Phase IIb clinical trial of steroid therapy in patients with HAM(Slow progressor) - HAMLET-P

St. Marianna University School of Medicine Hospital0 sites40 target enrollmentSeptember 20, 2016

ConditionsHTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)
Sponsor: St. Marianna University School of Medicine Hospital
Enrollment: 40
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 20, 2016

End Date

March 31, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

St. Marianna University School of Medicine Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•(2\)Patients defined as slow or non\-progressor who have received corticosteroids or other treatment targeted to HAM within 48 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 received live or attenuated/inactivated vaccines within four weeks prior to giving informed consent or plan to receive those during the study period (6\)Patients who have received 1\.5g/day or more of ascorbic acid, prosultiamine, or pentosan polysulfate within two weeks prior to 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 complications (10\)Patients with uncontrolled hypertension (11\)Patients with uncontrolled electrolyte imbalance (12\)Patients with thrombosis (13\)Patients with cancer or a history of cancer (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 with compressive spinal cord lesions such as osteoarthritis of the spine, ossification of posterior longitudinal ligament and ossification of yellow ligament, or joint diseases such as rheumatoid arthritis and osteoarthritis, which preclude assessment using the walk tests or can be worsened by the walk tests (20\)Patients with neurological deficits or findings on MRI suggesting it due to disorders other than HAM