612 5849
Email
Pegah_katibeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Akrami
Position
Student of medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Mohammadi st.
City
KhorramAbad
Province
Lorestan
Postal code
6818763197
Phone
+98 66 3340 8199
Fax
Email
stud4180194406@sums.ac.ir
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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All patients' data would be available after anonymization.
When the data will become available and for how long
Data would be available to public after publication of the article.
To whom data/document is available
Data is only provided for scientific purposes to researchers.
Under which criteria data/document could be used
Data will be available for research purposes.
From where data/document is obtainable
Please contact Dr. Pegah Katibeh or Dr. Mohammad Akrami via Email.
What processes are involved for a request to access data/document
After evaluation of request, data will be provided in fastest time possible and no specific legal pathway is in consideration.