A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM) (NCT03191526) | Clinical Trial Compass
TerminatedPhase 3
A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)
Stopped: Due to not achieving the primary outcome.
Japan66 participantsStarted 2017-05-22
Plain-language summary
The objective of this study is to assess the efficacy and safety of KW-0761 after intravenous injections in subjects with HTLV-1 associated myelopathy (HAM) in Japan.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Voluntary written informed consent to participate in the study
✓. Diagnosis as HAM according to the second edition of HAM Treatment Manual
✓. At least 1-year history of HAM
✓. Ongoing medication\*1 for HAM, with no changes in 3 months before enrollment; or inadequate response or intolerance to prior medication,\*2 which must have been discontinued for at least 3 months before enrollment. Subjects on maintenance therapy with steroids must have been receiving ≤ 10 mg/day prednisolone equivalent continuously for at least 3 months before enrollment.
✓. No change in the degree of motor dysfunction for at least 3 months before the date of screening, as judged by the investigator or subinvestigator
✓. A OMDS of ≥3 at screening and able to walk ≥10 m at screening (use of a single cane or double canes is allowed)
Exclusion criteria
✕. Any of the following significant concomitant diseases:
✕. Active infection
✕. 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
✕. Concurrent dementia
✕. 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
What they're measuring
1
Improvement in Osame's motor disability score
Timeframe: At week 4, 8 and 12 after second injection