Restles Legs syndrome is one of the sleep disorders that have variables causes including: Iron deficiency anemia,pregnancy,Uremia,idiopatic , etc. RLS is common in uremic patient. In this study we are going to compare the efficacy of gabapentin versus levodopa-c in hemodialysis patients in hemodialysis center of Kermanshah Emam Reza hospital. Inclusion criteria for patients is fulfilling 4 criteria of IRLSSG (International Restless Legs Syndrom Study group) which indicate moderate to severe RLS.The patients will evaluate for pregnancy and some other causes of RLS As exclusion criteria. The patients will evaluated in three stages. At first for 4 wks they treated by Gabapentin , the second stage is 2 wks washout and the third stage is 4 wks treatment by levodopa -C.For evaluation of effect of each drug we evaluate the patients with IRLSSG scale , SF-36 (scale of evaluation of quality of life),Pittsburg sleep quality index (PSQI)and Epworth sleepiness scale (ESS)before and after drug administration. Hb, TIBC, ferittin and serum iron also will be ckeked for control and comparison.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112078323N1
Registration date:2012-01-15, 1390/10/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-15, 1390/10/25
Registrant information
Name
Nazanin Razazian
Name of organization / entity
Neurology Department of Kermanshah Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 3409
Email address
nrazazian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pro_vice_chancellor for research of Kermanshah University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of therapeutic effects of Gabapentin versus Levodopa-c on Restless legs syndrome in hemodialysis patientes
Public title
Comparative study of therapeutic effects of Gabapentin versus Levodopa-c on Restless legs syndrome in hemodialysis patientes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :minimal time of hemodialysis : 3 mount ؛IRLSSG scale more than 10؛ Patient`s age more than 15 years
Exclusion criteria: Under treatment with psychotropic agents during recent 2 weeks؛presence of another neurologic disease comorbid with ESRD for example CVA, MS and etc.؛Iron deficiency anemia؛Pregnancy
Age
From 15 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Science and Health Services
Street address
Shahid Beheshti ave. Kermanshah
City
Kermanshah
Postal code
Approval date
2011-11-16, 1390/08/25
Ethics committee reference number
7/420/پ
Health conditions studied
1
Description of health condition studied
RLS: Restless Legs syndrome.
ICD-10 code
G 25.8
ICD-10 code description
Other specified extrapyramidal and movement disorders
Primary outcomes
1
Description
severity of RLS
Timepoint
At first &4 wks after first drug administration before second drug administration & 4 wks after second drug administration (end of the study)
Method of measurement
with IRLSSG scale
2
Description
severity of sleep disorder
Timepoint
At first &4 wks after first drug administration before second drug administration & 4 wks after second drug administration (end of the study)
Method of measurement
with pittsburg sleep quality index
3
Description
quality of life
Timepoint
At first &4 wks after first drug administration before second drug administration & 4 wks after second drug administration (end of the study)
Method of measurement
with SF-36 (scale of quality of life)
4
Description
day time sleepiness
Timepoint
At first &4 wks after first drug administration before second drug administration & 4 wks after second drug administration (end of the study)
Method of measurement
Epworth sleepiness scale
Secondary outcomes
1
Description
drug advers reaction
Timepoint
At first &4 wks after first drug administration before second drug administration & 4 wks after second drug administration (end of the study)
Method of measurement
with question from patients
Intervention groups
1
Description
capsules of gabapentin 200 mg after evry hemodialysis for 4wks 2hours befor sleep