DDrare: Database of Drug Development for Rare Diseases

Searched query = "HTLV-1-associated myelopathy", "Tropical spastic paraparesis", "HTLV-1", "HTLV-I-associated myelopathy"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = Amniotic Epithelial Cells; Amniotic epithelial cells; Bortezomib; Ciclosporin; Costicosteroids; Cyclophosphamide; Doxorubicin; Doxorubicin Hydrochloride; Doxorubicin hydrochloride; Etoposide; Filgrastim; Hu MiK-Beta-1; Human interferon beta; Interferon alfa; Interferon beta; Interferon beta-1a; KW-0761; KW-0761 0.3 mg/kg IV; Lamivudine; Lenalidomide; Methylprednisolone; Mogamulizumab; NK Cells; NK cells; Nivolumab; Other: Laboratory Biomarker Analysis; Other: Pharmacogenomic Study; Pentosan polysulfate; Pentoxifylline; Prednisolone; Prednisone; Propantheline; Propantheline Bromide; Raltegravir; Raltegravir and Zidovudine; Recombinant human interferon beta-1a; Recombinant interferon alfa; Sulfate; Tamibarotene; Valproic acid; Valproid acid plus corticosteroids; Vincristine; Vincristine Sulfate; Vincristine sulfate; Zidovudine; Zidovudine/lamivudine

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-UMIN000024086	2016/09/16	20/09/2016	Phase IIb clinical trial of steroid therapy in patients with HAM(Non progressor)		HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)	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.	St. Marianna University School of Medicine Hospital	NULL	Recruiting	18years-old	Not applicable	Male and Female	5	Phase 2b	Japan
2	JPRN-UMIN000023798	2016/08/31	31/08/2016	Phase IIb clinical trial of steroid therapy in patients with HAM		HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)	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.	St. Marianna University School of Medicine Hospital	NULL	Recruiting	18years-old	Not applicable	Male and Female	8	Phase 2;Phase 3	Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-UMIN000024086

2016/09/16

20/09/2016

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

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

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.

St. Marianna University School of Medicine Hospital

NULL

Recruiting

18years-old

Not applicable

Male and Female

Phase 2b

Japan

JPRN-UMIN000023798

2016/08/31

31/08/2016

Phase IIb clinical trial of steroid therapy in patients with HAM

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

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.

St. Marianna University School of Medicine Hospital

NULL

Recruiting

18years-old

Not applicable

Male and Female

Phase 2;Phase 3

Japan