- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02251197
Safety and Tolerability of BIII 890 in Patients With Acute Ischemic Stroke
September 25, 2014 updated by: Boehringer Ingelheim
A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Evaluate the Safety and Tolerability in 108 Patients (18 Per Dose Group) With Acute Ischemic Stroke After Intravenous Administration From 6 to 72 Hours of BIII 890, as Loading Dose Followed by Maintenance Dose, in Escalating Dose Panels From 87.5 mg up to 1495 mg (Total Dose)
The objective of this study is to assess the safety, tolerability and pharmacokinetic characteristics of BIII 890 after intravenous infusion in acute ischemic stroke patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients aged 18 years or above
- Patients with an acute onset of a focal neurological deficit secondary to a lesion presumed to be ischemic in etiology involving the carotid and/or vertebrobasilar artery territories
- Onset of symptoms within 24 hours prior to initiation of administration of study drug. If the patient has awakened from sleep with the deficit, the time of onset will be considered as the last time he/she was normal
- Stroke symptoms are to be present for at least 1 hour and are still present at randomisation. Symptoms must be distinguishable from an episode of generalised ischemia (i.e. syncope), seizure, migraine or hypoglycaemic disorder
- Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each Patient (or the subject's representative or relatives, depending on local regulations) according to Good Clinical Practice and regulatory and legal requirements of the participating country. Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtfully that they are wiling to participate voluntarily and must be able to understand an Explanation of the contents of the Information sheet
- Patient's life expectancy is at least 30 days (investigator's judgement)
Exclusion Criteria:
- Presence of only minor stroke symptoms as characterised by a NIH score of < 4 at the time of randomisation
- Severe obtundation as defined by a NIH Stroke Scale score of ≥ 2 using the Level of Consciousness category; including coma or severe stupor
Any patient with a concurrent, severe neurological disease
- Dementia, multi-infarct dementia
- Multiple sclerosis
- Previous stroke with residual deficit (i.e. pre-stroke modified Rankin Scale (mRS) must be ≤ 1). Tomographic or clinical evidence of brain stem infarct, any intracranial haemorrhage, primary or metastatic brain tumour, meningioma, or other space occupying lesion (e.g., subdural or epidural haematoma)
- Patient with history of seizure related or not to their stroke diagnosis, except seizure secondary to fever in the childhood
- Any patients with a concurrent mental deficit (e.g., AXIS-I psychiatric disorders as defined by the Diagnostic and Statistical Manual (DSM) IV criteria: schizophrenia, mood disorders (mania or major depression), psychotic/delusional disorders, a recent history (6 months) or current evidence of alcohol or recreational drug abuse
- Baseline blood glucose values below 2.75 mmol/l (hypoglycaemia) or above 22.0 mmol/l (hyperglycaemia)
- Sustained supine hypertension during the baseline period, and prior to randomisation, as defined as two readings 30 minutes apart with a systolic blood pressure ≥ 220 mmHg and/or a diastolic blood pressure ≥ 120 mmHg; and/or clinical diagnosis of malignant hypertensive crisis accompanied by other signs or symptoms (e.g. nausea, vomiting, obtundation, etc.) or complications (e.g. papilledema, retinal haemorrhage, hematuria, or congestive heart failure)
- Patients with known history of orthostatic hypotension, fainting spells or blackouts. Hypotension as defined by a systolic blood pressure ≤ 90 mmHg or a diastolic blood pressure ≤ 50 mmHg
- Patients currently on oral anticoagulants. A time window of at least two days should be observed when such a treatment has been administered and stopped before the beginning of the trial
Known history of a serious, advanced, unstable or terminal illness that in the opinion of the clinical investigator may interfere with the trial by confounding the results or pose an additional risk:
- cardiogenic shock, congestive heart failure (NYHA Class III-IV), acute myocardial infarction or history of a myocardial infarction within the past three months, unstable angina
- renal failure, severe hepatic disease, unstable gastrointestinal, pulmonary, metabolic, immunological, hormonal disorders
- cancer (except local skin cancers, e.g.: basal or squamous carcinoma)
- HIV+
- Females who are lactating or pregnant (as determined by a pregnancy test during screening) or of childbearing potential
- Current or recent (within 3 months) participation in another investigational drug protocol
- Patient cannot be followed for 30 days (according to the judgement of the investigator)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: BIII 890 CL
escalating doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events
Time Frame: up to 45 days
|
up to 45 days
|
Number of patients with clinically relevant findings in vital signs
Time Frame: up to 30 days
|
up to 30 days
|
Number of patients with clinically relevant findings in electrocardiogram (ECG)
Time Frame: up to 45 days
|
up to 45 days
|
Number of patients with clinically relevant findings in laboratory evaluation
Time Frame: up to 45 days
|
up to 45 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum concentration in plasma
Time Frame: up to 120 hours after drug administration
|
up to 120 hours after drug administration
|
Time to reach maximum concentration in plasma
Time Frame: up to 120 hours after drug administration
|
up to 120 hours after drug administration
|
Terminal elimination half-life
Time Frame: up to 120 hours after drug administration
|
up to 120 hours after drug administration
|
Terminal rate constant
Time Frame: up to 120 hours after drug administration
|
up to 120 hours after drug administration
|
Area under the plasma concentration-time curve
Time Frame: up to 120 hours after drug administration
|
up to 120 hours after drug administration
|
Mean residence time
Time Frame: up to 120 hours after drug administration
|
up to 120 hours after drug administration
|
Plasma clearance
Time Frame: up to 120 hours after drug administration
|
up to 120 hours after drug administration
|
Volume of distribution at steady state
Time Frame: up to 120 hours after drug administration
|
up to 120 hours after drug administration
|
Glutamate plasma concentrations
Time Frame: up to 72 hours after start of infusion
|
up to 72 hours after start of infusion
|
Change in modified Rankin Scale
Time Frame: Baseline, day 30
|
Baseline, day 30
|
Barthel Index
Time Frame: Day 30
|
Day 30
|
Change in NIH stroke scale
Time Frame: Baseline, day 1, 3, 7 and 30
|
Baseline, day 1, 3, 7 and 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2001
Primary Completion (Actual)
October 1, 2002
Study Registration Dates
First Submitted
September 25, 2014
First Submitted That Met QC Criteria
September 25, 2014
First Posted (Estimate)
September 29, 2014
Study Record Updates
Last Update Posted (Estimate)
September 29, 2014
Last Update Submitted That Met QC Criteria
September 25, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 599.3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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