Clinical Trial to Assess the Efficacy and to Evaluate Safety of HT047 in Patients With Acute Ischemic Stroke

NCT02828540 | Completed Phase 2 DMC

• 1 other identifier: HT047-201
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 8

Brief Summary

To assess the efficacy and to evaluate safety of HT047 in patients with acute ischemic stroke

Conditions

Ischemic Stroke

Keywords

HT047; Pueraria lobata; Scutellaria baicalensis

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (8)

• Change at Weeks 4, 8 and 12 from baseline in FMA motor function score

  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.

  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.)

  4weeks, 8weeks, 12 weeks

• Change at Weeks 4 and 12 from baseline in Korean-National Institutes of Health Stroke Scale (K-NIHSS) scores

  4weeks, 12 weeks

• Change at Weeks 4 and 12 from baseline in Korean modified Rankin Scale (K-mRS) scores

  4weeks, 12weeks

Study Arms (3)

HT047 High-dose group

EXPERIMENTAL

three times a day dosing schedule 3 tablets per dose

Drug: HT047 High-dose group

HT047 Low-dose group

EXPERIMENTAL

three times a day dosing schedule 3 tablets per dose

Drug: HT047 Low-dose group

Placebo

PLACEBO COMPARATOR

three times a day dosing schedule 3 tablets per dose

Drug: Placebo

Interventions

HT047 High-dose group DRUG

HT047 2250mg, three times a day dosing schedule, 3 tablets per dose

HT047 High-dose group

HT047 Low-dose group DRUG

HT047 1500mg, three times a day dosing schedule, 3 tablets per dose

HT047 Low-dose group

Placebo DRUG

placebo having the same appearance as HT047 Tab. 250mg

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hocheol Kim: lead

Study Sites (8)

Myongji Hospital

Goyang-si, Gyeonggi-do, 10475, South Korea

Location

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 11923, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 18450, South Korea

Location

Chosun University Hospital

Gwangju, 61453, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Hanyang University Medical Center

Seoul, 04763, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31651889 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Dae-Il Chang

  Kyung Hee University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 11, 2016
• Study Start: August 4, 2016
• Primary Completion: August 3, 2018
• Study Completion: August 3, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

KR (8)