Comparison of efficacy of Levetiracetam with Sodium Valproate in the treatment of Chronic Migraine Headache in patients referred to Ahvaz Golestan Hospital
In this study efficacy of Levetiracetam comparison with Sodium Valproate in the treatment of Chronic Migraine Headache and if Levetiracetam had an equivalent or better effect (statistically significant) than sodium valproate in reduction of headache severity,frequency and Midas score or fewer complications, Sodium Valproate can be replaced Levetiracetam .Patients 15 to 50 years old referred to Ahvaz Golestan Hospital Neurologic Clinic that according to the criteria of the International Headache Society (IHS) have chronic migraine headache to be put under study, if not pregnancy and history of liver or kidney disease.Initially, 10 patients were divided into two groups according to the results of the pilot study examined and the final sample size is calculated. The patients were randomized block into 2 groups.One group are given Sodium Valproate of Sanofi company whit Depakine comercial name and the other group are given Levetiracetam of Cobel company with Levebel comercial name for 3 months. At the end of the first and third month after the first dose, patients are seen and the efficacy of treatment based on the headache in frequency, intensity and changes in MIDAS scores by their patients with headache severity grading scale from 0 to 10 is recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015022812781N2
Registration date:2015-03-12, 1393/12/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-12, 1393/12/21
Registrant information
Name
ِِDavood Kashipazha
Name of organization / entity
Ahvaz JodndiShapour University of Medical Sciencs
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
kashi-d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University Of Medical Siences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of Levetiracetam with Sodium Valproate in the treatment of Chronic Migraine Headache in patients referred to Ahvaz Golestan Hospital
Public title
Comparison of efficacy of Levetiracetam with Sodium Valproate in the treatment of Chronic Migraine Headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with chronic migraine headache according to the International Headache Society criteria , (having headache 15 or more days per month with at least 8 days per month fulfilling International Headache Society criteria for migraine for at least 3 months)
in the absence of ongoing medication overuse; Women have a negative pregnancy test and have appropriate contraception during the study period; No history of liver disease and kidney; No headaches other than migraine-like headaches included tension headache,sinus headache disorder,structural or post traumatic headache and Exclusion criteria: The incidence of side effects such as gastrointestinal or any other unwanted side effects caused by drug; Do not use the medication in groups for three consecutive days or a week of intermittent.
Age
From 15 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz University of Medical Siences
Street address
Department of Development Studies, Ahvaz University of Medical Siences, Golestan Blvd.
City
Ahvaz
Postal code
Approval date
2014-06-16, 1393/03/26
Ethics committee reference number
ajums.rec.1393.122
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
2
Description of health condition studied
Migraine
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura [classical migraine]
Primary outcomes
1
Description
MIDAS Score
Timepoint
1 and 3 months after starting treatment
Method of measurement
Based on a standard questionnaire MIDAS
2
Description
Intensity of headache
Timepoint
1 and 3 months after starting treatment
Method of measurement
Pain severity grading scale by the patient with headache severity from grade 0 to 10
3
Description
Frequency of headache
Timepoint
1 and 3 months after starting treatment
Method of measurement
Headache days per month
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:Levebel 500-1000 mg Oral Twice daily for 3 months
Category
Treatment - Drugs
2
Description
Control: Depakine 500-1000 mg Oral Twice daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital Neurologic Clinic
Full name of responsible person
Mehrnoush Siavashi
Street address
Golestan hospital, Farvardin Avenue, Golestan Street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Siences
Full name of responsible person
Seyed Ahmad Hoseiny
Street address
Department of Technology and Research Development, Ahvaz University of Medical Siences, Golestan Blvd.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Siences
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
Ahvaz Golestan Hospital
Full name of responsible person
Mehrnoush Siavashi
Position
Resident of Neurology
Other areas of specialty/work
Street address
Golestan Hospital, Farvardin Avenue, Golestan Street
City
Ahvaz
Postal code
Phone
+98 61 3374 3011
Fax
Email
shoonrhem@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Siences
Full name of responsible person
Davood Kashipazha/Mehrnoush Siavashi
Position
Neurologist/Resident of Neurology
Other areas of specialty/work
Street address
Golestan Hospital, Farvardin Avenue, Golestan Street
City
Avaz
Postal code
Phone
+98 61 3374 3012
Fax
Email
Dakashi47@gmail.com/shoonrhem@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Golestan Hospital
Full name of responsible person
Davood Kashipazha
Position
Neurologist
Other areas of specialty/work
Street address
Golestan Hospital, Farvardin Avenue, Golestan Street
City
Ahvaz
Postal code
Phone
+98 61 3374 3012
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)