Objectives: To assess the effect of promipexol versus no treatment in migraine patients with restless leg syndrome.
Design: a before after clinical trial.
Setting and conduct: The eligible migraine patients who will refer to Farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) The frequency of headache at least 4 times a month; (b) headache leads to dysfunction.
Exclusion criteria: (a) breastfeeding and pregnancy; (b) contraindication of promipexol.
Intervention group: Routine treatment plus promipexol 18 mg (on fourth of tablet) once a night and then increasing the dose gradually to a maximum of one tablet every night for 3 months.
Control group: In comparison with before treatment.
Primary outcome: Assessing the frequency of headache one, two, and three months after treatment using questionnaire.
Secondary outcome: (a) assessing the nausea and vomiting one, two, and three months after treatment using questionnaire; (b) assessing the insomnia one, two, and three months after treatment using questionnaire; (c) assessing the dizziness one, two, and three months after treatment using questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506019014N63
Registration date:2015-06-06, 1394/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-06, 1394/03/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of promipexol versus no treatment in migraine patients with restlessleg syndrome: a before after clinical trial
Public title
Effect of promipexol versus no treatment in migraine patients with restlessleg syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) The frequency of headache at least 4 times a month; (b) headache leads to dysfunction.
Exclusion criteria: (a) breastfeeding and pregnancy; (b) contraindication of promipexol.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: This is a before after trial without randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-04-11, 1394/01/22
Ethics committee reference number
D/P/16/35/9/42
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Assessing the frequency of headache
Timepoint
one, two, and three months after treatment .
Method of measurement
using questionnaire
Secondary outcomes
1
Description
assessing the dizziness
Timepoint
one, two, and three months after treatment
Method of measurement
using questionnaire
2
Description
assessing the insomnia
Timepoint
one, two, and three months after treatment
Method of measurement
using questionnaire
3
Description
assessing the nausea and vomiting
Timepoint
one, two, and three months after treatment
Method of measurement
using questionnaire
Intervention groups
1
Description
In comparison with before treatment
Category
N/A
2
Description
Routine treatment plus promipexol 18 mg (on fourth of tablet) once a night and then increasing the dose gradually to a maximum of one tablet every night for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Afshin Afshari
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Farshchian Hospital
Full name of responsible person
Afshin Afshari
Position
Medical Student
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
afsharafshin68@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Mehrdokh Mazdeh
Position
Neurologist
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
mazdeh@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)