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-JMA-IIA00324	29/06/2017	23/01/2018	A Phase 3 Study of KW-0761 (Mogamulizumab) in Subjects with HTLV-1 Associated Myelopathy (HAM)	A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM)	HTLV-1 associated Myelopathy (HAM)	Intervention type:DRUG. Intervention1:KW-0761, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP. Control intervention1:Placebo, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP.	Kyowa Kirin Co., Ltd	NULL	Completed	>=20 YEARS	No Limit	BOTH	52	Phase 3	Japan
2	JPRN-JapicCTI-173608	01/6/2017	06/06/2017	A Phase 3 Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM)	A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM)	HTLV-1 associated Myelopathy (HAM)	Intervention name : KW-0761 INN of the intervention : Mogamulizumab Dosage And administration of the intervention : 0.3 mg/kg, IV	Kyowa Hakko Kirin Co., Ltd.	NULL	complete	20		BOTH	52	Phase 3	NULL
3	NCT03191526 (ClinicalTrials.gov)	May 22, 2017	13/6/2017	A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)	A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Patients With HTLV-1 Associated Myelopathy (HAM)	HTLV-1 Associated Myelopathy	Drug: KW-0761 0.3 mg/kg IV;Drug: Placebo (saline)	Kyowa Kirin Co., Ltd.	NULL	Active, not recruiting	20 Years	N/A	All	66	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-JMA-IIA00324

29/06/2017

23/01/2018

A Phase 3 Study of KW-0761 (Mogamulizumab) in Subjects with HTLV-1 Associated Myelopathy (HAM)

A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM)

HTLV-1 associated Myelopathy (HAM)

Intervention type:DRUG. Intervention1:KW-0761, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP. Control intervention1:Placebo, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP.

Kyowa Kirin Co., Ltd

NULL

Completed

>=20 YEARS

No Limit

BOTH

Phase 3

Japan

JPRN-JapicCTI-173608

01/6/2017

06/06/2017

A Phase 3 Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM)

A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM)

HTLV-1 associated Myelopathy (HAM)

Intervention name : KW-0761
INN of the intervention : Mogamulizumab
Dosage And administration of the intervention : 0.3 mg/kg, IV

Kyowa Hakko Kirin Co., Ltd.

NULL

complete

BOTH

Phase 3

NULL

NCT03191526
(ClinicalTrials.gov)

May 22, 2017

13/6/2017

A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)

A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Patients With HTLV-1 Associated Myelopathy (HAM)

HTLV-1 Associated Myelopathy

Drug: KW-0761 0.3 mg/kg IV;Drug: Placebo (saline)

Kyowa Kirin Co., Ltd.

NULL

Active, not recruiting

20 Years

N/A

All

Phase 3

Japan