To assess the efficacy and to evaluate safety of HT047 in patients with acute ischemic stroke
This clinical study is designed to initiate treatment with high or low dose HT047 or placebo in subjects with acute ischemic stroke within 2 weeks of onset of the disease and evaluate neurological function recovery in these subjects as measured by the extent of motor function recovery at Week 12 of treatment.
Subjects must have had a recent onset of acute ischemic stroke as confirmed by brain imaging. In terms of symptoms of ischemic stroke, patients who have motor function impairment with FMA motor score ≤ 55 as well as neurological function impairment with K-NIHSS score ≥ 6 and ≤ 15 are eligible for study participation. A subject who is considered by the investigator to be appropriate for study participation and provides informed consent will participate in this study.
At baseline, subjects will be randomized to HT047 high dose group (2250 mg/day), HT047 low dose group (1500 mg/day), or placebo group in a 1:1:1 ratio in a double blind fashion and be treated with the investigational product for 12 weeks starting from the next morning of baseline with a three times a day dosing schedule, 3 tablets per dose.
Since this is a first-in-human trial for HT047, subjects will have a study visit at Week 1 (Day 7) of participation for laboratory tests, ECG, and chest x-ray. A one-month portion of the investigational product will be supplied. During study treatment, subjects will visit the hospital at Weeks 1, 4, 8, and 12.
During the Week 1 visit, the above tests will be performed and the subject's physical status will be checked before he/she is sent home. In the subsequent visits, neurological function assessment and drug exchange will be carried out. At each visit, the study staff should carefully check the subject's medication compliance and verify the accurate number of remaining doses to be countered.
After 12 weeks of study conduct as shown in the above figure, at Week 12, laboratory tests performed at Week 1 will be repeated and overall change in the subject's status will be confirmed before all study procedures are ended.
- Placebo Biological
Intervention Desc: placebo having the same appearance as HT047 Tab. 250mg ARM 1: Kind: Experimental Label: Placebo Description: three times a day dosing schedule 3 tablets per dose
- HT047 High-does group Drug
Intervention Desc: HT047 2250mg, three times a day dosing schedule, 3 tablets per dose ARM 1: Kind: Experimental Label: HT047 High-does group Description: three times a day dosing schedule 3 tablets per dose
- HT047 Low-does group Drug
Intervention Desc: HT047 1500mg, three times a day dosing schedule, 3 tablets per dose ARM 1: Kind: Experimental Label: HT047 Low-does group Description: three times a day dosing schedule 3 tablets per dose
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Change at Week 12 of treatment with HT047 Tab. from baseline in Korean version of Fugl-Meyer Assessment (FMA) motor function score||12 weeks||Yes|
|Secondary||Change at Weeks 4, 8 and 12 from baseline in FMA motor function score||4weeks, 8weeks, 12 weeks||Yes|
|Secondary||Change at Weeks 4, 8, and 12 from baseline in FMA motor function score according to the timing of treatment initiation after the onset of stroke.||4weeks, 8weeks, 12 weeks||Yes|
|Secondary||Change at Weeks 4, 8, and 12 from baseline in FMA motor function score according to the presence of prognostic risk factors (hypertension, diabetes, dyslipidemia, etc.)||4weeks, 8weeks, 12 weeks||Yes|
|Secondary||Change at Weeks 4 and 12 from baseline in Korean-National Institutes of Health Stroke Scale (K-NIHSS) scores||4weeks, 12 weeks||Yes|
|Secondary||Change at Weeks 4 and 12 from baseline in Korean modified Rankin Scale (K-mRS) scores||4weeks, 12weeks||Yes|
|Secondary||Proportion of subjects with K-NIHSS score 0 - 2 at Week 12||12weeks||Yes|
|Secondary||Proportion of subjects with K-mRS score 0, ≤ 1, and ≤ 2 at Week 12||12weeks||Yes|
|Secondary||Change at Weeks 4 and 12 from baseline in Korean Modified Barthel Index (K-MBI) score||4weeks, 12weeks||Yes|
- Hocheol Kim Lead