Efficacy and safety evaluation of oral tapering prednisolone following inravenous methyl prednisolone to improve outcome of multiple sclerosis relapses: A randomized, double-blind, placebo-controlled trial
Determine the efficacy and safety of two regimens in the treatment of acute multiple sclerosis with or without reducing the dose of corticosteroid received to improve the incapacity of MS patients
Design
Randomized double blind clinical trial with placebo control, 70 patients with multiple sclerosis, 1: 1 in each group
Settings and conduct
Bu-Ali Sina Hospital Sari, Patients are randomly assigned into test groups. Until the end of the trial, no patient or investigator are aware of which drug each patient receives. Only one person who is not involved in the sampling and registration of information is aware of the drug code (main drug and Placebo)
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18 years old;
Disability Status Scale (EDSS) 0 to 5.0 before the attack;
Exclusion criteria:
Corticosteroid susceptibility;
Any worsening in symptoms that require a change in treatment;
Patient with optic neuritis;
No complete period of treatment by the patient;
Patients with active and bleeding stomach ulcer;
Patient with diabetes with uncontrolled blood sugar.
Intervention groups
Intervention group: methylprednisolone pulse period (3 to 5 days) + tapering dose of prednisolone 50 mg orally Manufacturing Co. Abureyhan 20 days
Placebo group: methylprednisolone pulse period (3 to 5 days) + tapering dose of prednisolone 50 mg orally Construction Group pharmaceutics School of Pharmacy within 20 days
Main outcome variables
FSS (Functional Systems Scores); ARMS(Assessing Relapse in multiple Sclerosis); Disability Status Scale (EDSS); Patient's weight.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120314009297N6
Registration date:2019-10-13, 1398/07/21
Registration timing:registered_while_recruiting
Last update:2019-10-13, 1398/07/21
Update count:0
Registration date
2019-10-13, 1398/07/21
Registrant information
Name
narjes hendouei
Name of organization / entity
mazandaran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 911 327 0107
Email address
hendoieen@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-30, 1398/04/09
Expected recruitment end date
2020-06-29, 1399/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety evaluation of oral tapering prednisolone following inravenous methyl prednisolone to improve outcome of multiple sclerosis relapses: A randomized, double-blind, placebo-controlled trial
Public title
The effect of tapering of prednisolone after pulse therapy in a MS attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Disability Status Scale (EDSS) 0 to 5.0 before the attack
Exclusion criteria:
Corticosteroid susceptibility
Any worsening in symptoms that require a change in treatment
Patient with optic neuritis
Not complete Period of treatment by the patient
A patient with active and bleeding stomach ulcer
A patient with diabetes with uncontrolled blood sugar
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the method of the permutation blocks of size 4,
individuals are randomly divided into two groups.
Samples will be divided into two experimental and
control groups based on permutation blocks (blocks of
size 4). It will be listed according to six possible ways
(AABB, ABAB, ...) randomly and the arrangement of
receiving intervention will be determined accordingly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Prednisolone and placebo tablets are completely similar in terms of color, size, smell and taste, produced by a completely similar manufacturing and packagings. Until the end of the study, no patient or researcher are aware of which drug each patient receives. Only one person who is not involved in sampling and data gathering is aware of the drug codes (medication or placebo)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moallem Street, Moallem Square, Vice Chancellor For Research
City
Sari
Province
Mazandaran
Postal code
33971-48157
Approval date
2019-06-17, 1398/03/27
Ethics committee reference number
IR.MAZUMS.REC.1398.570
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
EDSS (Expanded Disability Status Scale)and FSS(Functional Systems Scores) assessments that sustained increase in EDSS is considered as a change in measure from the start of the study. These two measures ultimately assess the incapacity of the MS and the course of the disease after receiving treatment.
Timepoint
The first month and the third month
Method of measurement
FSS, EDSS scale
Secondary outcomes
1
Description
Pulse methylprednisolone followed by oral prednisone Safety Assessment
Timepoint
The end of the first month
Method of measurement
Check list ARMS (assessment of relapse in multiple Sclerosis)
Intervention groups
1
Description
Intervention group: 1000 mg iv methylprednisolone for 5 days, followed by 50 mg oral prednisolone for 5 days, then 3/4 of prednisolone 50 mg for 5 days, then 1/2 prednisolone 50 mg for 5 days, then 1/4 mg prednisolone 50 mg for 5 days
Category
Treatment - Drugs
2
Description
Control group: 1000mg of methylprednisolone for 5 days, followed by 50 mg of oral placebo for 5 days, then 3/4 mg of the drug for 5 days, then 1/2 of the placebo for 5 days, then 1/4 mg of the drug for 5 Day (a total of 20 days, the placebo dose is reduced and discontinued)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Sina Hospital
Full name of responsible person
Narjes Hendouei
Street address
pasdaran Blvd.Bu-Ali Sina Medical Education Center
City
sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3348
Email
Hendoieen@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Moallem Street, Moallem Square-Vice Chancellor For Research
City
ُSari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3326 1245
Email
tmaae@liv.ac.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narjes Hendouei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
20th Km Farahabad Road, Payambar Azam Academic Complex
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
hendoieen@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narjes Hendouei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
20th Km Farahabad Road, Payambar Azam Academic Complex Sari
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
hendoieen@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narjes Hendouei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
20th Km Farahabad Road, Payambar Azam Academic Complex
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
hendoieen@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I have not decided yet - its release plan is still unclear