In this study two hundred patients with migraine headaches according to international headache society criteria are assigned randomly in two groups equally. All patients are selected between eighteen to forty five years old with at least one year history of migraine headache and at least three attacks in each month. One group take nortriptiline twenty five milligrams each night for three months and another group takes venlafaxine 37.5 milligrams two times daily at noon and night equal to seventy five milligrams daily for the same duration. Frequency of attacks in month, duration of attacks in hour and headache intensity is measured by Visual analogue scale (VAS) and six points behavioral rating scale (BRS-6) . All patients are evaluated in the beginning,after forty five and ninty days after taking the drugs. Patients with another kind of headaches, other neurologic problems, taking drugs other than migraine drugs, or any history of allergy or hypersensitivity to drugs which are used in study are not permitted.Patients and investigators and persons who analyse data in primary and middle stages of study are not aware of the intervention or drug types used by patients.All patients have written informed consent by supervision of ethical committee of Shahed University and can leave the study each time during it.
General information
Acronym
Venlafaxine in Migraine
IRCT registration information
IRCT registration number:IRCT2017052930680N3
Registration date:2017-10-09, 1396/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-09, 1396/07/17
Registrant information
Name
Siamak Afshinmajd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9438
Email address
afshin@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-01-10, 1393/10/20
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of The Effects Of Venlafaxine And Nortriptiline on Prevention of Migraine Headaches
Public title
The Effect of Venlafaxine on Prevention of Migraine Headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Migraine headache according to international headache society
Age between eighteen to forty -five years old
At least three attacks of headaches each month with more than four hours duration
At least one year duration of headache attacks
Exclusion Criteria:
Any other type of headaches such as tension, cluster,..
Other neurologic problems such as vertigo,vascular disorders, Parkinson,...
Use of any other type of drugs,except drugs used in migraine headaches
Any history of unwantedreaction or hypersensitivity to drugs in the study
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
201
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study patients who come to clinic randomly and every other one are assigned in the groups using Nortriptiline or Venlafaxine. The first group is selected by drawing lot.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Shahed University
Street address
Entrance of Tehran - Qom Highway
City
Tehran
Postal code
Approval date
2014-03-18, 1392/12/27
Ethics committee reference number
Shahed.REC.1392.47
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine(Idiopathic)common
2
Description of health condition studied
Migraine
ICD-10 code
G43.1
ICD-10 code description
Migraine (Idiopathic) classical
Primary outcomes
1
Description
Headache Intensity
Timepoint
At the beginning, after forty five and ninty days
Method of measurement
Visual Analougue Scale
2
Description
Headache Intensity
Timepoint
At the beginning, after forty five and ninty days
Method of measurement
6 Points Behavioral Rating Scale
3
Description
Frequency of headache attacks
Timepoint
At the beginning, after forty five and ninty days
Method of measurement
Number of headache attacks in one month
4
Description
Duration of headache attacks
Timepoint
At the beginning, after forty five and ninty days
Method of measurement
Average duration of headache attacks in hour according to patients expressions
Secondary outcomes
1
Description
Pruritus, Burning sensation and Redness of skin
Timepoint
Immediately after patient alarm
Method of measurement
Observation, examination and consultation with proper specialist
Intervention groups
1
Description
Group one:
All patients take nortriptiline twenty five(25) milligrams at night for three months
Category
Treatment - Drugs
2
Description
Group Two:
all patients take thirty - seven and half milligrams (37.5) at noon at the same amount at night for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Siamak Afshinmajd
Street address
keshavarz bld. Italia street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahed University
Full name of responsible person
Zahra Kiasalari
Street address
Entrance of Tehran -Qom Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?