Ischemic StrokePhase 2CLEAR-ERNCT00894803
Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke
A Phase 2 study testing Eptifibatide and rt-PA in people with Ischemic Stroke and Stroke, run by University of Cincinnati at 20 sites in United States.
Trial summary
The primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a medium dose of IV rt-PA plus IV eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke, Stroke, Brain Infarction
- What is being tested?
- Eptifibatide and rt-PA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 20 sitesUnited States
- Study dates
- Jul 2009to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a serious measurable neurological deficit on the NIH Stroke Scale due to focal brain ischemia.
- An NIH Stroke Scale score >5 at the time the rt-PA is begun.
- Age: 18 through 85 years (i.e. candidates must have had their 18th birthday, but not had their 86th birthday).
- Intravenous rt-PA therapy must be initiated within 3 hours of onset of stroke symptoms.
Who cannot join
- History of stroke in the past 3 months.
- Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation.
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal.
- Hypertension at time of treatment; systolic BP > 185 or diastolic > 110 mmHg or aggressive measures to lower blood pressure to below these limits are needed.
- Presumed septic embolus.
- Presumed pericarditis including pericarditis after acute myocardial infarction.
Show all 25Show fewer
- Recent (within 30 days) surgery or biopsy of parenchymal organ.
- Recent (within 30 days) trauma, with internal injuries or ulcerative wounds.
- Recent (within 90 days) severe head trauma or head trauma with loss of consciousness.
- Any active or recent (within 30 days) serious systemic hemorrhage.
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with Iinternational Normalized Ratio (INR) > 1.7.
- Baseline lab values: positive urine pregnancy test, glucose < 50 or > 400 mg/dl, platelets <100,000 /mm3, Hct (hematocrit) <25 %, or creatinine > 4 mg/dl.
- Ongoing renal dialysis, regardless of creatinine.
- If heparin has been administered within 48 hours, the patient must have a normal partial thromboplastin time (PTT).
- Arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days.
- Seizure at onset of stroke.
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
- Other serious, advanced, or terminal illness or any other condition that the investigator feels would pose a significant hazard to the patient if rt-PA or eptifibatide therapy were initiated.
- Patients whose peripheral venous access is so poor that they are unable to have two standard peripheral intravenous lines started.
- Current participation in another research drug treatment protocol. Patient cannot start another experimental agent until after 90 days.
- Informed consent is not or cannot be obtained.
- Any known history of amyloid angiopathy.
- High density lesion consistent with hemorrhage of any degree.
- Significant mass effect with midline shift.
- Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan. Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Mission Hospital, Inc.
Asheville, North Carolina, 28801
Suburban Hospital
Bethesda, Maryland, 20814
The Christ Hospital
Cincinnati, Ohio, 45219
University Hospital
Cincinnati, Ohio, 45219
Good Samaritan Hospital
Cincinnati, Ohio, 45220-2489
The Jewish Hospital
Cincinnati, Ohio, 45236
Mercy Hospital, Western Hills
Cincinnati, Ohio, 45238
Mercy Hospital Mt Airy
Cincinnati, Ohio, 45239
Bethesda North Hospital
Cincinnati, Ohio, 45242
St. Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017
St. Elizabeth Healthcare Florence
Florence, Kentucky, 41042
St. Elizabeth Healthcare Ft. Thomas
Fort Thomas, Kentucky, 41075
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90024
West Virginia University Hospital
Morgantown, West Virginia, 26506
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California San Diego
San Diego, California, 92103
UCLA Medical Center Santa Monica
Santa Monica, California, 90404
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: The "Combined Approach to Lysis Utilizing Eptifibatide and Rt-PA in Acute Ischemic Stroke-Enhanced Regimen" (CLEAR-ER Stroke Trial)
The primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a medium dose of IV rt-PA plus IV eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone.
Read the detailed description
The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA (recombinant tissue plasminogen activator) in Acute Ischemic Stroke-Enhanced Regimen (CLEAR-ER Stroke) trial is a Phase II trial and part of the Specialized Program on Translational Research in Acute Stroke (SPOTRIAS). The overall goals of SPOTRIAS are to enhance delivery of acute stroke patient care and train acute stroke translational researchers.
Stroke most often occurs when blood flow to the brain stops because it is blocked by a blood clot. When a blood clot blocks the blood supply to the brain, parts of the brain may not get enough blood and oxygen to survive. As a result, permanent brain damage can occur, which can affect a person's ability to walk, talk, and function independently. In order to reduce the risk of permanent damage, it is important to restore blood flow to the brain as quickly as possible.
rt-PA, used alone, is already approved by the Food and Drug Administration (FDA) as treatment for patients with a stroke caused by blockage of an artery in the brain and when given within 3 hours of the onset of stroke symptoms. Eptifibatide is also already FDA-approved as a treatment for blood clots causing heart attack. The investigational aspect of this study is the use of eptifibatide for a stroke victim in combination with rt-PA.
The CLEAR Stroke Trial (NCT00250991) demonstrated that the combination of low dose rt-PA plus eptifibatide can be safely given to acute ischemic stroke patients within 3 hours of symptom onset.
The CLEAR-ER Stroke Trial is designed to provide data concerning the risks and benefits of combining eptifibatide with medium dose intravenous rt-PA in 126 acute ischemic stroke patients within 3 hours of symptom onset. Patients will be randomized to a combined intravenous medium-dose rt-PA and eptifibatide regimen, or standard dose rt-PA in a 5 to 1 ratio. This will result in a total of 105 patients treated with a combined regimen, and 21 patients treated with standard dose IV rt-PA alone.
- Conditions
- Ischemic Stroke, Stroke, Brain Infarction
- Being tested
- Eptifibatide, rt-PA
- Keywords
- acute ischemic stroke, stroke, rt-PA, thrombolytic, t-PA, recombinant tissue plasminogen activator, Activase, eptifibatide, Integrilin, fibrinolytic agents, clot dissolving, blood clot
- Medical subject headings
- Ischemic Stroke, Stroke, Brain Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EptifibatideDrug
Also called Integrilin
IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
rt-PADrug
Also called Activase
Intravenous recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy.
| Study group | Role | What they receive |
|---|---|---|
| rt-PA only | Active comparator | Subject will receive the standard dose (0.9mg/kg) of IV rt-PA given over 60 minutes. One out of 6 subjects will be in this group. Receives: Drug: rt-PA |
| rt-PA and Eptifibatide | Experimental | Subject will receive the standard dose (0.9mg/kg) of IV rt-PA. This IV dose will be discontinued at 40 minutes. The subject will immediately receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Five out of six subjects will be in this group. Receives: Drug: Eptifibatide; Drug: rt-PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours of Treatment Onset
Primary safety outcome measure - Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator
Measured: Within 36 hours of initiation of therapy
Modified Rankin Scale (mRS) Score <1 or Return to mRS Baseline
Primary efficacy outcome measure - Modified Rankin Scale of 0 or 1 or return to the pre-stroke value at baseline or better. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of '6', and assigned the "bad" outcome. Also those lost to follow-up were assigned the "bad" outcome.
The Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care).
Measured: 90 days from treatment onset
Secondary outcomes (2)
Barthel Index ≥ 95
Barthel index score of ≥ 95. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the "bad" outcome.
The Barthel index is a score comprised of 10 individual items. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The individual items are summed to produce a total score between 0 and 100; where 0 is inferior performance and 100 is optimal. A score of ≥ 95 is usually considered excellent.
Measured: 90 days from treatment onset
Glasgow Outcome Scale (GOS) of 1
Glasgow outcome scale score of 1 versus greater than 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the "bad" outcome.
The Glasgow Outcome Scale is scored; 1=good recovery, 2=moderately disabled, 3=severely disabled, 4=vegetative survival, 5=dead.
Measured: 90 days from treatment onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Pancioli, University of Cincinnati
- Investigators
- Arthur M Pancioli, MD, Principal investigator, University of Cincinnati College of Medicine Department of Emergency MedicineOpeolu M Adeoye, MD, Principal investigator, University of Cincinnati College of Medicine Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894803
- Sponsor's protocol ID
- P50NS04483-06
- Other IDs
- 00894803
- Acronym
- CLEAR-ER
- Status last verified
- Mar 2014
- First submitted
- 6 May 2009
- Last updated
- 17 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Barreto AD, Pedroza C, Grotta JC. Adjunctive medical therapies for acute stroke thrombolysis: is there a CLEAR-ER choice? Stroke. 2013 Sep;44(9):2377-9. doi: 10.1161/STROKEAHA.113.001830. Epub 2013 Jul 25. No abstract available.
PubMed 23887845Pancioli AM, Adeoye O, Schmit PA, Khoury J, Levine SR, Tomsick TA, Sucharew H, Brooks CE, Crocco TJ, Gutmann L, Hemmen TM, Kasner SE, Kleindorfer D, Knight WA, Martini S, McKinney JS, Meurer WJ, Meyer BC, Schneider A, Scott PA, Starkman S, Warach S, Broderick JP; CLEAR-ER Investigators. Combined approach to lysis utilizing eptifibatide and recombinant tissue plasminogen activator in acute ischemic stroke-enhanced regimen stroke trial. Stroke. 2013 Sep;44(9):2381-7. doi: 10.1161/STROKEAHA.113.001059. Epub 2013 Jul 25.
PubMed 23887841
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Combined Approach to Lysis Utilizing Eptifibatide and Rt-PA in Acute Ischemic Stroke-Enhanced Regimen" (CLEAR-ER Stroke Trial)
- ClinicalTrials.gov ID
- NCT00894803
- Acronym / sponsor ID
- CLEAR-ER / P50NS04483-06
- Conditions
- Ischemic Stroke, Stroke, Brain Infarction
- Keywords
- acute ischemic stroke, stroke, rt-PA, thrombolytic, t-PA, recombinant tissue plasminogen activator, Activase, eptifibatide, Integrilin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jul 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Posted 17 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a medium dose of IV rt-PA plus IV eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone.
Detailed description
The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA (recombinant tissue plasminogen activator) in Acute Ischemic Stroke-Enhanced Regimen (CLEAR-ER Stroke) trial is a Phase II trial and part of the Specialized Program on Translational Research in Acute Stroke (SPOTRIAS). The overall goals of SPOTRIAS are to enhance delivery of acute stroke patient care and train acute stroke translational researchers.
Stroke most often occurs when blood flow to the brain stops because it is blocked by a blood clot. When a blood clot blocks the blood supply to the brain, parts of the brain may not get enough blood and oxygen to survive. As a result, permanent brain damage can occur, which can affect a person's ability to walk, talk, and function independently. In order to reduce the risk of permanent damage, it is important to restore blood flow to the brain as quickly as possible.
rt-PA, used alone, is already approved by the Food and Drug Administration (FDA) as treatment for patients with a stroke caused by blockage of an artery in the brain and when given within 3 hours of the onset of stroke symptoms. Eptifibatide is also already FDA-approved as a treatment for blood clots causing heart attack. The investigational aspect of this study is the use of eptifibatide for a stroke victim in combination with rt-PA.
The CLEAR Stroke Trial (NCT00250991) demonstrated that the combination of low dose rt-PA plus eptifibatide can be safely given to acute ischemic stroke patients within 3 hours of symptom onset.
The CLEAR-ER Stroke Trial is designed to provide data concerning the risks and benefits of combining eptifibatide with medium dose intravenous rt-PA in 126 acute ischemic stroke patients within 3 hours of symptom onset. Patients will be randomized to a combined intravenous medium-dose rt-PA and eptifibatide regimen, or standard dose rt-PA in a 5 to 1 ratio. This will result in a total of 105 patients treated with a combined regimen, and 21 patients treated with standard dose IV rt-PA alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rt-PA only | Active comparator | Drug: rt-PASubject will receive the standard dose (0.9mg/kg) of IV rt-PA given over 60 minutes. One out of 6 subjects will be in this group. |
| rt-PA and Eptifibatide | Experimental | Drug: Eptifibatide, Drug: rt-PASubject will receive the standard dose (0.9mg/kg) of IV rt-PA. This IV dose will be discontinued at 40 minutes. The subject will immediately receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Five out of six subjects will be in this group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have a serious measurable neurological deficit on the NIH Stroke Scale due to focal brain ischemia.
- An NIH Stroke Scale score >5 at the time the rt-PA is begun.
- Age: 18 through 85 years (i.e. candidates must have had their 18th birthday, but not had their 86th birthday).
- Intravenous rt-PA therapy must be initiated within 3 hours of onset of stroke symptoms.
Key exclusion criteria (25 listed)
- History of stroke in the past 3 months.
- Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation.
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal.
- Hypertension at time of treatment; systolic BP > 185 or diastolic > 110 mmHg or aggressive measures to lower blood pressure to below these limits are needed.
- Presumed septic embolus.
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 |
|---|---|---|
| EptifibatideAlso: IntegrilinIV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen. | Drug | rt-PA and Eptifibatide |
| rt-PAAlso: ActivaseIntravenous recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy. | Drug | rt-PA and Eptifibatide, rt-PA only |
Primary outcome
Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours of Treatment Onset
Time frame: Within 36 hours of initiation of therapy
Primary safety outcome measure - Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator
Modified Rankin Scale (mRS) Score <1 or Return to mRS Baseline
Time frame: 90 days from treatment onset
Primary efficacy outcome measure - Modified Rankin Scale of 0 or 1 or return to the pre-stroke value at baseline or better. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of '6', and assigned the "bad" outcome. Also those lost to follow-up were assigned the "bad" outcome. The Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care).
2 secondary outcomes
Barthel Index ≥ 95
Time frame: 90 days from treatment onset
Glasgow Outcome Scale (GOS) of 1
Time frame: 90 days from treatment onset
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23887845Barreto AD, Pedroza C, Grotta JC. Adjunctive medical therapies for acute stroke thrombolysis: is there a CLEAR-ER choice? Stroke. 2013 Sep;44(9):2377-9. doi: 10.1161/STROKEAHA.113.001830. Epub 2013 Jul 25. No abstract available.
- Results publication: PubMed 23887841Pancioli AM, Adeoye O, Schmit PA, Khoury J, Levine SR, Tomsick TA, Sucharew H, Brooks CE, Crocco TJ, Gutmann L, Hemmen TM, Kasner SE, Kleindorfer D, Knight WA, Martini S, McKinney JS, Meurer WJ, Meyer BC, Schneider A, Scott PA, Starkman S, Warach S, Broderick JP; CLEAR-ER Investigators. Combined approach to lysis utilizing eptifibatide and recombinant tissue plasminogen activator in acute ischemic stroke-enhanced regimen stroke trial. Stroke. 2013 Sep;44(9):2381-7. doi: 10.1161/STROKEAHA.113.001059. Epub 2013 Jul 25.
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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.
Arthur M Pancioli, MD principal investigator
University of Cincinnati College of Medicine Department of Emergency Medicine
Opeolu M Adeoye, MD principal investigator
University of Cincinnati College of Medicine Department of Emergency Medicine
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eptifibatide and rt-PA in people with Ischemic Stroke and Stroke, run by University of Cincinnati at 20 sites 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 4 inclusion and 25 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 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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. 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?
Yes. Results are posted in the registry (first posted 17 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours of Treatment Onset (time frame: Within 36 hours of initiation of therapy). The study lists 2 primary outcomes in all. 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 NCT00894803, which also lists 2 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 17 Apr 2014.