Evaluating the therapeutic effects of Dalfampridine on the gait disorders in patients with HTLV-1-induced myelopathy
Design
A phase 3, triple-blinded, controlled clinical trial with two parallel-group designs of 40 patients
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 analyzers will be unaware of the study groups.(HTLV-1 Clinic)
Participants/Inclusion and exclusion criteria
Patients with HTLV-1-induced myopathy who has passed less than 15 years of onset symptoms
Intervention groups
Intervention group: Oral administration of one 10-mg Dalfampridine capsule daily for 2 months.
Control group: Oral administration placebo (the same capsule regarding color and shape compared to the intervention group) for 2 months.
Main outcome variables
The measures of MRC (muscle strength); Ashworth (spasticity); OMDS (motor disability); UDS (urinary tract disorder); T25FW:Timed 25 foot
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180618040127N4
Registration date:2023-06-08, 1402/03/18
Registration timing:prospective
Last update:2023-06-08, 1402/03/18
Update count:0
Registration date
2023-06-08, 1402/03/18
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
2023-06-21, 1402/03/31
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Dalfampridine on dysfunction of walking in patients with HTLV-1-induced myelopathy
Public title
The effect of Dalfampridine in HTLV-1 patients
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
Receiving other drug which influence immune system
Existence of any history of seizures or epilepsy or other seizure disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
40
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 numbers from one to forty.
These numbers are defined as placebo and main drug in the pre-prepared tables with the main analyzer.
In addition, the numbers and medicines have been randomly drawn by the main analyzer.
we have 40 patients that are divided into two groups(ie, pill drug and placebo) thus we select 40 numbers (ie, 01to 40) witch 20 belong to cases and 20 numbers belong to control. we write the name case or control on the paper and put on of them into an open box and 40 patients incidentally pick 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 01 to 40 and delivered to the main analyzer. At the end of the study, these numbers 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)