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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000024085
• Date of registration: 20/09/2016
• Prospective Registration: No
• Primary sponsor: St. Marianna University School of Medicine Hospital
• Public title: Phase IIb clinical trial of steroid therapy in patients with HAM(Slow progressor)
• Scientific title: Phase IIb clinical trial of steroid therapy in patients with HAM(Slow progressor) - HAMLET-P
• Date of first enrolment: 2016/09/16
• Target sample size: 40
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027727
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Phase II,III

Countries of recruitment

Japan

Contacts

• Name: Ushitani,Kuwahara
• Affiliation: HAMLET-P Coordinating Center Clinical Research Data Center,St. Marianna University School of Medicine

• Name: Yoshihisa Yamano M.D.,Ph.D.
• Affiliation: St. Marianna University School of Medicine Hospital Department of Neurology

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 18years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Prednisolone is orally administered at a maximum dose of 0.5mg/kg/day and then tapered to a maintenance dose of 5mg/day.
Indistinguishable placebo is orally administered for 24 weeks, and then 5mg/day of prednisolone for the next 24 weeks.

Primary Outcome(s)

Efficacy: Change in walking time as measured by 10-meter walk test from baseline to Day 169 (Week 24)

Secondary Outcome(s)

Efficacy: <Prednisolone group versus control group> -Walking time measured by 10-meter walk test Change in the time from baseline to Day 29 (Week 4) and Day 85 (Week 12) -Distances walked over two minutes as well as six minutes Change in the distances from baseline to Day 29 (Week 4), Day 85 (Week 12) and Day 169 (Week 24) - Cerebrospinal fluid neopterin concentration Change in the concentration from baseline to Day 169 (Week 24) -Discontinuation rate of the study drug during the period of treatment with the study drug (Day 1 to Day 169 [Week 24]) <Comparison in the control group> Walk tests (Walking time in 10-meter walk test and distances walked over two and six minutes) Comparison of changes in the results from baseline to Day 169 (Week 24) with those from Day 169 (Week 24) to Day 337 (Week 48) -Cerebrospinal fluid neopterin concentration Comparison of change in the concentration from baseline to Day 169 (Week 24) with that from Day 169 (Week 24) to Day 337 (Week 48) -Safety Adverse event (incidence and severity)

Source(s) of Monetary Support

The Research on Measures for Intractable Diseases Project of Japan Agency for Medical Research and Development

Ethics review

Status: YES
Approval date: 19/08/2016
Contact:

Results

• Date Completed: 31/03/2020