Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)
Study Details
Study Description
Brief Summary
The purpose of this study is to determine which of 3 different doses of tenecteplase (TNK) is better for treating stroke patients and if TNK offers an advantage over currently available treatment with tissue plasminogen activator (tPA).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Stroke is the third leading cause of death and a leading cause of adult disability in the United States and worldwide. To date, the only scientifically-proven and FDA-approved treatment for acute stroke is the clot-busting drug, tissue plasminogen activator (tPA). A newer clot-busting drug, tenecteplase (TNK), has chemical properties that make it a potentially safer and more effective drug for treating stroke. Preliminary testing of TNK in patients with acute stroke has been encouraging enough to warrant further testing.
This study, TNK-S2B, will compare three different doses of TNK with standard tPA treatment in patients with acute stroke. Patients will be chosen randomly to receive either TNK or tPA. Neither the patient nor his/her doctor will know which medication the patient received until the study is completely finished.
The first part of the study will look at results of treatment in the first 24 hours to select the best dose of TNK to carry forward into a more detailed comparison with standard tPA treatment. After at least 100-150 pairs of the best dose of TNK and tPA patients have been enrolled, entry into the study will pause, and the outcomes at 3 months after stroke will be compared to see if the results of TNK treatment are sufficiently promising as an improvement over standard treatment to justify expanding the study to find a definitive answer.
The study, which will be conducted in at least 8 large medical centers, is expected to last about 3 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 tenecteplase |
Drug: tenecteplase
This study will compare 3 different doses of tenecteplase to tPA.
Other Names:
|
| Active Comparator: 2 tissue plasminogen activator, tPA |
Drug: tissue plasminogen activator, tPA
To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Functional Handicap (Modified Rankin Score) [3 months]
The scale range is from 0 (perfect health without symptoms) to 6 (death). Percentage of participants with Modified Rankin Score >=4 are reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with at least a serious, measurable deficit on the NIH Stroke Scale in language (aphasia score > 1), motor power (arm or leg > 1), vision (best visual score
2), or attention (attention score > 2). Thus eligible patients may have a minimum total score of 1 if the deficit is in language or motor power. There is no maximum score that is exclusionary; even patients with severe hemispheric or brainstem deficits will be eligible, as is current practice with intravenous rt-PA. Patients with all ischemic stroke types and in all vascular distributions are eligible.
-
Must arrive at participating hospital and treatment begun within 3 hours of the onset of symptoms. Patients awakening with new symptoms must use the time last observed to be normal and awake and the total time cannot exceed three hours prior to treatment as the time of onset.
-
Must be 18 years of age or older.
Exclusion Criteria:
-
Patients with a) minor stroke symptoms (e.g., sensory loss, ataxia, dysarthria, or facial weakness alone) or b) major symptoms which are rapidly improving by the time of treatment.
-
Patients for whom a complete NIH Stroke Score cannot be obtained (e.g., intubated patients or complete amputees).
-
Patients with evidence of intracranial hemorrhage on pretreatment CT scan.
-
Patients with a clinical presentation that suggests subarachnoid hemorrhage, even if the initial CT scan is normal.
-
Patients who are known or suspected to be pregnant.
-
Patients with a known bleeding diathesis or patients with a platelet count < 100,000. For patients who are taking oral Warfarin (Coumadin), the results of the pretreatment International Normalized Ratio (INR) must be available prior to treatment and must be
-
</= 1.4. Patients who have received heparin within 48 hours must have a normal partial thromboplastin time (PTT) to be eligible. Patients who have received low molecular weight heparin or heparinoid within 24 hours are also excluded.
-
Patients with major surgery or serious trauma excluding head trauma within 14 days or serious head trauma within 3 months.
-
Patients with a history of gastrointestinal or urinary tract hemorrhage in the previous 21 days.
-
Patients with an arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days.
-
Patients who, on repeated measurement, have a systolic blood pressure > 185, or a diastolic blood pressure > 110 mmHg when treatment is to begin, or require aggressive treatment to reduce blood pressure to within these limits.
-
Patients with a history of stroke in the previous 3 months or have ever had an intracranial hemorrhage considered to put them at increased risk for intracranial hemorrhage.
-
Patients with a serious medical illness likely to interfere with treatment or treatment might adversely affect that illness.
-
Patients with abnormal blood glucose thought to account for the neurological deficit.
-
Patients with a clinical presentation consistent with acute myocardial infarction or patients with presentation suggesting post-myocardial infarction pericarditis.
-
Patients with a seizure at onset of stroke thought to be presenting with post-ictal paralysis mimicking stroke.
-
Patients with pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
-
Patients who have received any other investigational drug within 14 days.
-
Patients who have large areas (greater than one lobe) of obvious low density on the baseline CT scan will be presumed to have had ongoing cerebral ischemia for greater than 3 hours, and will, therefore, be excluded. Patients with subtle early signs of cerebral infarction (e.g., sulcal effacement, blurring of the grey-white junction, asymmetry of the basal ganglia, insular ribbon sign, and others) and the dense artery sign on baseline CT scan will be eligible. Similarly, evidence of previous remote cerebral infarction on baseline CT will not be exclusionary.
-
Patients for whom informed consent cannot be obtained.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California at San Diego | San Diego | California | United States | 92103-8466 |
| 2 | Colorado Neurological Institutes | Englewood | Colorado | United States | 80113-2771 |
| 3 | Johns Hopkins-Bayview Medical Center | Baltimore | Maryland | United States | 21224 |
| 4 | University of Michigan | Ann Arbor | Michigan | United States | 48109-0316 |
| 5 | Long Island Jewish Hospital | New Hyde Park | New York | United States | 11040 |
| 6 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 7 | Columbia University, Statistical Analysis Center | New York | New York | United States | 10032 |
| 8 | University of Texas at Houston | Houston | Texas | United States | 77030 |
| 9 | University of Virginia Health System | Charlottesville | Virginia | United States | 22908 |
Sponsors and Collaborators
- University of Virginia
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
- Principal Investigator: E. Clarke Haley, Jr., M.D., Clinical Coordinating Center, Department of Neurology, University of Virginia Health System
- Principal Investigator: John L. P. Thompson, Ph.D., Statistical Analysis Center, Department of Biostatistics, Mailman School of Public Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 11231
- R01NS045170
- R01NS037666
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | TNK 0.1 mg/kg | TNK 0.25 mg/kg | TNK 0.4 mg/kg | tPA 0.9 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | Lowest dose tenecteplase | Medium dose tenecteplase | Highest dose tenecteplase | tissue plasminogen activator, tPA tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke. |
| Period Title: Overall Study | ||||
| STARTED | 31 | 31 | 19 | 31 |
| COMPLETED | 30 | 31 | 17 | 30 |
| NOT COMPLETED | 1 | 0 | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | TNK 0.1 mg/kg | TNK 0.25 mg/kg | TNK 0.4 mg/kg | tPA 0.9 mg/kg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Lowest dose tenecteplase | Medium dose tenecteplase | Highest dose tenecteplase | tissue plasminogen activator, tPA tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke. | Total of all reporting groups |
| Overall Participants | 31 | 31 | 19 | 31 | 112 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
67
(19)
|
69
(15)
|
68
(16)
|
72
(16)
|
69
(17)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
19
61.3%
|
15
48.4%
|
6
31.6%
|
14
45.2%
|
54
48.2%
|
| Male |
12
38.7%
|
16
51.6%
|
13
68.4%
|
17
54.8%
|
58
51.8%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
3.2%
|
2
10.5%
|
0
0%
|
3
2.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
16.1%
|
4
12.9%
|
4
21.1%
|
5
16.1%
|
18
16.1%
|
| White |
24
77.4%
|
26
83.9%
|
12
63.2%
|
25
80.6%
|
87
77.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
6.5%
|
0
0%
|
1
5.3%
|
1
3.2%
|
4
3.6%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
31
100%
|
31
100%
|
19
100%
|
31
100%
|
112
100%
|
Outcome Measures
| Title | Functional Handicap (Modified Rankin Score) |
|---|---|
| Description | The scale range is from 0 (perfect health without symptoms) to 6 (death). Percentage of participants with Modified Rankin Score >=4 are reported. |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | TNK 0.1 mg/kg | TNK 0.25 mg/kg | TNK 0.4 mg/kg | tPA 0.9 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | Lowest dose tenecteplase | Medium dose tenecteplase | Highest dose tenecteplase | tissue plasminogen activator, tPA tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke. |
| Measure Participants | 31 | 31 | 19 | 30 |
| Number [percentage of participants] |
22.6
72.9%
|
35.5
114.5%
|
31.6
166.3%
|
32.3
104.2%
|
Adverse Events
| Time Frame | 3 months | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | TNK 0.1 mg/kg | TNK 0.25 mg/kg | TNK 0.4 mg/kg | tPA 0.9 mg/kg | ||||
| Arm/Group Description | Lowest dose tenecteplase | Medium dose tenecteplase | Highest dose tenecteplase | tissue plasminogen activator, tPA tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke. | ||||
All Cause Mortality |
||||||||
| TNK 0.1 mg/kg | TNK 0.25 mg/kg | TNK 0.4 mg/kg | tPA 0.9 mg/kg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| TNK 0.1 mg/kg | TNK 0.25 mg/kg | TNK 0.4 mg/kg | tPA 0.9 mg/kg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/31 (41.9%) | 25/31 (80.6%) | 13/19 (68.4%) | 26/31 (83.9%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Reduced hemoglobin | 1/31 (3.2%) | 1 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 0/31 (0%) | 0 |
| Cardiac disorders | ||||||||
| Cardiac ischemia/infarction | 1/31 (3.2%) | 1 | 2/31 (6.5%) | 2 | 1/19 (5.3%) | 1 | 1/31 (3.2%) | 1 |
| Supraventricular and nodal arrhythmia | 2/31 (6.5%) | 2 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 2/31 (6.5%) | 2 |
| Cardiac General | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 2/31 (6.5%) | 2 |
| Left ventricular systolic dysfunction | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 1/19 (5.3%) | 1 | 0/31 (0%) | 0 |
| Valvular heart disease | 0/31 (0%) | 0 | 1/31 (3.2%) | 1 | 0/19 (0%) | 0 | 0/31 (0%) | 0 |
| Ventricular arrhythmia | 0/31 (0%) | 0 | 1/31 (3.2%) | 1 | 0/19 (0%) | 0 | 0/31 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Dysphagia | 0/31 (0%) | 0 | 1/31 (3.2%) | 1 | 0/19 (0%) | 0 | 0/31 (0%) | 0 |
| Malignancy | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 1/31 (3.2%) | 1 |
| General disorders | ||||||||
| Hemorrhage/Bleeding - other | 0/31 (0%) | 0 | 1/31 (3.2%) | 1 | 0/19 (0%) | 0 | 0/31 (0%) | 0 |
| Infection with unknown ANC | 1/31 (3.2%) | 1 | 1/31 (3.2%) | 1 | 3/19 (15.8%) | 3 | 1/31 (3.2%) | 1 |
| Death not associated with CTCAE term | 0/31 (0%) | 0 | 2/31 (6.5%) | 2 | 0/19 (0%) | 0 | 0/31 (0%) | 0 |
| Infections and infestations | ||||||||
| Infection with Grade 3 or 4 neutrophils | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 1/19 (5.3%) | 1 | 0/31 (0%) | 0 |
| Infection with normal, Grade 1 or 2 neutrophils | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 1/19 (5.3%) | 1 | 0/31 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Sodium, serum high (hypernatremia | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 1/19 (5.3%) | 1 | 0/31 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Fracture | 0/31 (0%) | 0 | 1/31 (3.2%) | 1 | 0/19 (0%) | 0 | 1/31 (3.2%) | 1 |
| Musculoskeletal/soft tissue - other | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 1/31 (3.2%) | 1 |
| Nervous system disorders | ||||||||
| Hemorrhage, CNS | 0/31 (0%) | 0 | 2/31 (6.5%) | 2 | 3/19 (15.8%) | 3 | 1/31 (3.2%) | 1 |
| Somnolence/depressed level of consciousness | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 2/31 (6.5%) | 2 |
| Neurology-other | 0/31 (0%) | 0 | 1/31 (3.2%) | 1 | 0/19 (0%) | 0 | 0/31 (0%) | 0 |
| Seizure | 0/31 (0%) | 0 | 1/31 (3.2%) | 1 | 0/19 (0%) | 0 | 0/31 (0%) | 0 |
| CNS ischemia | 5/31 (16.1%) | 5 | 7/31 (22.6%) | 7 | 5/19 (26.3%) | 5 | 7/31 (22.6%) | 7 |
| Renal and urinary disorders | ||||||||
| Renal failure | 0/31 (0%) | 0 | 1/31 (3.2%) | 1 | 1/19 (5.3%) | 1 | 2/31 (6.5%) | 2 |
| Elevated creatinine | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 1/31 (3.2%) | 1 |
| Urinary frequency/urgency | 1/31 (3.2%) | 1 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 0/31 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Hypoxia | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 1/19 (5.3%) | 1 | 1/31 (3.2%) | 1 |
| Adult Respiratory Distress Syndrome | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 1/19 (5.3%) | 1 | 0/31 (0%) | 0 |
| Aspiration | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 1/31 (3.2%) | 1 |
| Pleural effusion (non-malignant) | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 1/19 (5.3%) | 1 | 0/31 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Ulceration | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 1/31 (3.2%) | 1 |
| Surgical and medical procedures | ||||||||
| Vessel injury - artery | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 1/31 (3.2%) | 1 |
| Vascular disorders | ||||||||
| Vascular - other | 1/31 (3.2%) | 1 | 2/31 (6.5%) | 2 | 1/19 (5.3%) | 1 | 0/31 (0%) | 0 |
| Hypotension | 1/31 (3.2%) | 1 | 1/31 (3.2%) | 1 | 0/19 (0%) | 0 | 0/31 (0%) | 0 |
| Thrombosis/thrombus/embolism | 0/31 (0%) | 0 | 0/31 (0%) | 0 | 0/19 (0%) | 0 | 1/31 (3.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| TNK 0.1 mg/kg | TNK 0.25 mg/kg | TNK 0.4 mg/kg | tPA 0.9 mg/kg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 25/31 (80.6%) | 24/31 (77.4%) | 17/19 (89.5%) | 20/31 (64.5%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Blood/Bone marrow - other | 5/31 (16.1%) | 5 | 6/31 (19.4%) | 6 | 5/19 (26.3%) | 5 | 5/31 (16.1%) | 5 |
| Hemoglobin low | 4/31 (12.9%) | 4 | 9/31 (29%) | 9 | 4/19 (21.1%) | 4 | 4/31 (12.9%) | 4 |
| Lymphopenia | 2/31 (6.5%) | 2 | 4/31 (12.9%) | 4 | 2/19 (10.5%) | 2 | 2/31 (6.5%) | 2 |
| Neutrophils/granulocytes high | 1/31 (3.2%) | 1 | 2/31 (6.5%) | 2 | 2/19 (10.5%) | 2 | 1/31 (3.2%) | 1 |
| Cardiac disorders | ||||||||
| Valvular heart disease | 2/31 (6.5%) | 2 | 3/31 (9.7%) | 3 | 1/19 (5.3%) | 1 | 3/31 (9.7%) | 3 |
| Cardiac general - other | 2/31 (6.5%) | 2 | 2/31 (6.5%) | 2 | 2/19 (10.5%) | 2 | 2/31 (6.5%) | 2 |
| Gastrointestinal disorders | ||||||||
| Constipation | 3/31 (9.7%) | 3 | 4/31 (12.9%) | 4 | 3/19 (15.8%) | 3 | 1/31 (3.2%) | 1 |
| Hemorrhage, GI | 1/31 (3.2%) | 1 | 1/31 (3.2%) | 1 | 4/19 (21.1%) | 4 | 1/31 (3.2%) | 1 |
| General disorders | ||||||||
| Pain | 14/31 (45.2%) | 14 | 8/31 (25.8%) | 8 | 6/19 (31.6%) | 6 | 4/31 (12.9%) | 4 |
| Nausea | 3/31 (9.7%) | 3 | 3/31 (9.7%) | 3 | 3/19 (15.8%) | 3 | 2/31 (6.5%) | 2 |
| Fever, in the absence of neutropenia | 1/31 (3.2%) | 1 | 2/31 (6.5%) | 2 | 2/19 (10.5%) | 2 | 2/31 (6.5%) | 2 |
| Metabolism and nutrition disorders | ||||||||
| Potassium, serum low | 5/31 (16.1%) | 5 | 6/31 (19.4%) | 6 | 4/19 (21.1%) | 4 | 3/31 (9.7%) | 3 |
| Metabolic/laboratory - other | 5/31 (16.1%) | 5 | 3/31 (9.7%) | 3 | 3/19 (15.8%) | 3 | 4/31 (12.9%) | 4 |
| Glucose, serum-high | 2/31 (6.5%) | 2 | 3/31 (9.7%) | 3 | 4/19 (21.1%) | 4 | 2/31 (6.5%) | 2 |
| Calcium, serum low | 2/31 (6.5%) | 2 | 4/31 (12.9%) | 4 | 1/19 (5.3%) | 1 | 3/31 (9.7%) | 3 |
| Albumin, serum low | 3/31 (9.7%) | 3 | 2/31 (6.5%) | 2 | 1/19 (5.3%) | 1 | 3/31 (9.7%) | 3 |
| Magnesium, serum low | 1/31 (3.2%) | 1 | 2/31 (6.5%) | 2 | 2/19 (10.5%) | 2 | 1/31 (3.2%) | 1 |
| Pancreatic endocrine: glucose intolerance | 2/31 (6.5%) | 2 | 0/31 (0%) | 0 | 3/19 (15.8%) | 3 | 1/31 (3.2%) | 1 |
| Nervous system disorders | ||||||||
| Hemorrhage, CNS | 0/31 (0%) | 0 | 4/31 (12.9%) | 4 | 4/19 (21.1%) | 4 | 2/31 (6.5%) | 2 |
| Psychiatric disorders | ||||||||
| Mood alteration | 1/31 (3.2%) | 1 | 5/31 (16.1%) | 5 | 2/19 (10.5%) | 2 | 2/31 (6.5%) | 2 |
| Renal and urinary disorders | ||||||||
| Hemorrhage, GU | 0/31 (0%) | 0 | 1/31 (3.2%) | 1 | 4/19 (21.1%) | 4 | 3/31 (9.7%) | 3 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Atelectasis | 1/31 (3.2%) | 1 | 2/31 (6.5%) | 2 | 3/19 (15.8%) | 3 | 1/31 (3.2%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Bruising in absence of grade 3 or 4 thrombocytopenia | 2/31 (6.5%) | 2 | 7/31 (22.6%) | 7 | 2/19 (10.5%) | 2 | 5/31 (16.1%) | 5 |
| Vascular disorders | ||||||||
| Hypertension | 2/31 (6.5%) | 2 | 1/31 (3.2%) | 1 | 3/19 (15.8%) | 3 | 5/31 (16.1%) | 5 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. E. Clarke Haley, Jr. |
|---|---|
| Organization | University of Virginia Health System |
| Phone | 434-924-8041 |
| ech@virginia.edu |
- 11231
- R01NS045170
- R01NS037666