Evaluating the safety and therapeutic effects of Teriflunomide on clinical symptoms, inflammatory and viral factors in patients with HTLV-1-induced myelopathy
Design
A phase 3, triple-blinded, controlled clinical trial with two parallel group desgin of 22 patients in a single center
Settings and conduct
The study will be performed at the Department of Neurology at Ghaem Hospital in Mashhad. Patients will be blinded with placebo and outcome assessors and data analyser will be unaware of study groups.(HTLV-1 Clinic)
Participants/Inclusion and exclusion criteria
Inclusion criteria are patient with HAM/TSP with moto disability under MDG score of nine.
Exclusion criteria are patient with other autoimmune disorders comorbidity and patient under treatment with immunosuppressive drugs.
Intervention groups
Intervention group: Oral administration of one 14-mg Teriflunomide tablet daily for 12 months
Control group: Oral administration placebo (the same tablet regarding colour and shape compared to the intervention group) for 12 months
Main outcome variables
Serum levels of TNF-a, NFL;
Viral load levels;
The measures of MRC (muscle strength); Ashworth (spasticity); OMDS (motor disability); UDS (urinary tract disorder);
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180618040127N3
Registration date:2021-11-19, 1400/08/28
Registration timing:registered_while_recruiting
Last update:2021-11-19, 1400/08/28
Update count:0
Registration date
2021-11-19, 1400/08/28
Registrant information
Name
Zohreh Vahidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 9828
Email address
vahidizh3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Teriflunomide’s safety and effect on clinical signs, inflammatory and viral factors in patients with HTLV-1-induced myelopathy
Public title
The safety and effect of Teriflunomide in patients with HTLV-1-induced myelopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive serology for Human T-cell Lymphotropic Virus Type-1 (HTLV-1)
Occurrence of spastic paraparesia
Existence of anti HTLV-1 antibody in cerebrospinal fluid
Rule out of other etiologies of spastic paraparesia
Motor Disability Grading (MDG) less than 9
Informed consent for participating in the study
Exclusion criteria:
Existence of other active and latent infections include of old or active tuberculosis or hepatitis
Receiving other drug which influence immune system
Severe renal dysfunction
Married women of childbearing age who do not use safe contraception
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Depending on the time of arrival of patients in the study, the patient randomly selects one of the letters of the English alphabet from A to V.
These letters are defined as placebo and main drug in the pre-prepared tables with the main analyzer.
In addition, the order of English letters and medicines has been randomly drawn by the main analyzer.
we have 22 patients that divided into two groups(ie, pill drug and placebo) thus we select 22 English alphabetic words (ie, A to V) witch 11 words belong to cases and 11 words belong to control. we write the name case or control on the paper and put on of them into an open box and 22 patients incidentally pick of them and they don't see the result and they give that paper to us.
Blinding (investigator's opinion)
Triple blinded
Blinding description
According to the explanations given in the way of randomization and with the coordination of the drug manufacturer, the coating and packaging form of the placebo and the drug are considered the same and are coded as A to V and delivered to the main analyzer. At the end of the study, these letters of the alphabet a to v are decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of َMashhad University of Medical Sciences
Street address
Opposite Daneshgah 18, Daneshgah Avenue, Central bulding of Mashhad University of Medical Sciences (Ghoreishi)
Serum level of inflammatory cytokines (TNF-a and NFL) and Viral load
Timepoint
At the begging of study and 12 months later
Method of measurement
Serum level evaluation
Secondary outcomes
1
Description
Medical Research Council (MRC) Scale for Muscle Strength
Timepoint
At the begging of study and months of three, six, nine and twelve
Method of measurement
Physical examination
2
Description
Spasticity score with Ashworth scale
Timepoint
At the begging of study and months of three, six, nine and twelve
Method of measurement
Physical examination
3
Description
Motor Disability score with Osame Motor Disability Score
Timepoint
At the begging of study and months of three, six, nine and twelve
Method of measurement
Physical examination
4
Description
Urinary disturbance score
Timepoint
At the begging of study and months of three, six, nine and twelve
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Daily administration of one 14-mg tablets of Teriflunomide for 12 months. The drug company is Dr. Abidi.
Category
Treatment - Drugs
2
Description
Control group: Daily administration of one placebo (tablet in same color and shape with intervention group) for 12 months. The placebo company is Dr. Abidi.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
Dr. MohammadAli Nahayati
Street address
Ahmad abad Street, before Shariati Square. Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3842 9828
Email
Nahayatia@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Oposite Daneshgah 18 Street, Daneshgah Street, Central Bulding of Mashhad University of Medical Sciences (Ghoreishi)
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. MohammadAli Nahayati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Before Shariati Square, Ahmadabad Street, Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3842 9828
Email
Nahayatia@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. MohammadAli Nahayati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Before Shariati Square, Ahmadabad Street, Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3842 9828
Email
nahayatia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. MohammadAli Nahayati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Before Shariati Square, Ahmadabad Street, Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3842 9828
Email
Nahayatia@mums.ac.ir
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
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
I haven't decided yet - the release schedule is still unknown
When the data will become available and for how long
I haven't decided yet - the release schedule is still unknown
To whom data/document is available
I haven't decided yet - the release schedule is still unknown
Under which criteria data/document could be used
I haven't decided yet - the release schedule is still unknown
From where data/document is obtainable
I haven't decided yet - the release schedule is still unknown
What processes are involved for a request to access data/document
I haven't decided yet - the release schedule is still unknown