Brief Summary

The primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with an acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90. The secondary objectives are as follows:

To evaluate the efficacy of PG2 Injection 500 mg versus placebo as determined by Barthel Index (BI) score at Day 90.
To evaluate the efficacy of PG2 Injection 500 mg in reducing the risk of recurrent stroke, cardiovascular events and death of all causes.
To evaluate the safety of PG2 Injection 500 mg treatment

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jun 2012

Typical duration for phase_2

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

First Submitted

Initial submission to the registry

May 20, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2012

Completed

10 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed

Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

May 20, 2012

Last Update Submit

November 3, 2016

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (1)

The primary efficacy variable is the percentage of patients who are categorized as good functional outcome with mRS <2
90 days

Secondary Outcomes (1)

Percentage of patients who achieve a Day 90 BI score of 95-100 Percentage of patients who are free of recurrent stroke, cardiovascular events and death of all causes. Percentage of patients who are free of adverse events
90 days

Study Arms (2)

PG2 Injection 500 mg

EXPERIMENTAL

PG2 Injection 500 mg

Drug: PG2

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

PG2DRUG

STUDY DRUG DOSAGE:IV infusion of PG2 Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg PG2 Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5\~3.5 hrs. The same dose of PG2 Injection 500 mg will be repeated daily for the subsequent 2 days. ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days

Also known as: Polysaccharides of Astragalus membranaceus

PG2 Injection 500 mg

placeboDRUG

STUDY DRUG DOSAGE: IV infusion of Placebo Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg Placebo Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5\~3.5 hrs. The same dose of Placebo Injection 500 mg will be repeated daily for the subsequent 2 days. ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days

Placebo

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients presenting with acute ischaemic stroke
Patient, or a family member with legally authorized responsibility, has given informed consent
Age ≥20 years
Infusion of study medication can be started within 3-6 hrs of stroke onset.
NIHSS score of ≥ 7 - 24

You may not qualify if:

Intracranial haemorrhage (ICH) identified by CT or MRI
Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of \< 6 at randomization
Pre-stroke mRS score of ≥ 2 (indicating previous disability)
Known allergy to Astragalus membranaceus or its mayor derivatives (polysaccharides)
Patients who are eligible for tPA treatment and has been treated with tPA.
Participation in any investigational study in the previous 30 days
Any terminal illness such that patient would not be expected to survive more than 1 year
Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study (this applies to patients with severe microangiopathy such as haemolytic uremic syndrome or thrombotic thrombocytopenic purpura). The judgment is left to the discretion of the Investigator
Pregnant women (clinically evident)
Previous stroke within last three months
Past history or clinical presentation of ICH, arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm.
Current use of oral anticoagulants with prolonged prothrombin time (INR \> 1.6)
Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hrs and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range
Clinically significant hypoglycaemia (blood sugar \< 50mg/dl)
Uncontrolled hypertension defined by a blood pressure \> 185 mmHg systolic or \>110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of "aggressive treatment" is left to the discretion of the responsible Investigator
+1 more criteria

Contact the study team to confirm eligibility.

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan, 404, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

Chung Y. Hsu, PhD
China Medical University Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 20, 2012

First Posted

May 22, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

TW(1)

PG2 Injection 500 mg in Acute Stroke Study (Pass)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

PG2 Injection 500 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

PG2 Injection 500 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations