Phase IIb clinical trial of steroid therapy in patients with HAM

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000023798
• Date of registration: 31/08/2016
• Prospective Registration: Yes
• Primary sponsor: St. Marianna University School of Medicine Hospital
• Public title: Phase IIb clinical trial of steroid therapy in patients with HAM
• Scientific title: Phase IIb clinical trial of steroid therapy in patients with HAM - HAMLET-P
• Date of first enrolment: 2016/08/31
• Target sample size: 8
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027409
• 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: (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

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)

Following to administrate Methylprednisolone 1000mg/day intravenously slowly for consecutive three days, Prednisolone is administered orally for a maximum dose in 0.5mg/kg/day, then decreased gradually and terminated. There is a case to maintain the dose of Prednisolone by the degree of a progress of underlying disease.
Prednisolone is administered orally for a maximum dose in 0.5mg/kg/day, then decreased gradually and terminated. There is a case to maintain the dose of Prednisolone by the degree of a progress of underlying disease.

Primary Outcome(s)

Efficacy:Presence or absence of 30% or more improvement in a walking time of 10-meter walk test or one grade or more improvement in OMDS at 15 days compared with baseline level.

Secondary Outcome(s)

Efficacy: -A walking time of 10-meter walk test. 1. Presence or absence of 30% or more improvement in a walking time of 10-meter walk test. 2. An area under the curve from at 15 days and 29 days (4 weeks) compared with baseline level. 3. A variation at 15 days and 29 days (4 weeks) compared with baseline level. -A walking distance for 2 or 6 minutes. 1. An area under the curve from at 15 days and 29 days (4 weeks) compared with baseline level. 2. A variation at 15 days and 29 days (4 weeks) compared with baseline level. -OMDS. Presence or absence of one grade or more improvement in OMDS at 15 days compared with baseline level. -A neopterin concentration in cerebrospinal fluid. A variation at 15 days compared with baseline -A ratio of subjects treated the Methylprednisolone pulse therapy from 29 days (4weeks) to 169 days (24 weeks).

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: 14/07/2016
Contact:

Results

• Results available: Yes
• Date Completed: 31/03/2020