StrokePhase 2NCT02251197
Safety and Tolerability of BIII 890 in Patients With Acute Ischemic Stroke
A Phase 2 study testing BIII 890 CL in people with Stroke, run by Boehringer Ingelheim.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- BIII 890 CL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Oct 2002
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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)
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- BIII 890 CL, Placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIII 890 CLDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIII 890 CL | Experimental | escalating doses Receives: Drug: BIII 890 CL |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: up to 45 days
Number of patients with clinically relevant findings in vital signs
Measured: up to 30 days
Number of patients with clinically relevant findings in electrocardiogram (ECG)
Measured: up to 45 days
Number of patients with clinically relevant findings in laboratory evaluation
Measured: up to 45 days
Secondary outcomes (12)
Maximum concentration in plasma
Measured: up to 120 hours after drug administration
Time to reach maximum concentration in plasma
Measured: up to 120 hours after drug administration
Terminal elimination half-life
Measured: up to 120 hours after drug administration
Terminal rate constant
Measured: up to 120 hours after drug administration
Area under the plasma concentration-time curve
Measured: up to 120 hours after drug administration
Mean residence time
Measured: up to 120 hours after drug administration
Plasma clearance
Measured: up to 120 hours after drug administration
Volume of distribution at steady state
Measured: up to 120 hours after drug administration
Glutamate plasma concentrations
Measured: up to 72 hours after start of infusion
Change in modified Rankin Scale
Measured: Baseline, day 30
Barthel Index
Measured: Day 30
Change in NIH stroke scale
Measured: Baseline, day 1, 3, 7 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startJul 2001
- Primary completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251197
- Sponsor's protocol ID
- 599.3
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2014
- Last updated
- 29 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02251197
- Acronym / sponsor ID
- 599.3
- Conditions
- Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- Oct 2002 (actual)
- First posted
- 29 Sep 2014 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIII 890 CL | Experimental | Drug: BIII 890 CLescalating doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
- 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)
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 |
|---|---|---|
| BIII 890 CL | Drug | BIII 890 CL |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with adverse events
Time frame: up to 45 days
Number of patients with clinically relevant findings in vital signs
Time frame: up to 30 days
Number of patients with clinically relevant findings in electrocardiogram (ECG)
Time frame: up to 45 days
Number of patients with clinically relevant findings in laboratory evaluation
Time frame: up to 45 days
12 secondary outcomes
Maximum concentration in plasma
Time frame: up to 120 hours after drug administration
Time to reach maximum concentration in plasma
Time frame: up to 120 hours after drug administration
Terminal elimination half-life
Time frame: up to 120 hours after drug administration
Terminal rate constant
Time frame: up to 120 hours after drug administration
Area under the plasma concentration-time curve
Time frame: up to 120 hours after drug administration
Mean residence time
Time frame: up to 120 hours after drug administration
Plasma clearance
Time frame: up to 120 hours after drug administration
Volume of distribution at steady state
Time frame: up to 120 hours after drug administration
Glutamate plasma concentrations
Time frame: up to 72 hours after start of infusion
Change in modified Rankin Scale
Time frame: Baseline, day 30
Barthel Index
Time frame: Day 30
Change in NIH stroke scale
Time frame: Baseline, day 1, 3, 7 and 30
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 29 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIII 890 CL in people with Stroke, run by Boehringer Ingelheim.
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 20 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 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients with adverse events (time frame: up to 45 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2014.