Evaluation of the effects of Gluronic acid in HTLV-1 patients

Phase 3

• Conditions: patients with HTLV-1 associated myelopathy.; Human T-cell lymphotrophic virus, type I [HTLV-I] as the cause of diseases classified elsewhere; B97.33

• Registration Number: IRCT20180618040127N1
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 September 2018

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

HTLV-1 positive serology
Symptoms of spastic paraparesis
Presence of anti-HTLV-1 antibody in the cerebrospinal fluid
MDG less than 9
Passing less than 15 years from incidence of disease symptoms
Patient informed consent to participate in the study

Exclusion Criteria

Other causes of spastic paraparesis
receive other drugs that affect the immune system
Existence of other diseases other than HAM / TSP

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medical Research Council (MRC) Scale for Muscle Strength. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination.;Spastisite score with Ashworth scale. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination.;Motor Disability score with Osame Motor Disability Score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination.;Urinary disturbance score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: physical examination and history.;Serum level of inflammatory cytokines (IL-1, IL-6, IL-8 and TNF-a), Proviral load levels. Timepoint: At the begging of study and 12 weeks later. Method of measurement: serum level evaluation.