Find A New Drug Method to Prevent Migraine Headaches
Design
Clinical trial without control, with parallel groups, randomized
Settings and conduct
In this study, children with migraine who referred to Imam Hossein and Amin hospitals in Isfahan university of science are evaluated. The participants are randomly divided in to two groups. The first group is treated with 50 mg/kg L-carnitine daily. The second group is treated with 1 mg/kg Propranolol daily. The headache severity, headache frequency and headache duration are compared between two groups 2 weeks, 1 month and 3 months after beginning of treatment.
Participants/Inclusion and exclusion criteria
Children with migraine whose disease has recently been diagnosed according to the International Headache Society (IHS) criteria, are currently under no preventive treatment and have at least a weekly migraine headache; Patients who have more than four headache attacks in a month (severe migraine forms) are not included in the study.
Intervention groups
In this study, participants are divided in to two groups. The first group is treated with 50 mg/kg L-Carnitine once a day. The second group is treated with 1 mg/kg Propranolol once a day. Then. headache duration, headache severity and headache frequency are compared between two groups.
Main outcome variables
Headache severity, headache duration, headache frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190128042533N1
Registration date:2019-03-02, 1397/12/11
Registration timing:registered_while_recruiting
Last update:2019-03-02, 1397/12/11
Update count:0
Registration date
2019-03-02, 1397/12/11
Registrant information
Name
Omid Yaghini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3234 1294
Email address
yaghini@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-22, 1397/11/02
Expected recruitment end date
2019-04-22, 1398/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of L-Carnitin and Propranolol in Prophylaxis of Headache Attacks in Migrainous Children
Public title
The Effect of L-Carnitin in Treatment of Migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with migraine whose disease has recently been diagnosed with the International Headache Society (IHS) criteria.
Not currently under any preventive treatment.
Have a migraine headache for at least once a week.
Exclusion criteria:
Patients who have more than four headache attacks in a month (severe migraines)
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Science
Street address
Isfahan University of Medical Science, Hezarjrib Stret, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-09-21, 1396/06/30
Ethics committee reference number
IR.MUI.MED.REC.1397.245
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache severity
Timepoint
Two weeks, one month, three months after begining of treatment
Method of measurement
Pediatric Migraine Disability Assessment Scale
2
Description
Headache frequency
Timepoint
Two weeks, one month, three months after begining of treatment
Method of measurement
interview
3
Description
Headache duration
Timepoint
Two weeks, one month, three months after begining of treatment
Method of measurement
Interview
Secondary outcomes
1
Description
Medication side effects
Timepoint
Two weeks, one month, three months after begining of treatment
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: In this group, patients are treated with 50 mg/kg L-carnitine daily.
Category
Treatment - Drugs
2
Description
Intervention group: In this group, patients are treated with 1 mg/kg Propranolol daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Omid Yaghini
Street address
Imam Hossein Hospital, Imam Khomeini street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
Yaghini@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Omid Yaghini
Street address
Amin Hospital, Ebne Sina Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3445 5051
Email
Yaghini@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou javanmard
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?