UMIN-CTR Clinical Trial

Basic information
Public title	Phase IIb clinical trial of steroid therapy in patients with HAM(Non progressor)
Acronym	HAMLET-P
Scientific Title	Phase IIb clinical trial of steroid therapy in patients with HAM(Non progressor)
Scientific Title:Acronym	HAMLET-P
Region	Japan

Condition
Condition	HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore prognostic factors for clinical progression and determinants of differential progression in patient with HAM
Basic objectives2	Others
Basic objectives -Others	To explore prognostic factors and determinants of differential progression
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To explore prognostic factors and determinants of differential progression
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Drugs which possibly affect assessment in the study (e.g. methylprednisolone, prednisolone and other agents targeted to HAM) will be forbidden or limited until Week 48 and periodic evaluation and tests will be performed.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients diagnosed with HAM by reference to the Belem criteria (2006). (2) Patients must have signed an informed consent form at age 18 or older (3) Patients who can walk 10 meters or longer regardless of walking aid use at the time of informed consent. Note, however, that the number of walking stick is not allowed to exceed two and wheeled walker may be used. (4) Patients in whom function of the major organ systems is maintained. (To be confirmed by the most recent laboratory data within 28 days prior to enrollment) 1. Neutrophils: 1500/mm3 or more 2. PLT: 100,000/mm3 or more 3. Hb : 9.0 g/dL or more 4. AST: three times the upper limit of the institutional reference value or lower 5. ALT: three times the upper limit of the institutional reference value or lower 6. Serum creatinine: one and a half times the upper limit of the institutional reference value or lower 7. HbA1c: 6.5 percent or less (5) Patients or their legal guardians must voluntarily give written informed consent to participate in the study (6) Patients who are able and willing to visit the hospitals in line with the study schedule to receive treatment and for follow-up
Key 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
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshihisa Yamano M.D.,Ph.D.
Organization	St. Marianna University School of Medicine Hospital
Division name	Department of Neurology
Zip code
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
TEL	044-977-8111
Email	yyamano@marianna-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ushitani,Kuwahara
Organization	HAMLET-P Coordinating Center
Division name	Clinical Research Data Center,St. Marianna University School of Medicine
Zip code
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL	044-977-8111(6191)
Homepage URL
Email	mariadc_ham@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine Hospital
Institute
Department

Funding Source
Organization	The Research on Measures for Intractable Diseases Project of Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	聖マリアンナ医科大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 03 Day
Date of IRB	2016 Year 07 Month 14 Day
Anticipated trial start date	2016 Year 09 Month 16 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 16 Day
Last modified on	2022 Year 03 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027728