Ischemic StrokePhase 1IVIG/AISNCT01628055
IVIG in Acute Ischemic Stroke: A Pilot Study
A Phase 1 study testing Privigen and Normal Saline in people with Ischemic Stroke, run by Inova Health Care Services at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the ability of IVIG to affect the rate of progression of brain ischemia, as evidenced by neuroimaging. The results of an ongoing epidemiological study indicate that patients with primary immunodeficiency (PID) on IVIG replacement therapy have an overall prevalence of stroke that… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Privigen and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Sep 2013
- Phase
- Phase 1
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Onset of neurological symptoms between 4.5 and 8 hours
- Male or Female age 45 -75 years old
- Score of 10-15 points on the National Institutes of Health Stroke Scale (NIHSS) with clinical signs suggestive of ischemic stroke
- Acute brain ischemia with a distinct penumbra (at least 20%), measured by magnetic resonance perfusion imaging (PI) and diffusion-weighted imaging (DWI), in the territory of the middle cerebral artery, anterior cerebral artery, or posterior cerebral artery with a hemispheric distribution
- Ability and willingness to provide informed consent and comply with study requirements and procedures
Who cannot join
- Eligibility for acute thrombolytic (rtPA) treatment
- Normal brain MRI
- Transient ischemic attack or rapidly improving neurological symptoms
- Previous disability
- Hemorrhagic stroke on brain MRI (T2*/SWI)
- Ongoing infection defined by clinical and laboratory signs: an evidence-based guideline will be followed to detect infectious complications (in short, physical and laboratory measures including WBC, ESR, hsCRP, PCT, fever, abnormal urine, chest X-ray or positive cultures)
Show all 15Show fewer
- Diagnosis of malignancy
- Known sensitivity to any ingredients in the study drug or radiological contrast material
- Participation in another clinical trial within the past 30 days
- Stroke in the previous 3 months
- Chronic liver, kidney or hematological disease
- Contraindications to MRI -Brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body e.g. metal shavings, other implanted medical devices: (e.g. Swan Ganz catheter) insulin pump, metal shrapnel or bullet.
- Diabetes
- Hypertension
- Females who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Health Systems; Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
The purpose of the study is to evaluate the ability of IVIG to affect the rate of progression of brain ischemia, as evidenced by neuroimaging.
The results of an ongoing epidemiological study indicate that patients with primary immunodeficiency (PID) on IVIG replacement therapy have an overall prevalence of stroke that is 5 times less than in the general population. Even more striking is the absence of stroke in IVIG-treated PID patients over 65, while in the same general population age group the stroke prevalence goes up to 8.1%. This suggests that the degree of stroke protection correlates with the length of IVIG treatment, since older PID patients have been treated with IVIG significantly longer than younger ones.
Read the detailed description
Two pre-clinical studies demonstrated the effectiveness of IVIG preparations in improving the clinical outcome of stroke and at the same time provided evidence of the role of complement fragments in the pathogenesis of ischemia-induced brain damage. Scavenging of these active fragments by IVIG is the likely mechanism of beneficial effect. In one of these studies CSL's own Privigen preparation was used. Considering that it exhibited in-vitro scavenging abilities more pronounced than several other IVIG preparations, and that its in-vivo scavenging capacity was also proven in a relevant animal model, a need to test this preparation in stroke patients is warranted. In addition, activation of complement and the level of activated fragments in humans seem to correlate with the severity of the disease, making them an ideal therapeutic target.
- Conditions
- Ischemic Stroke
- Being tested
- Privigen, Normal Saline
- Keywords
- IVIg, Acute Ischemic Stroke, Stroke, CVA, Cerebrovascular Accident
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrivigenBiological
Also called IVIg, Immune Globulin Intravenous (Human), Immune Globulin Intravenous (Human), 10% Liquid
10% liquid intravenous immunoglobulin at a single dose of 1.0g/kg, run at 0.5ml/kg/hr for the first 30 minutes, then increased to 2.5ml/kg/hr until complete (~3-4 hours depending on weight).
Normal SalineOther
Also called 0.9% Sodium Chloride Solution
Normal Saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. It contains no antimicrobial agents. The pH is 5.0 (4.5 to 7.0).
It contains 9 g/L Sodium Chloride with an osmolarity of 308 mOsmol/L and 154 mEq/L Sodium and Chloride.
The infusion will start at 0.5 ml/kg/hr for the first 30 minutes and then increased to 2.5 ml/kg/hr for 3-4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Privigen | Experimental | The IVIG preparation to be used is 10% liquid (Privigen). IVIG will be applied at a dose of 1.0g/kg, which is approximately 1/2 of the optimal dose used for other immuno/inflammatory indications. The infusion will start at 0.5 ml/kg/hr for the first 30 minutes, to watch for the signs of hypersensitivity to immunoglobulins, and then increased to 2.5 ml/kg/hr, two times slower than the recommended rate indicated in the product package insert (5 ml/kg/hr). Such a low, single dose has not been associated with hyperviscosity and together with a slow infusion will safeguard against occurrence of adverse events related to IVIG infusions. They will receive a total of 1g/kg and depending on patient's weight, it will take between 3.5 to 4+ hours to infuse that amount. Receives: Biological: Privigen |
| Normal Saline | Placebo comparator | The placebo is the normal saline. Since saline solution will be infused at the volume equivalent to that in which the intended dose of immunoglobulin molecules will be delivered, the placebo (comparator) arm will also serve as a control for the volume of fluid infused to the treatment arm participants. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-IVIG DWI/PI mismatch measurement
Decrease in the size of post IVIG necrotic area relative to baseline values and percent of penumbra saved, defined by neuroimaging as DWI/PI mismatch.
Measured: 3 days
Secondary outcomes (4)
Favorable clinical outcome
Favorable clinical outcome at Day 90, which requires fulfillment of all three of the following criteria: improvement in NIHSS of 8 points or more from baseline; modified Rankin scale (mRS) score of 0-2 points; and Barthel index (BI) of 75-100
Measured: 90 days
Clinical outcome measure by NIHSS
Clinical outcome measured by change in NIHSS scores will be also examined on Day 3
Measured: 3 days
Active complement fragment levels
Levels of active complement fragments, C3a, C5a, C5b-9 and C4d at Day 0 and post-IVIG and Day 90.
Measured: 90 days
Adverse Events
Incidence in adverse events.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startMar 2013
- Primary completionAug 2013 (estimated)
- Study completionSep 2013
Why it stopped: difficult recruitment and new black box warning for IVIG
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Sponsor
- Investigators
- Beverly C Walters, MD, Study director, Inova Health SystemsMilan Basta, MD, Study chair, BioVisions, Inc.Jack Cochran, MD, Principal investigator, Inova Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628055
- Sponsor's protocol ID
- IVIG/AIS-IFH-MB-CSL
- Acronym
- IVIG/AIS
- Status last verified
- Nov 2013
- First submitted
- 14 Jun 2012
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
D'Ambrosio AL, Pinsky DJ, Connolly ES. The role of the complement cascade in ischemia/reperfusion injury: implications for neuroprotection. Mol Med. 2001 Jun;7(6):367-82.
PubMed 11474130Ember JA, Hugli TE. Complement factors and their receptors. Immunopharmacology. 1997 Dec;38(1-2):3-15. doi: 10.1016/s0162-3109(97)00088-x.
PubMed 9476110de Boer JP, Wolbink GJ, Thijs LG, Baars JW, Wagstaff J, Hack CE. Interplay of complement and cytokines in the pathogenesis of septic shock. Immunopharmacology. 1992 Sep-Oct;24(2):135-48. doi: 10.1016/0162-3109(92)90019-9.
PubMed 1473964Szalai AJ, van Ginkel FW, Wang Y, McGhee JR, Volanakis JE. Complement-dependent acute-phase expression of C-reactive protein and serum amyloid P-component. J Immunol. 2000 Jul 15;165(2):1030-5. doi: 10.4049/jimmunol.165.2.1030.
PubMed 10878380Van Beek J, Bernaudin M, Petit E, Gasque P, Nouvelot A, MacKenzie ET, Fontaine M. Expression of receptors for complement anaphylatoxins C3a and C5a following permanent focal cerebral ischemia in the mouse. Exp Neurol. 2000 Jan;161(1):373-82. doi: 10.1006/exnr.1999.7273.
PubMed 10683302Lindsberg PJ, Ohman J, Lehto T, Karjalainen-Lindsberg ML, Paetau A, Wuorimaa T, Carpen O, Kaste M, Meri S. Complement activation in the central nervous system following blood-brain barrier damage in man. Ann Neurol. 1996 Oct;40(4):587-96. doi: 10.1002/ana.410400408.
PubMed 8871578Nishino H, Czurko A, Fukuda A, Hashitani T, Hida H, Karadi Z, Lenard L. Pathophysiological process after transient ischemia of the middle cerebral artery in the rat. Brain Res Bull. 1994;35(1):51-6. doi: 10.1016/0361-9230(94)90215-1.
PubMed 7953757Figueroa E, Gordon LE, Feldhoff PW, Lassiter HA. The administration of cobra venom factor reduces post-ischemic cerebral injury in adult and neonatal rats. Neurosci Lett. 2005 May 20-27;380(1-2):48-53. doi: 10.1016/j.neulet.2005.01.027. Epub 2005 Feb 2.
PubMed 15854749Arumugam TV, Tang SC, Lathia JD, Cheng A, Mughal MR, Chigurupati S, Magnus T, Chan SL, Jo DG, Ouyang X, Fairlie DP, Granger DN, Vortmeyer A, Basta M, Mattson MP. Intravenous immunoglobulin (IVIG) protects the brain against experimental stroke by preventing complement-mediated neuronal cell death. Proc Natl Acad Sci U S A. 2007 Aug 28;104(35):14104-9. doi: 10.1073/pnas.0700506104. Epub 2007 Aug 21.
PubMed 17715065Szeplaki G, Szegedi R, Hirschberg K, Gombos T, Varga L, Karadi I, Entz L, Szeplaki Z, Garred P, Prohaszka Z, Fust G. Strong complement activation after acute ischemic stroke is associated with unfavorable outcomes. Atherosclerosis. 2009 May;204(1):315-20. doi: 10.1016/j.atherosclerosis.2008.07.044. Epub 2008 Aug 14.
PubMed 18804761De Simoni MG, Rossi E, Storini C, Pizzimenti S, Echart C, Bergamaschini L. The powerful neuroprotective action of C1-inhibitor on brain ischemia-reperfusion injury does not require C1q. Am J Pathol. 2004 May;164(5):1857-63. doi: 10.1016/S0002-9440(10)63744-3.
PubMed 15111332De Simoni MG, Storini C, Barba M, Catapano L, Arabia AM, Rossi E, Bergamaschini L. Neuroprotection by complement (C1) inhibitor in mouse transient brain ischemia. J Cereb Blood Flow Metab. 2003 Feb;23(2):232-9. doi: 10.1097/01.WCB.0000046146.31247.A1.
PubMed 12571454Akita N, Nakase H, Kaido T, Kanemoto Y, Sakaki T. Protective effect of C1 esterase inhibitor on reperfusion injury in the rat middle cerebral artery occlusion model. Neurosurgery. 2003 Feb;52(2):395-400; discussion 400-1. doi: 10.1227/01.neu.0000043710.61233.b4.
PubMed 12535370Akita N, Nakase H, Kanemoto Y, Kaido T, Nishioka T, Sakaki T. [The effect of C 1 esterase inhibitor on ischemia: reperfusion injury in the rat brain]. No To Shinkei. 2001 Jul;53(7):641-4. Japanese.
PubMed 11517488Basta M, Fries LF, Frank MM. High doses of intravenous Ig inhibit in vitro uptake of C4 fragments onto sensitized erythrocytes. Blood. 1991 Jan 15;77(2):376-80.
PubMed 1985703
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVIG in Acute Ischemic Stroke: A Pilot Study
- ClinicalTrials.gov ID
- NCT01628055
- Acronym / sponsor ID
- IVIG/AIS / IVIG/AIS-IFH-MB-CSL
- Conditions
- Ischemic Stroke
- Keywords
- IVIg, Acute Ischemic Stroke, Stroke, CVA, Cerebrovascular Accident
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficult recruitment and new black box warning for IVIG
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Jun 2012 (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 the study is to evaluate the ability of IVIG to affect the rate of progression of brain ischemia, as evidenced by neuroimaging.
The results of an ongoing epidemiological study indicate that patients with primary immunodeficiency (PID) on IVIG replacement therapy have an overall prevalence of stroke that is 5 times less than in the general population. Even more striking is the absence of stroke in IVIG-treated PID patients over 65, while in the same general population age group the stroke prevalence goes up to 8.1%. This suggests that the degree of stroke protection correlates with the length of IVIG treatment, since older PID patients have been treated with IVIG significantly longer than younger ones.
Detailed description
Two pre-clinical studies demonstrated the effectiveness of IVIG preparations in improving the clinical outcome of stroke and at the same time provided evidence of the role of complement fragments in the pathogenesis of ischemia-induced brain damage. Scavenging of these active fragments by IVIG is the likely mechanism of beneficial effect. In one of these studies CSL's own Privigen preparation was used. Considering that it exhibited in-vitro scavenging abilities more pronounced than several other IVIG preparations, and that its in-vivo scavenging capacity was also proven in a relevant animal model, a need to test this preparation in stroke patients is warranted. In addition, activation of complement and the level of activated fragments in humans seem to correlate with the severity of the disease, making them an ideal therapeutic target.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Privigen | Experimental | Biological: PrivigenThe IVIG preparation to be used is 10% liquid (Privigen). IVIG will be applied at a dose of 1.0g/kg, which is approximately 1/2 of the optimal dose used for other immuno/inflammatory indications. The infusion will start at 0.5 ml/kg/hr for the first 30 minutes, to watch for the signs of hypersensitivity to immunoglobulins, and then increased to 2.5 ml/kg/hr, two times slower than the recommended rate indicated in the product package insert (5 ml/kg/hr). Such a low, single dose has not been associated with hyperviscosity and together with a slow infusion will safeguard against occurrence of adverse events related to IVIG infusions. They will receive a total of 1g/kg and depending on patient's weight, it will take between 3.5 to 4+ hours to infuse that amount. |
| Normal Saline | Placebo comparator | Other: Normal SalineThe placebo is the normal saline. Since saline solution will be infused at the volume equivalent to that in which the intended dose of immunoglobulin molecules will be delivered, the placebo (comparator) arm will also serve as a control for the volume of fluid infused to the treatment arm participants. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Onset of neurological symptoms between 4.5 and 8 hours
- Male or Female age 45 -75 years old
- Score of 10-15 points on the National Institutes of Health Stroke Scale (NIHSS) with clinical signs suggestive of ischemic stroke
- Acute brain ischemia with a distinct penumbra (at least 20%), measured by magnetic resonance perfusion imaging (PI) and diffusion-weighted imaging (DWI), in the territory of the middle cerebral artery, anterior cerebral artery, or posterior cerebral artery with a hemispheric distribution
- Ability and willingness to provide informed consent and comply with study requirements and procedures
Key exclusion criteria (15 listed)
- Eligibility for acute thrombolytic (rtPA) treatment
- Normal brain MRI
- Transient ischemic attack or rapidly improving neurological symptoms
- Previous disability
- Hemorrhagic stroke on brain MRI (T2*/SWI)
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 |
|---|---|---|
| PrivigenAlso: IVIg, Immune Globulin Intravenous (Human), Immune Globulin Intravenous (Human), 10% Liquid10% liquid intravenous immunoglobulin at a single dose of 1.0g/kg, run at 0.5ml/kg/hr for the first 30 minutes, then increased to 2.5ml/kg/hr until complete (~3-4 hours depending on weight). | Biological | Privigen |
| Normal SalineAlso: 0.9% Sodium Chloride SolutionNormal Saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. It contains no antimicrobial agents. The pH is 5.0 (4.5 to 7.0). It contains 9 g/L Sodium Chloride with an osmolarity of 308 mOsmol/L and 154 mEq/L Sodium and Chloride. The infusion will start at 0.5 ml/kg/hr for the first 30 minutes and then increased to 2.5 ml/kg/hr for 3-4 hours. | Other | Normal Saline |
Primary outcome
Post-IVIG DWI/PI mismatch measurement
Time frame: 3 days
Decrease in the size of post IVIG necrotic area relative to baseline values and percent of penumbra saved, defined by neuroimaging as DWI/PI mismatch.
4 secondary outcomes
Favorable clinical outcome
Time frame: 90 days
Clinical outcome measure by NIHSS
Time frame: 3 days
Active complement fragment levels
Time frame: 90 days
Adverse Events
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
- Background: PubMed 11474130D'Ambrosio AL, Pinsky DJ, Connolly ES. The role of the complement cascade in ischemia/reperfusion injury: implications for neuroprotection. Mol Med. 2001 Jun;7(6):367-82.
- Background: PubMed 9476110Ember JA, Hugli TE. Complement factors and their receptors. Immunopharmacology. 1997 Dec;38(1-2):3-15. doi: 10.1016/s0162-3109(97)00088-x.
- Background: PubMed 1473964de Boer JP, Wolbink GJ, Thijs LG, Baars JW, Wagstaff J, Hack CE. Interplay of complement and cytokines in the pathogenesis of septic shock. Immunopharmacology. 1992 Sep-Oct;24(2):135-48. doi: 10.1016/0162-3109(92)90019-9.
- Background: PubMed 10878380Szalai AJ, van Ginkel FW, Wang Y, McGhee JR, Volanakis JE. Complement-dependent acute-phase expression of C-reactive protein and serum amyloid P-component. J Immunol. 2000 Jul 15;165(2):1030-5. doi: 10.4049/jimmunol.165.2.1030.
- Background: PubMed 10683302Van Beek J, Bernaudin M, Petit E, Gasque P, Nouvelot A, MacKenzie ET, Fontaine M. Expression of receptors for complement anaphylatoxins C3a and C5a following permanent focal cerebral ischemia in the mouse. Exp Neurol. 2000 Jan;161(1):373-82. doi: 10.1006/exnr.1999.7273.
- Background: PubMed 8871578Lindsberg PJ, Ohman J, Lehto T, Karjalainen-Lindsberg ML, Paetau A, Wuorimaa T, Carpen O, Kaste M, Meri S. Complement activation in the central nervous system following blood-brain barrier damage in man. Ann Neurol. 1996 Oct;40(4):587-96. doi: 10.1002/ana.410400408.
- Background: PubMed 7953757Nishino H, Czurko A, Fukuda A, Hashitani T, Hida H, Karadi Z, Lenard L. Pathophysiological process after transient ischemia of the middle cerebral artery in the rat. Brain Res Bull. 1994;35(1):51-6. doi: 10.1016/0361-9230(94)90215-1.
- Background: PubMed 15854749Figueroa E, Gordon LE, Feldhoff PW, Lassiter HA. The administration of cobra venom factor reduces post-ischemic cerebral injury in adult and neonatal rats. Neurosci Lett. 2005 May 20-27;380(1-2):48-53. doi: 10.1016/j.neulet.2005.01.027. Epub 2005 Feb 2.
- Background: PubMed 17715065Arumugam TV, Tang SC, Lathia JD, Cheng A, Mughal MR, Chigurupati S, Magnus T, Chan SL, Jo DG, Ouyang X, Fairlie DP, Granger DN, Vortmeyer A, Basta M, Mattson MP. Intravenous immunoglobulin (IVIG) protects the brain against experimental stroke by preventing complement-mediated neuronal cell death. Proc Natl Acad Sci U S A. 2007 Aug 28;104(35):14104-9. doi: 10.1073/pnas.0700506104. Epub 2007 Aug 21.
- Background: PubMed 18804761Szeplaki G, Szegedi R, Hirschberg K, Gombos T, Varga L, Karadi I, Entz L, Szeplaki Z, Garred P, Prohaszka Z, Fust G. Strong complement activation after acute ischemic stroke is associated with unfavorable outcomes. Atherosclerosis. 2009 May;204(1):315-20. doi: 10.1016/j.atherosclerosis.2008.07.044. Epub 2008 Aug 14.
- Background: PubMed 15111332De Simoni MG, Rossi E, Storini C, Pizzimenti S, Echart C, Bergamaschini L. The powerful neuroprotective action of C1-inhibitor on brain ischemia-reperfusion injury does not require C1q. Am J Pathol. 2004 May;164(5):1857-63. doi: 10.1016/S0002-9440(10)63744-3.
- Background: PubMed 12571454De Simoni MG, Storini C, Barba M, Catapano L, Arabia AM, Rossi E, Bergamaschini L. Neuroprotection by complement (C1) inhibitor in mouse transient brain ischemia. J Cereb Blood Flow Metab. 2003 Feb;23(2):232-9. doi: 10.1097/01.WCB.0000046146.31247.A1.
Related trials for Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
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.
Beverly C Walters, MD study director
Inova Health Systems
Milan Basta, MD study chair
BioVisions, Inc.
Jack Cochran, MD principal investigator
Inova Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Privigen and Normal Saline in people with Ischemic Stroke, run by Inova Health Care Services at 1 site in United States.
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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Post-IVIG DWI/PI mismatch measurement (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01628055, which also lists 34 linked publications.
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 11 Nov 2013.