The aim of this study was to compare the efficacy of Zonisamide with Topiramate in decreasing the frequency and severity of migraine attacks. A total of 80 patients, recruited from referred migraineurs to our neurology clinic, who met the inclusion criteria, were randomly allocated to group A or B. In group A, the patients received Zonisamide, 50 mg daily that gradually titrated up to 200mg/d while in group B; the patients received Topiramate, 25mg daily that gradually titrated up to 100mg/d. Each patient was followed for 12 weeks and was assessed at the baseline, the fourth and twelfth weeks for the number of attacks, headache severity, need for acute medication, MIDAS score, and adverse effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011075117N1
Registration date:2011-01-28, 1389/11/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-28, 1389/11/08
Registrant information
Name
Vahid Abbasi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
vahid.abbasi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2009-07-08, 1388/04/17
Expected recruitment end date
2010-03-08, 1388/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Zonisamide versus Topiramate in migraine prophylaxis: a double-blind randomized clinical trial
Public title
Comparation the efficacy of zonisamide and topiramate in migraine prophylaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of classic or common migraine that met International Headache Society (HIS) criteria, which is at least one year of past disease, number of migraine attacks at least four times per month and less than 15 times per month, or even when they occur less than four times per month but migraine attacks are very prolonged and debilitating that require preventive treatment, postmenopausal women who pass at least one year of their menopause, negative pregnancy test, using appropriate contraceptive during the study, no consumption of topiramate or Zonisamide
Exclusion criteria: suffering from other than migraine headaches such as tension headaches, periodic headaches and sinusitis, presence of any cause of pain that must be used medications regularly, history of hypersensitivity to topiramate or zonisamide
Age
From 12 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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 Jundishapur University of Medical Sciences
Street address
Golestan street, ahvaz
City
Ahvaz
Postal code
-
Approval date
2009-06-14, 1388/03/24
Ethics committee reference number
1463/20/8/پ
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache frequency
Timepoint
before trial , 1 month and 3 month after trial
Method of measurement
Questionnaire
2
Description
Use of acute medication
Timepoint
before trial , 1 month and 3 month after trial
Method of measurement
Questionnaire
3
Description
Headache severity
Timepoint
before trial , 1 month and 3 month after trial
Method of measurement
Questionnaire
4
Description
MIDAS score
Timepoint
before trial and 3 month after trial
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Drugs complications
Timepoint
before trial, 1 month and 3 months after trial
Method of measurement
Questionnaire
Intervention groups
1
Description
Zonisamide capsule, 50-200 mg once day for 3 months in the intervention group
Category
Treatment - Drugs
2
Description
topiramate tablet 25-100 mg/day BID or twice in day for 3 month in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic in Golestan hospital
Full name of responsible person
Dr Vahid Abbasi
Street address
Golestan hospital, Golestan street, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Research department of Medical School of Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan street, Ahvaz
City
Ahvaz
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Vahid Abbasi
Position
Resident of Neurology
Other areas of specialty/work
Street address
Golestan hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1374 3003
Fax
Email
V.abbasineuro@yahoo.comVahid.Abbasi@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Seyed Ehsan Mohammadiani neghad
Position
Neurologist , Assistant Professor
Other areas of specialty/work
Street address
Golestan hospital, Ahvaz
City
Ahvaz
Postal code
00986113743003
Phone
Fax
Email
ehsan_neuro@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Vahid Abbasi
Position
Resident of neurology
Other areas of specialty/work
Street address
Golestan hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1374 3003
Fax
Email
V.abbasineuro@yahoo.comVahid.Abbasi@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)