StrokePhase 2NCT00044915
Repinotan in Patients With Acute Ischemic Stroke
A Phase 2 study testing Repinotan HCl (BAYX3702) in people with Stroke and Acute Ischemic Stroke, run by Bayer at 119 sites in 15 countries.
Trial summary
The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic Stroke
- What is being tested?
- Repinotan HCl (BAYX3702)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 782 participants
- Where
- 119 sitesin 15 countries
- Study dates
- Dec 2000to Sep 2004
- 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
- Acute ischemic stroke of hemispheric localization (exclude brainstem and cerebellum), of suspected thromboembolic origin.
- Males or females aged 18 years or over.
- National Institute of Health Stroke Scale (NIH-SS) total score 8 to 23 with a motor deficit >/= 2 (for either one arm or leg) and level of consciousness < 2 and at least one of the following: Visual field deficit, neglect, or aphasia. If a patient receives t-PA, NIH-SS must be performed prior to receiving the study drug but after infusion of t-PA is initiated.
- Signed informed consent from patient or legally authorized representative
Who cannot join
- CT scan evidence of:
- Clearly defined areas of hypodensity indicating infarction of >1/3 of the MCA territory or evidence of significant mass effect with shift of midline or major areas of sulcal effacement associated with loss of cortical definition (grey-white distinction). Minor early CT changes are common in MCA strokes and patients with early or subtle changes are eligible.
- A primary intra-cerebral haemorrhage or any finding not consistent with an acute ischemic stroke as the cause of presenting symptoms.
- Clinical evidence of acute stroke due to lacunar infarct (pure motor hemiplegia; pure sensory deficit, ataxia/clumsy hand syndromes)
- Neurological (other than the presenting stroke) or psychiatric conditions that may affect the patient's functional status and/or that may interfere with the patient's assessment
- Clinically relevant pre-existing neurological deficit (Historical Rankin score >/= 2 regardless of cause)
Show all 19Show fewer
- Generalized seizures having developed since the onset of stroke symptoms
- Systolic blood pressure > 210 or < 110 mmHg (confirmed by up to three readings prior to randomization)
- Diastolic blood pressure > 110 or < 60 mmHg (confirmed by up to three readings prior to randomization)
- Myocardial infarction within 3 months, unstable angina within 3-5 days prior to starting infusion, unstable supra-ventricular and/or ventricular arrhythmia, severe conduction defect (AV block grades 2 and 3), complete left or right Bundle Branch Block, bradycardia (heart rate [HR] less than 50 bpm), uncompensated heart failure
- History of myocarditis, cardiomyopathy or aortic stenosis
- Patients known to have prolonged QTc intervals (inherited and sporadic syndromes of QTc prolongation or QTc interval > 450 msec males and 470 msec females on baseline ECG) or using Class IA or Class III antiarrhythmic drugs (e.g., quinidine, procainamide, amiodarone, sotalol)
- Any patients that require initiation of new digoxin therapy are excluded. Patients already on digoxin therapy (for at least 1 month stable dose) at time of enrollment will be allowed in the study.
- Electrolyte imbalance at baseline. Should the results not be available before starting the study drug infusion, the patients will be allowed in the study providing that the corrective therapy of any abnormal electrolyte results is implemented immediately upon availability of the laboratory report.
- Any conditions predisposing to electrolyte imbalances (e.g., chronic vomiting, anorexia nervosa, bulimia nervosa) will also be excluded at baseline.
- Participation in a research protocol for investigation of a pharmaceutical agent or innovative invasive procedure (including intra-arterial t-PA) within the past 30 days
- Previously in the BRAIN-Study or treated with repinotan
- Life expectancy of less than 6 months due to comorbid conditions
- Any other known clinically significant medical disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal, endocrine, major uncompensated metabolic disturbances, respiratory, immunological, hematological or bleeding disorder, cancer, AIDS)
Trial locations and contacts
119 sites in 15 countries.
119 sites in 15 countries
United States28 sites
Study site
Baltimore, Maryland, 21224
Study site
Beaufort, South Carolina, 29902-5472
Study site
Bellevue, Washington, 98004-4687
Study site
Boynton Beach, Florida, 33435-6000
Study site
Chapel Hill, North Carolina, 27599-7065
Study site
Chattanooga, Tennessee, 37403-2112
Study site
Cleveland, Ohio, 44109-1998
Study site
Decatur, Georgia, 30033
Study site
Des Moines, Iowa, 50314
Study site
Edison, New Jersey, 08818-3903
Study site
Fort Lauderdale, Florida, 33308
Study site
Great Falls, Montana, 59405
Study site
Honolulu, Hawaii, 96813-2413
Study site
Houston, Texas, 77030
Study site
Los Angeles, California, 90024-1777
Study site
New Hyde Park, New York, 11040-1496
Study site
Ocala, Florida, 34471
Study site
Oceanside, California, 92056-4405
Study site
Philadelphia, Pennsylvania, 19107
Study site
Portland, Oregon, 97225
Study site
Ridgewood, New Jersey, 07450
Study site
Robbinsdale, Minnesota, 55422-2900
Study site
San Diego, California, 92103-8765
Study site
San Jose, California, 95124
Study site
Stony Brook, New York, 11794
Study site
Tampa, Florida, 33606
Study site
Upland, Pennsylvania, 19013-3995
Study site
Winston-Salem, North Carolina, 27103
Germany22 sites
Study site
Aschaffenburg, Bavaria, 63739
Study site
Bad Neustadt an der Saale, Bavaria, 97616
Study site
Berlin, State of Berlin, 10117
Study site
Berlin, State of Berlin, 10249
Study site
Cologne, North Rhine-Westphalia, 50931
Study site
Erlangen, Bavaria, 91054
Study site
Essen, North Rhine-Westphalia, 45147
Study site
Frankfurt am Main, Hesse, 60596
Study site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Study site
Greifswald, Mecklenburg-Vorpommern, 17489
Study site
Heidelberg, Baden-Wurttemberg, 69120
Study site
Kaiserslautern, Rhineland-Palatinate, 67655
Study site
Leipzig, Saxony, 04103
Study site
Magdeburg, Saxony-Anhalt, 39112
Study site
Minden, North Rhine-Westphalia, 32427
Study site
München, Bavaria, 81377
Study site
München, Bavaria, 81545
Study site
Münster, North Rhine-Westphalia, 48149
Study site
Nuremberg, Bavaria, 90419
Study site
Regensburg, Bavaria, 93053
Study site
Tübingen, Baden-Wurttemberg, 72076
Study site
Würzburg, Bavaria, 97080
Canada18 sites
Study site
Calgary, Alberta, T2N 2T9
Study site
Chicoutimi, Quebec, G7H 5H6
Study site
Edmonton, Alberta, T6G 2B7
Study site
Greenfield Park, Quebec, J4V 2H1
Study site
Halifax, Nova Scotia, B3H 3A7
Study site
Lethbridge, Alberta, T1KOC9
Study site
London, Ontario, N6A 5A5
Study site
Mississauga, Ontario, L5B 1B8
Study site
North Vancouver, British Columbia, V7L 2L3
Study site
Ottawa, Ontario, K1H 8L6
Study site
Penticton, British Columbia, V2A 3G6
Study site
Québec, Quebec, G1J 1Z4
Study site
Saint John, New Brunswick, E2L 4L2
Study site
Saskatoon, Saskatchewan, S7N 0W8
Study site
Toronto, Ontario, M5T 2S8
Study site
Vancouver, British Columbia, V5Z 1M9
Study site
Victoria, British Columbia, V8Z 6R5
Study site
Winnipeg, Manitoba, R2H 2A6
Italy10 sites
Study site
Como, 22100
Study site
L’Aquila, 67100
Study site
Milan, 20153
Study site
Pavia, 27100
Study site
Perugia, 06126
Study site
Reggio Emilia, 42100
Study site
Roma, 00155
Study site
Verona, 37126
Study site
Vibo Valentia, 89900
Study site
Vicenza, 36100
Australia8 sites
Study site
Gosford, New South Wales, 2250
Study site
Hobart, Tasmania, 7000
Study site
Melbourne, Victoria, 3011
Study site
Melbourne, Victoria, 3052
Study site
Melbourne, Victoria, 3084
Study site
Melbourne, Victoria, 3181
Study site
New Lambton Heights, New South Wales, 2305
Study site
Southport, Queensland, 4215
Israel8 sites
Study site
Ashkelon, 78306
Study site
Haifa, 31048
Study site
Haifa, 31096
Study site
Holon, 58100
Study site
Nahariya, 22100
Study site
Petah Tikva, Isarel, 49372
Study site
Tel Aviv, 64239
Study site
Tel HaShomer, 52621
Spain6 sites
Study site
Barcelona, Barcelona, 08003
Study site
Barcelona, Barcelona, 08035
Study site
Madrid, Madrid, 28046
Study site
Santiago de Compostela, A Coruña, 15706
Study site
Valencia, Valencia, 46010
Study site
Zaragoza, Zaragoza, 50009
Finland4 sites
Study site
Helsinki, 00290
Study site
Kuopio, 70120
Study site
Lahti, 15850
Study site
Mikkeli, FIN-50100
Austria3 sites
Study site
Klosterneuburg, Lower Austria, 3400
Study site
Linz, Upper Austria, 4020
Study site
Vienna, State of Vienna, 1021
United Kingdom3 sites
Study site
Dundee, Tayside, DD2 1UB
Study site
Glasgow, Strathclyde, G51 4TG
Study site
Leicester, Leicestershire, LE1 5WW
Netherlands2 sites
Study site
Groningen, 9713 GZ
Study site
Nijmegen, 6525 GA
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic / Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke
The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours.
- Conditions
- Stroke, Acute Ischemic Stroke
- Being tested
- Repinotan HCl (BAYX3702), Placebo
- Keywords
- Acute Ischemic Stroke Without Hemorrhage
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repinotan HCl (BAYX3702)Drug
All patients receive 1.25 mg of repinotan
PlaceboDrug
All patients receive 1.25 mg of placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: Repinotan HCl (BAYX3702) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2002 (estimated)
- Study startDec 2000
- Study completionSep 2004
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 BayerThe 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
- Who is masked
- Participant, Investigator
- Enrolment
- 782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044915
- Sponsor's protocol ID
- 100282
- Status last verified
- Jun 2009
- First submitted
- 6 Sep 2002
- Last updated
- 12 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic / Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00044915
- Acronym / sponsor ID
- 100282
- Conditions
- Stroke, Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke Without Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 782 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Study completion
- Sep 2004 (actual)
- First posted
- 9 Sep 2002 (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 purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Repinotan HCl (BAYX3702) |
| Arm 2 | 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 (4 listed)
- Acute ischemic stroke of hemispheric localization (exclude brainstem and cerebellum), of suspected thromboembolic origin.
- Males or females aged 18 years or over.
- National Institute of Health Stroke Scale (NIH-SS) total score 8 to 23 with a motor deficit >/= 2 (for either one arm or leg) and level of consciousness < 2 and at least one of the following: Visual field deficit, neglect, or aphasia. If a patient receives t-PA, NIH-SS must be performed prior to receiving the study drug but after infusion of t-PA is initiated.
- Signed informed consent from patient or legally authorized representative
Key exclusion criteria (19 listed)
- CT scan evidence of:
- Clearly defined areas of hypodensity indicating infarction of >1/3 of the MCA territory or evidence of significant mass effect with shift of midline or major areas of sulcal effacement associated with loss of cortical definition (grey-white distinction). Minor early CT changes are common in MCA strokes and patients with early or subtle changes are eligible.
- A primary intra-cerebral haemorrhage or any finding not consistent with an acute ischemic stroke as the cause of presenting symptoms.
- Clinical evidence of acute stroke due to lacunar infarct (pure motor hemiplegia; pure sensory deficit, ataxia/clumsy hand syndromes)
- Neurological (other than the presenting stroke) or psychiatric conditions that may affect the patient's functional status and/or that may interfere with the patient's assessment
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 |
|---|---|---|
| Repinotan HCl (BAYX3702)All patients receive 1.25 mg of repinotan | Drug | Arm 1 |
| PlaceboAll patients receive 1.25 mg of placebo | Drug | Arm 2 |
Primary outcome
Not reported in the source record.
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 12 Jun 2009.
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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.
Bayer Study Director study director
Bayer
119 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Repinotan HCl (BAYX3702) in people with Stroke and Acute Ischemic Stroke, run by Bayer at 119 sites in 15 countries.
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 4 inclusion and 19 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 12 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 119 sites in United States, Germany, Canada, Italy, Australia and 10 more countries. 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.
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 12 Jun 2009.