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)
- Conditions
- HTLV-1 Associated Myelopathy (HAM)
- Registration Number
- JPRN-UMIN000029913
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 67
Not provided
1) Any of the following significant concomitant diseases: Type 1 diabetes mellitus, Poorly controlled type 2 diabetes mellitus (HbA1c (NGSP) > 8.5%), Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification), Myocardial infarction within 1 year before enrollment, Unstable angina within 1 year before enrollment, Poorly controlled hypertension (systolic blood pressure > 150 mm Hg and diastolic blood pressure > 90 mm Hg at screening), Sever chronic lung disease requiring oxygen therapy, Multiple sclerosis or any other demyelinating disease, Epilepsy requiring treatment with antiepileptics (with the exception of epilepsy controlled by antiepileptics, with no occurrence of seizures for at least 3 years before informed consent), and Active malignancy (including ATL); or onset of malignancy or previous treatment for malignancy (with the exception of resected or surgically cured intraepithelial carcinoma of the uterine cervix, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or ductal breast carcinoma) within 5 years before informed consent 2) Active infection 3) Concurrent spinal cord compression lesion (e.g., cervical spine diseases, disk herniation, or ossification of the ligamentum flavum) , with the exception of conditions that would not affect efficacy evaluation in the study, as judged by the investigator or subinvestigator 4) Concurrent dementia 5) Concurrent psychiatric disorder, with the exception of conditions that would not affect obtaining informed consent or efficacy evaluation in the study, as judged by the investigator or subinvestigator 6) History of or current alcohol or drug dependence 7) Planned surgery during the study period 8) Any other conditions unsuitable for participation in the study in the opinion of the investigator or subinvestigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in Osame's motor disability score
- Secondary Outcome Measures
Name Time Method <Efficacy> - HTLV-1 proviral load in peripheral blood and 10 m walking time at each measuring point - Evaluation of muscle spasticity (Modified Ashworth Scale) - Evaluation of Clinical Global Impression(CGI-I,VAS) - Evaluation of Urinary dysfunction(OABSS,I-PSS) - Evaluation of sensory dysfunction(Numbness in the lower limbs (VAS), Pain in the lower limbs (VAS)) - Neopterine Concentration in CSF <Safety> - Adverse events