Comparison of the effects of Pramipexole and Gabapentin on the treatment of restless leg syndrome in end-stage chronic renal failure patients undergoing hemodialysis
Evaluate the effects of pramipexole and gabapentin on the treatment of RLS in chronic renal failure patients undergoing hemodialysis
Design
Sixty eligible patients are divided into two groups according to the random number table. Patients in the first group are treated with pramipexole and the second group is treated with gabapentin for 4 weeks.
Settings and conduct
In this clinical trial, all chronic renal failure patients undergoing permanent dialysis in the dialysis ward of two hospitals in Bu Ali Sina and Velayat in Qazvin city who have moderate to severe RLS using IRLSSG diagnostic criteria are included . They were randomly divided into pramipexole and gabapentin groups and treated for 4 weeks.
Participants/Inclusion and exclusion criteria
Patients with end-stage chronic renal failure (at least 6 months), under permanent hemodialysis, and with moderate to severe RLS based on IRSLSS diagnostic criteria
Intervention groups
1 - Treatment with pramipexole 0.18 mg daily for 4 weeks
2- Treatment with gabapentin 100 mg daily for 4 weeks
Main outcome variables
The effect of drug use on the severity of RLS based on IRLSSG diagnostic criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045350N1
Registration date:2019-11-23, 1398/09/02
Registration timing:retrospective
Last update:2019-11-23, 1398/09/02
Update count:0
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Sepideh Hajian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 3824
Email address
s.hajian@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-03-20, 1397/12/29
Scientific title
Comparison of the effects of Pramipexole and Gabapentin on the treatment of restless leg syndrome in end-stage chronic renal failure patients undergoing hemodialysis
Public title
Comparison of the effects of Pramipexole and Gabapentin on the treatment of restless leg syndrome in patients undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with end-stage chronic renal failure (at least 6 months) under permanent hemodialysis
Having restless legs syndrome (RLS) based on International RLS Study Group (IRSLSS) diagnostic criteria
Moderate to severe RLS based on IRSLSS diagnostic criteria
Exclusion criteria:
Pregnancy
Iron deficiency anemia
Concomitant neurodegenerative diseases such as cerebrovascular accident (CVA) and Parkinson's disease
Lyme disease
Complications such as nausea, vomiting, and abdominal pain due to medication use
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using a random number table, with odd numbers assigned to the pramipexole group and even numbers to the gabapentin group.
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 Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2017-06-13, 1396/03/23
Ethics committee reference number
IR.QUMS.REC.1396.167
Health conditions studied
1
Description of health condition studied
Restless legs syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
Primary outcomes
1
Description
Disease severity
Timepoint
Before the study and after 4 weeks of treatment
Method of measurement
Severity scale based on International Restless Legs Syndrome Study Group (IRSLSS) diagnostic criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pramipexole 0.18 mg daily for 4 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Gabapentin 100 mg daily for 4 weeks