Therapeutic effect of co-administration of Amantadine and Aspirin on fatigue in patients with multiple sclerosis: a randomized placebo-controlled double-blind study
Fatigue is recognized as one of the most disabling and frequent symptoms of multiple sclerosis (MS). Amantadine appears to have some proven ability to alleviate the fatigue in MS. The aim of this study is to assess the efficacy of co-administration of amantadine and aspirin for the treatment of fatigue in multiple sclerosis. Forty-five ambulatory patients aged 20–50 years with a diagnosis of MS, a stable disability level ≤6 on the Kurtzke extended disability status scale (EDSS), and a mean score ≥4 on the fatigue severity scale (FSS) will eligible for the 6 weeks, a double-blind clinical trial. Intervention group will receive Aspirin, 500 mg oral tablet, once daily for 42 days and Amantadine,100-mg oral capsule, once daily for 42 days. Control group will receive Amantadine, 100-mg oral capsule, once daily for 42 days and oral placebo tablet for 42 days. Efficacy will evaluated by using the FSS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112208430N3
Registration date:2012-01-15, 1390/10/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-15, 1390/10/25
Registrant information
Name
Farhad Iranmanesh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1226 2629
Email address
fpp_farhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Neuroscience Reserch Center of Kerman
Expected recruitment start date
2008-06-19, 1387/03/30
Expected recruitment end date
2009-08-23, 1388/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of co-administration of Amantadine and Aspirin on fatigue in patients with multiple sclerosis: a randomized placebo-controlled double-blind study
Public title
Effect of co-administration of Amantadine and Aspirin on fatigue in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Definite diagnosis of multiple sclerosis; age between 20-50 years; disability scour ≤6 on the extended disability status scale patients; fatigue score ≥4 on the fatigue severity scale. Exclusion criteria: Patients with current or recent (within 2 months ago) use of medications or allergy to asprin or amantadin.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
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
Ethics Committee of Kerman University of Medical Sciences
Street address
Shafa street
City
Kerman
Postal code
Approval date
2007-05-12, 1386/02/22
Ethics committee reference number
1/86/ک
Health conditions studied
1
Description of health condition studied
Multiple scerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Fatigue Severity Scale
Timepoint
Before intervention,30 days after intervention,42days after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Aspirin,500 mg oral tablet, once daily for 42 days and Amantadine,100-mg oral capsule , once daily for 42 days.
Category
Treatment - Drugs
2
Description
Control group:Amantadine,100-mg oral capsule , once daily for 42 days and oral placebo tablet for 42 days .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Akbar Hamzei Moghaddam
Street address
Shafa hospital, Shafa street
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman Neuroscience Reserch Center
Full name of responsible person
Korosh Divsalar
Street address
Jahad street
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman Neuroscience Reserch Center
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
Kerman Neuroscience Research Center
Full name of responsible person
Akbar Hamzei Moghaddam
Position
Professor of Neurology
Other areas of specialty/work
Street address
Jahad street
City
Kerman
Postal code
7618751151
Phone
+98 34 1246 7139
Fax
+98 34 1211 5803
Email
a_hamzehei@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman uiversity of Medical Sciences
Full name of responsible person
Behnaz Sedighi
Position
Associate professor of Neurology
Other areas of specialty/work
Street address
Shafa hospital
City
Kerman
Postal code
7618751151
Phone
+98 34 1211 5780
Fax
+98 34 1211 5803
Email
behnaz_sedigh@gmal.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farhad Iranmanesh
Position
Associate professor of Neurology
Other areas of specialty/work
Street address
Shafa hospital
City
Kerman
Postal code
7618751151
Phone
00893412115780
Fax
+98 34 1211 5803
Email
fpp_farhad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)