Phase IIb clinical trial of steroid therapy in patients with HAM

Phase 2

• Conditions: HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)

• Registration Number: JPRN-UMIN000023798
• Lead Sponsor: St. Marianna University School of Medicine Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-31
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Patients who have received corticosteroids or other treatment targeted to HAM within 12 weeks prior to giving informed consent (3)Patients who have undergone invasive surgeries requiring general anesthesia within 24 weeks prior to giving informed consent (4)Patients who have participated in other treatment studies within 16 weeks prior to giving informed consent (5)Patients who have undergone live or attenuated/inactivated vaccinations within four weeks of giving informed consent, or who plan to be vaccinated during the course of the study. (6)Patients taking the ascorbic acid more than 1.5g/day, prosultiamine, or pentosan polysulfate within two weeks of giving informed consent. (7)Patients with a history of acute myocardial infarction (8)Patients with a history of tuberculosis or with active tuberculosis (9)Patients with serious complicating conditions (10)Patients with uncontrolled hypertension (11)Patients with uncontrolled electrolyte imbalance (12)Patients with thrombosis (13)Patients with a history of cancer with complications (14)Patients with peptic ulcer (15)Patients with ATL (16)Patients with poorly controlled eye disease (17)Patients with a history of steroid-induced glaucoma (18)Pregnant or breastfeeding women or patients who may become pregnant or withhold assent to prevention of conception by taking appropriate approach such as condom in cooperation with their partners during the study period (19)Patients in whom assessment with the walk test is difficult or the symptoms can be worsened by the walk test (20)Patients with neurological deficits or findings on MRI suggesting it due to disorders other than HAM

Study & Design

• Study Type: Interventional
• Study Design: Not specified