Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUDRA CT NO: 2013-001514-15 |
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The primary objective of the study is to determine whether one 300 mg dose of intravenous (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic resonance imaging (MRI) in participants with acute ischemic stroke when given at ≤6 hours or at >6 to ≤9 hours from when they were last known normal (LKN).
The secondary objectives of this study in this study population are as follows: to assess the efficacy of natalizumab on change in infarct volume from Baseline to Day 30; to assess efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30; to assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the safety of natalizumab in participants with acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| natalizumab | Experimental | 300 mg single intravenous (IV) injection |
|
| Placebo | Placebo Comparator | A single IV dose of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| natalizumab | Drug | Administered as described in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR]) | Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth. | Baseline, Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR) | Relative growth of infarct volume from Baseline (relative growth = FLAIR at 24 hours divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth. | Baseline, 24 hrs |
| Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Diego | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28229893 | Derived | Elkins J, Veltkamp R, Montaner J, Johnston SC, Singhal AB, Becker K, Lansberg MG, Tang W, Chang I, Muralidharan K, Gheuens S, Mehta L, Elkind MSV. Safety and efficacy of natalizumab in patients with acute ischaemic stroke (ACTION): a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Neurol. 2017 Mar;16(3):217-226. doi: 10.1016/S1474-4422(16)30357-X. Epub 2017 Feb 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | A single intravenous (IV) injection of placebo |
| FG001 | Natalizumab | 300 mg single IV injection of natalizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo | Drug | Matched placebo |
|
Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 30 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth. |
| Baseline, Day 30 |
| Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR) | Relative growth of infarct volume from 24 hours (relative growth = FLAIR at Day 5 divided by FLAIR at 24 hours). Geometric mean calculated as the exponential of the mean log relative growth. | 24 hours, Day 5 |
| Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR) | Relative growth in infarct volume from Baseline (relative growth = FLAIR Day 30 divided by FLAIR at 24 hours ). Geometric mean calculated as the exponential of the mean log relative growth. | 24 hours, Day 30 |
| Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR) | Relative growth of infarct volume from Day 5 (relative growth = FLAIR at Day 30 divided by FLAIR at Day 5). Geometric mean calculated as the exponential of the mean log relative growth. | Day 5, Day 30 |
| Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90 | The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Scores for the NIHSS range from 0 to 42, with 0 representing no symptoms and 42 representing death. | Baseline, 24 hours, Day 5, Day 30, Day 90 |
| Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90 | The mRS measures independence, rather than neurologic function, with specific tasks pre- and post-stroke, respectively. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. The distribution of mRS scores was summarized at each timepoint. An excellent outcome on the mRS was defined as a score of 0 or 1, while a good outcome was defined as a score of 0, 1, or 2. | Day 5, Day 30, and Day 90 |
| Barthel Index at Day 5, Day 30, and Day 90 | The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility, and can be used to determine a baseline level of functioning and to monitor change in activities of daily living over time. The scores for each of the items are summed to create a total score up to a potential of 100, with higher scores representing a greater level of independence. | Day 5, Day 30, and Day 90 |
| Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as severe, moderate, or mild, and related or not related to study treatment. | Up to Day 90 ± 5 days |
| Gainesville |
| Florida |
| United States |
| Research Site | Kansas City | Kansas | 66160 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Golden Valley | Minnesota | 55422 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Lake Success | New York | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | Durham | North Carolina | 27710 | United States |
| Research Site | Akron | Ohio | United States |
| Research Site | Dayton | Ohio | 45409 | United States |
| Research Site | Toledo | Ohio | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Tualatin | Oregon | 97062 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Charlottesville | Virginia | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| Research Site | Altenburg | 04600 | Germany |
| Research Site | Bad Neustadt an der Saale | 97616 | Germany |
| Research Site | Berlin | 12203 | Germany |
| Research Site | Bonn | Germany |
| Research Site | Düsseldorf | 40225 | Germany |
| Research Site | Erlangen | 91054 | Germany |
| Research Site | Frankfurt | 60528 | Germany |
| Research Site | Hanover | Germany |
| Research Site | Heidelberg | 69120 | Germany |
| Research Site | Idar-Oberstein | 55743 | Germany |
| Research Site | Leipzig | 04103 | Germany |
| Research Site | Ludwigshafen | 67063 | Germany |
| Research Site | Ludwigshafen | Germany |
| Research Site | Mannheim | Germany |
| Research Site | Trier | 54290 | Germany |
| Research Site | Tübingen | 72076 | Germany |
| Research Site | Ulm | Germany |
| Research Site | Albacete | 02006 | Spain |
| Research Site | Badalona | 8916 | Spain |
| Research Site | Barakaldo | Spain |
| Research Site | Barcelona | 8003 | Spain |
| Research Site | Barcelona | 8035 | Spain |
| Research Site | Barcelona | 8036 | Spain |
| Research Site | Girona | 17007 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Pamplona | 31008 | Spain |
| Research Site | Santiago de Compostela | 15706 | Spain |
| Research Site | Seville | 41009 | Spain |
| Research Site | Seville | 41013 | Spain |
| Research Site | Valencia | Spain |
| Research Site | Valladolid | 47005 | Spain |
| Withdrew Prior to Dosing |
|
| Dosed |
|
| Received Total Volume of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | A single IV injection of placebo |
| BG001 | Natalizumab | 300 mg single IV injection of natalizumab |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR]) | Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth. | Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points. | Posted | Geometric Mean | Inter-Quartile Range | mL | Baseline, Day 5 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR) | Relative growth of infarct volume from Baseline (relative growth = FLAIR at 24 hours divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth. | Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points. | Posted | Geometric Mean | Inter-Quartile Range | mL | Baseline, 24 hrs |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR) | Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 30 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth. | Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points. | Posted | Geometric Mean | Inter-Quartile Range | mL | Baseline, Day 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR) | Relative growth of infarct volume from 24 hours (relative growth = FLAIR at Day 5 divided by FLAIR at 24 hours). Geometric mean calculated as the exponential of the mean log relative growth. | Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points. | Posted | Geometric Mean | Inter-Quartile Range | mL | 24 hours, Day 5 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR) | Relative growth in infarct volume from Baseline (relative growth = FLAIR Day 30 divided by FLAIR at 24 hours ). Geometric mean calculated as the exponential of the mean log relative growth. | Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points. | Posted | Geometric Mean | Inter-Quartile Range | mL | 24 hours, Day 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR) | Relative growth of infarct volume from Day 5 (relative growth = FLAIR at Day 30 divided by FLAIR at Day 5). Geometric mean calculated as the exponential of the mean log relative growth. | Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points. | Posted | Geometric Mean | Inter-Quartile Range | mL | Day 5, Day 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90 | The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Scores for the NIHSS range from 0 to 42, with 0 representing no symptoms and 42 representing death. | Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessments at Baseline and given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 24 hours, Day 5, Day 30, Day 90 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90 | The mRS measures independence, rather than neurologic function, with specific tasks pre- and post-stroke, respectively. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. The distribution of mRS scores was summarized at each timepoint. An excellent outcome on the mRS was defined as a score of 0 or 1, while a good outcome was defined as a score of 0, 1, or 2. | Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment), using imputed data; n=number of participants with an assessment at given time point. | Posted | Number | participants | Day 5, Day 30, and Day 90 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Barthel Index at Day 5, Day 30, and Day 90 | The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility, and can be used to determine a baseline level of functioning and to monitor change in activities of daily living over time. The scores for each of the items are summed to create a total score up to a potential of 100, with higher scores representing a greater level of independence. | Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessment at given time point. | Posted | Median | Full Range | units on a scale | Day 5, Day 30, and Day 90 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as severe, moderate, or mild, and related or not related to study treatment. | Safety population (all participants who were randomized and received any portion of the infusion of study treatment). | Posted | Number | participants | Up to Day 90 ± 5 days |
|
|
From informed consent (SAE) or initiation of study drug (AE) until Final Visit Day 90 ± 5 days or early termination follow-up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | A single IV injection of placebo | 38 | 82 | 75 | 82 | ||
| EG001 | Natalizumab | 300 mg single IV injection of natalizumab | 36 | 78 | 68 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Splenic haemorrhage | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Toxic nodular goitre | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Avulsion fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Basilar artery thrombosis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Brain midline shift | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dementia alzheimer's type | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Generalised non-convulsive epilepsy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stroke in evolution | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Subdural hygroma | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Endarterectomy | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Post stroke depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | clinicaltrials@biogen.com |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| 40 to 59 years |
|
| 60 to 79 years |
|
| >/= 80 years |
|
| Male |
|
| repeated measures mixed effects model |
| 0.779 |
one-sided p-value |
| ratio of relative growth |
| 1.09 |
| 2-Sided |
| 90 |
| 0.91 |
| 1.30 |
Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio. |
| No |
| Superiority or Other |
|
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|
|
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| Counts |
|---|
| Participants |
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