Ischemic StrokePhase 2NCT02828540
Clinical Trial to Assess the Efficacy and to Evaluate Safety of HT047 in Patients With Acute Ischemic Stroke
A Phase 2 study testing HT047 High-dose group and HT047 Low-dose group in people with Ischemic Stroke, run by Hocheol Kim at 8 sites in South Korea.
Trial summary
To assess the efficacy and to evaluate safety of HT047 in patients with acute ischemic stroke Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- HT047 High-dose group and HT047 Low-dose group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 4 Aug 2016to 3 Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult at the age of ≥ 19
- Diagnosis of acute ischemic stroke by brain imaging within 14 days of screening
- FMA motor score ≤ 55 with arm or leg weakness at screening
- K-NIHSS score ≥ 4 and ≤ 15 at screening
- Individuals who have visual and hearing abilities to perform the trial; who are able to understand the words and sentences necessary to evaluate the efficacy and safety, as well as the investigator's instructions; and who are able to communicate (such as gestures, writing, speaking, etc.)
- Voluntary written informed consent to study participation
Who cannot join
- Presence of motor function impairment, which is caused by previous stroke except acute ischemic stroke occurring within 14 days of screening (A subject with previous history of stroke may participate if he/she showed no motor function impairment and the K-mRS score was ≤1 (0-1))
- Diagnosis of and current treatment for degenerative neurological diseases, e.g., Parkinson's disease and Alzheimer's disease
- Current treatment with amphetamines, selective serotonin reuptake inhibitors, or antipsychotics
- Presence of brain diseases, such as brain tumor, traumatic brain damage, arteriovenous malformation, or moyamoya disease, or ischemic stroke caused by these diseases
- Impaired ability to walk upright due to other illness prior to screening
- Unstable vital signs at screening based on the judgment of the investigator e.g., systolic blood pressure ≥ 170mmHg despite antihypertensive treatment or other symptoms such as hyperthermia, tachycardia, or hyperventilation
Show all 23Show fewer
- Diagnosis of liver diseases prior to screening, such as hepatitis and liver cirrhosis, or current treatment for these diseases
- Continuous treatment with potentially hepatotoxic drugs e.g., current treatment with propylthiouracil, ketoconazole, isoniazid, valproic acid, phenytoin, etc. that may induce acute hepatotoxicity
- Severe, New York Heart Association (NYHA) Class III or higher heart failure at screening [NYHA Classes of heart failure] Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities.
- Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion.
- Class III: patients with marked limitation of activity; they are comfortable only at rest.
- Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on.
- Diagnosis of or treatment for cancer within 6 months of screening or presence of recurrent or metastatic cancer
- Treatment with or intake of traditional oriental medicine (herbal medicine) or health functional foods containing potentially hepatotoxic plants, such as Germander (Teucrium chamaedrys, Teucrium polium), toothed clubmoss (Lycopodium serratum), or celandine (Chelidonium majus), within 4 weeks prior to study participation
- Treatment with or intake of traditional Korean medicine containing pueraria root and/or scutellaria root or other drugs or health functional foods containing their respective index components, i.e. puerarin and baicalin, within 4 weeks prior to study participation
- Hematologic findings as follows
- ① Increased serum aspartate or alanine aminotransferase (AST/ALT) levels ≥ 1.5 x site specific upper limit of normal in laboratory test
- ② Decreased hemoglobin (Hb) level (Hb< 10 g/dl), decreased platelet (PLT) level (PLT< 100,000/mm3), or hematocrit (Hct) level < 25% in whole blood count test.
- ③ Increased serum creatinine (Cr) level (Cr > 2.0 mg/dl) in laboratory test or patient on dialysis
- Pregnant or lactating women A woman of childbearing potential can participate in the study only if non-pregnancy is confirmed.
- Subjects must use a double barrier method or must have been surgically sterilized.
- Previous participation in a clinical study for another drug within 3 months of screening. A subject who participated in an observational study that did not involve drug treatment may participate in this study.
- Individuals who are considered by the investigator to be inadequate for study participation due to other reasons.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Myongji Hospital
Goyang-si, Gyeonggi-do, 10475
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923
Chosun University Hospital
Gwangju, 61453
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450
Gachon University Gil Medical Center
Incheon, 21565
Kyung Hee University Hospital
Seoul, 02447
Hanyang University Medical Center
Seoul, 04763
Kyung Hee University Hospital at Gangdong
Seoul, 05278
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Assess the Efficacy and to Evaluate Safety of HT047 in Patients With Acute Ischemic Stroke
To assess the efficacy and to evaluate safety of HT047 in patients with acute ischemic stroke
Read the detailed description
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 ≥ 4 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.
- Conditions
- Ischemic Stroke
- Being tested
- HT047 High-dose group, HT047 Low-dose group, Placebo
- Keywords
- HT047, Pueraria lobata, Scutellaria baicalensis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HT047 High-dose groupDrug
HT047 2250mg, three times a day dosing schedule, 3 tablets per dose
HT047 Low-dose groupDrug
HT047 1500mg, three times a day dosing schedule, 3 tablets per dose
PlaceboDrug
placebo having the same appearance as HT047 Tab. 250mg
| Study group | Role | What they receive |
|---|---|---|
| HT047 High-dose group | Experimental | three times a day dosing schedule 3 tablets per dose Receives: Drug: HT047 High-dose group |
| HT047 Low-dose group | Experimental | three times a day dosing schedule 3 tablets per dose Receives: Drug: HT047 Low-dose group |
| Placebo | Placebo comparator | three times a day dosing schedule 3 tablets per dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change at Week 12 of treatment with HT047 Tab. from baseline in Korean version of Fugl-Meyer Assessment (FMA) motor function score
Total score of motor function test for upper extremity in 66 marks plus total score of motor function test for lower extremity in 34 marks is 100 marks.
Measured: 12 weeks
Secondary outcomes (8)
Change at Weeks 4, 8 and 12 from baseline in FMA motor function score
Total score of motor function test for upper extremity in 66 marks plus total score of motor function test for lower extremity in 34 marks is 100 marks.
Measured: 4weeks, 8weeks, 12 weeks
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.
Total score of motor function test for upper extremity in 66 marks plus total score of motor function test for lower extremity in 34 marks is 100 marks.
Measured: 4weeks, 8weeks, 12 weeks
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.)
Total score of motor function test for upper extremity in 66 marks plus total score of motor function test for lower extremity in 34 marks is 100 marks.
Measured: 4weeks, 8weeks, 12 weeks
Change at Weeks 4 and 12 from baseline in Korean-National Institutes of Health Stroke Scale (K-NIHSS) scores
Total score of K-NIHSS would be scored by 11 categories.
Measured: 4weeks, 12 weeks
Change at Weeks 4 and 12 from baseline in Korean modified Rankin Scale (K-mRS) scores
Different 6 questions can be scored by 0-5 marks.
Measured: 4weeks, 12weeks
Proportion of subjects with K-NIHSS score 0 - 2 at Week 12
Total score of K-NIHSS would be scored by 11 categories.
Measured: 12weeks
Proportion of subjects with K-mRS score 0, ≤ 1, and ≤ 2 at Week 12
Different 6 questions can be scored by 0-5 marks.
Measured: 12weeks
Change at Weeks 4 and 12 from baseline in Korean Modified Barthel Index (K-MBI) score
Total scores (0-100) should be rated by 5 stages in 10 categories.
Measured: 4weeks, 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start4 Aug 2016
- Primary completion3 Aug 2018
- Study completion3 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hocheol Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hocheol Kim, Kyunghee University
- Investigators
- Dae-Il Chang, Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828540
- Sponsor's protocol ID
- HT047-201
- Status last verified
- Sep 2018
- First submitted
- 24 Jun 2016
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Heo SH, Song J, Kim BJ, Kim H, Chang DI; HT047 investigators. Rationale and design to assess the efficacy and safety of HT047 in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase II trial. Medicine (Baltimore). 2019 Oct;98(43):e17655. doi: 10.1097/MD.0000000000017655.
PubMed 31651889
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Assess the Efficacy and to Evaluate Safety of HT047 in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02828540
- Acronym / sponsor ID
- HT047-201
- Conditions
- Ischemic Stroke
- Keywords
- HT047, Pueraria lobata, Scutellaria baicalensis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hocheol KimUniversity, hospital or other
- Study start
- 4 Aug 2016
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 3 Aug 2018 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and to evaluate safety of HT047 in patients with acute ischemic stroke
Detailed description
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 ≥ 4 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HT047 High-dose group | Experimental | Drug: HT047 High-dose groupthree times a day dosing schedule 3 tablets per dose |
| HT047 Low-dose group | Experimental | Drug: HT047 Low-dose groupthree times a day dosing schedule 3 tablets per dose |
| Placebo | Placebo comparator | Drug: Placebothree times a day dosing schedule 3 tablets per dose |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult at the age of ≥ 19
- Diagnosis of acute ischemic stroke by brain imaging within 14 days of screening
- FMA motor score ≤ 55 with arm or leg weakness at screening
- K-NIHSS score ≥ 4 and ≤ 15 at screening
- Individuals who have visual and hearing abilities to perform the trial; who are able to understand the words and sentences necessary to evaluate the efficacy and safety, as well as the investigator's instructions; and who are able to communicate (such as gestures, writing, speaking, etc.)
Key exclusion criteria (23 listed)
- Presence of motor function impairment, which is caused by previous stroke except acute ischemic stroke occurring within 14 days of screening (A subject with previous history of stroke may participate if he/she showed no motor function impairment and the K-mRS score was ≤1 (0-1))
- Diagnosis of and current treatment for degenerative neurological diseases, e.g., Parkinson's disease and Alzheimer's disease
- Current treatment with amphetamines, selective serotonin reuptake inhibitors, or antipsychotics
- Presence of brain diseases, such as brain tumor, traumatic brain damage, arteriovenous malformation, or moyamoya disease, or ischemic stroke caused by these diseases
- Impaired ability to walk upright due to other illness prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HT047 High-dose groupHT047 2250mg, three times a day dosing schedule, 3 tablets per dose | Drug | HT047 High-dose group |
| HT047 Low-dose groupHT047 1500mg, three times a day dosing schedule, 3 tablets per dose | Drug | HT047 Low-dose group |
| Placeboplacebo having the same appearance as HT047 Tab. 250mg | Drug | Placebo |
Primary outcome
Change at Week 12 of treatment with HT047 Tab. from baseline in Korean version of Fugl-Meyer Assessment (FMA) motor function score
Time frame: 12 weeks
Total score of motor function test for upper extremity in 66 marks plus total score of motor function test for lower extremity in 34 marks is 100 marks.
8 secondary outcomes
Change at Weeks 4, 8 and 12 from baseline in FMA motor function score
Time frame: 4weeks, 8weeks, 12 weeks
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.
Time frame: 4weeks, 8weeks, 12 weeks
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.)
Time frame: 4weeks, 8weeks, 12 weeks
Change at Weeks 4 and 12 from baseline in Korean-National Institutes of Health Stroke Scale (K-NIHSS) scores
Time frame: 4weeks, 12 weeks
Change at Weeks 4 and 12 from baseline in Korean modified Rankin Scale (K-mRS) scores
Time frame: 4weeks, 12weeks
Proportion of subjects with K-NIHSS score 0 - 2 at Week 12
Time frame: 12weeks
Proportion of subjects with K-mRS score 0, ≤ 1, and ≤ 2 at Week 12
Time frame: 12weeks
Change at Weeks 4 and 12 from baseline in Korean Modified Barthel Index (K-MBI) score
Time frame: 4weeks, 12weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Derived from this study: PubMed 31651889Heo SH, Song J, Kim BJ, Kim H, Chang DI; HT047 investigators. Rationale and design to assess the efficacy and safety of HT047 in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase II trial. Medicine (Baltimore). 2019 Oct;98(43):e17655. doi: 10.1097/MD.0000000000017655.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dae-Il Chang principal investigator
Kyung Hee University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HT047 High-dose group and HT047 Low-dose group in people with Ischemic Stroke, run by Hocheol Kim at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change at Week 12 of treatment with HT047 Tab. from baseline in Korean version of Fugl-Meyer Assessment (FMA) motor function score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.