To determine and compare the prophylactic effect of venlafaxine and topiramate in patients with chronic migraine
Design
An open-label randomized controlled-trial aiming at comparing the prophylactic effects of venlafaxine vs topiramate on 100 patients with chronic migraine
Settings and conduct
One hundred patients with confirmed diagnosis of chronic migraine will be recruited in this study. Patients will be allocated in two groups (venaflaxine or topiramate) randomly using 4-blocked randomization method. Patients should stop using migraine prophylactic drugs and they will be asked to complete a prospective headache diary in 4 weeks. In titration period one group will receive 37.5 mg/day venaflaxine and another group will receive 25 mg/day topiramate and if it doesn't have any adverse effects, they should add one tablet to the primary dose each week and they will take 2 tablets per day(150 mg venaflaxine and 100 mg topiramate) untile the end of 4 weeks. After titration period (4 weeks), patients will recieve the maximum dosage that they can tolerate for 12 weeks. During 12 weeks patients will recieve headache diary again and They can also take analgesic drugs if they have headache attack and record it in their headache diary.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients who met the ICHD-3 criteria
Age 20-55 years
Exclusion criteria
Taking migraine prophylactic drugs in the last 4 weeks
Suffeing from renal, cardiovascular and liver diseases
Having major depression, bipolar disorder and psychosis
Having hypertension and ocular hypertension
Pregnancy or lactation
Intervention groups
50 migraine patient in venlafaxine group and 50 migraine patient in topiramate group
Main outcome variables
Mean frequency of migraine attacks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120227009157N8
Registration date:2018-07-10, 1397/04/19
Registration timing:registered_while_recruiting
Last update:2018-07-10, 1397/04/19
Update count:0
Registration date
2018-07-10, 1397/04/19
Registrant information
Name
Prof Mansoureh Togha
Name of organization / entity
Neurology department, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 2052
Email address
toghae@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylactic effect of venlafaxine and topiramate in patients with chronic migraine : An open label randomized controlled trial
Public title
Comparison of prophylactic effect of venlafaxine and topiramate in patients with chronic migraine : An open label randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who met the ICHD-3 criteria
Age 20-55 years
Exclusion criteria:
Taking migraine prophylactic drugs in the last 4 weeks
Suffeing from renal, cardiovascular and liver diseases.
Having major depression, bipolar disorder and psychosis
Having hypertension or ocular hypertension
Pregnancy or lactation
Age
From 20 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be randomized to one of the A( venlafaxine) or B(Topiramate) groups using 4 block randomization method. The main researcher and the patients are aware of the type of adminestrated drugs. This is an open label randomized controlled trial.
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 Tehran University of Medical Sciences
Street address
Sina hospital, Imam Khomeini Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Approval date
2017-09-18, 1396/06/27
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.3516
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Number of migraine days
Timepoint
Before intervention and after 12 weeks intervention
Method of measurement
Headache diary
2
Description
Number of migraine attacks
Timepoint
Before intervention and after 12 weeks intervention
Method of measurement
Headache diary
3
Description
Maximum intensity of migraine attacks
Timepoint
Before intervention and after 12 weeks intervention
Method of measurement
Headache diary and Visual Analogue Scale
Secondary outcomes
1
Description
Headache Duration in hours
Timepoint
Before the intervention and after the intervention period(12 weeks)
Method of measurement
Headache diary
2
Description
Responder rate
Timepoint
After the intervention period(12 weeks)
Method of measurement
Headache diary:30-50% decrease in primary endpoints relative to baseline
3
Description
Days of analgesic usage
Timepoint
Before the intervention and after the intervention period(12weeks)
Method of measurement
Headache diary
4
Description
Health care outcomes/quality of life Recommendations
Timepoint
Before the intervention and after the intervention period(12 weeks)
Method of measurement
HIT-6 score
Intervention groups
1
Description
Intervention group: Intervention group will receive 37.5 mg venlafaxine at the beginig of the intervention period and increase does up to 150 mg until 2 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group will receive 25 mg topiramate at the beginig of the intervention period and increase does up to 100 mg until 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Headache clinic, Sina hospital
Full name of responsible person
Prof. Mansoureh Togha
Street address
Sina hopital, Imam Khomeini Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6312 1506
Email
toghae@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs. Bahareh Pourghaz
Street address
Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3610
Email
baharpourghaz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr.Samaneh Haghighi
Position
Neurologist
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1506
Email
haghighi_sa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Mansoureh Togha
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Sina hospital, Hasan Abad Sq., Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1506
Email
toghae@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Mansoureh Togha
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Sina hospital, Hasan Abad Sq., Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1506
Email
toghae@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available