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The effect of Dalfampridine in HTLV-1 patients

The effect of Dalfampridine on dysfunction of walking in patients with HTLV-1-induced myelopathy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180618040127N4
Enrollment
40
Registered
2023-06-08
Start date
2023-06-21
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) patients. Tropical spastic paraplegia

Interventions

Intervention 1: Intervention group: Daily administration of two10-mg capsules ofDalfampridine for 2 months. The drug company is Zahravi,. Intervention 2: Control group: Control group: Daily administra

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Medical Research Council (MRC) Scale for Muscle Strength. Timepoint: At the begging of study and months of 1 and 2. Method of measurement: Physical examination.;Spasticity score with Ashworth scale. Timepoint: At the begging of study and months of 1 and 2. Method of measurement: Physical examination.;Motor Disability score with Osame Motor Disability Score. Timepoint: At the begging of study and months of 1 and 2. Method of measurement: Physical examination.;T25FW:Timed 25 foot walk. Timepoint: At the begging of study and months of 1 and 2. Method of measurement: Physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Reza Boostani

Mashhad University of Medical Sciences

Boostanir@Mums.ac.ir+98 51 3842 9828

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026