Evaluation effect of Propranolol and Pramipexole compared with Propranolol and placebo on treatment of Migrain headache in patients with Migraine and restless legs syndrome at the same time in patient referred to neurology clinic of Ahwaz Golestan hospital
Objectives: Evaluation effect of Pramipexole in patients with Migraine and restless legs syndrome at the same time
Design:Double blind randomized clinical trial
Setting and conduct: The severity of RLS( in IRLLG basis), number and severity of Migrain attack, presence or absence of morning headaches and The use of painkillers in the past three months are questioned from patients. Patients will randomly divide into two groups And go under study
Participants: Among patients with headache who Referred to neurology clinic of Ahwaz Golestan hospital, patient who have 15 to 50 years old and confirm their Migrain diagnosis with International Headache Society (IHS) criteria and have no history of treatment and they have symptoms of restless leg syndrome and consent to be enrolled in the study with consider this criteria:
Main inclusion criteria: No pregnant weman؛ No menopause weman ؛No history of Alcohol or substance addiction ؛No history of cardiac block or bradycardia؛No history of second cause for restless legs syndrome
Main exclusion criteria: Patient who stop continuing the study in each reason; Patient who will be menopause or pregnant
Intervention: One group will treat with Propranolol 20 mg twice a day and placebo two hour before sleep time and another group will treat with Propranolol 20 mg twice a day and Pramipexol 0.7 mg two hours before sleep time for three month .
Main outcome measures: severity of Migrain base on Midas questionary
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022026166N1
Registration date:2016-08-31, 1395/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-31, 1395/06/10
Registrant information
Name
Farzaneh Karimian
Name of organization / entity
Ahwaz Jondishapour university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 2442
Email address
karimian.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Ahwaz Jundishapour university of medical science
Expected recruitment start date
2015-08-15, 1394/05/24
Expected recruitment end date
2016-05-13, 1395/02/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of Propranolol and Pramipexole compared with Propranolol and placebo on treatment of Migrain headache in patients with Migraine and restless legs syndrome at the same time in patient referred to neurology clinic of Ahwaz Golestan hospital
Public title
Evaluation effect of Pramipexole in patients with migraine and restless legs syndrome at the same time
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria: No pregnant weman؛ No menopause weman ؛No history of Alcohol or substance addiction ؛No history of cardiac block or bradycardia؛No history of second cause for restless legs syndrome
Main exclusion criteria: Patient who stop continuing the study in each reason; Patient who will be menopause or pregnant
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Morality committee of Ahwaz Jundishapour university of medical science and health services
Street address
Ahwaz Jundishapour university of medical science and health services، Farvardin boulevard، Golestan highway
City
Ahwaz
Postal code
Approval date
2015-08-15, 1394/05/24
Ethics committee reference number
IR.AJUMS.REC.1394.391
Health conditions studied
1
Description of health condition studied
Migrain, restless legs syndrome
ICD-10 code
G43, G26
ICD-10 code description
Migraine, Other extrapyramidal and movement disorders
Primary outcomes
1
Description
Severity of Miigrain
Timepoint
Start and after 3 months
Method of measurement
Midas questionary
2
Description
Severity of restless leg syndrome
Timepoint
Start and after 3 months
Method of measurement
IRLLG questionary
Secondary outcomes
empty
Intervention groups
1
Description
First group will treat with Propranolol 20 mg twice a day and placebo two hour before sleep time for three months .
Category
Treatment - Drugs
2
Description
Second group will treat with Propranolol 20 mg twice a day and Pramipexol 0.7 mg two hours before sleep time for three months .