Noosphere
Research Projects
Open, version-controlled scientific research. Join, fork, validate, fund. Each project is a landmark clinical trial reformatted as a collaborative surface — primary endpoints, enrollment status, and the historical / current / future claims bound to it.
CLARITY-AD (lecanemab) · 2023 · New England Journal of Medicine
Lecanemab in Early Alzheimer’s Disease
Lecanemab slows cognitive decline in early Alzheimer disease with amyloid confirmation, with a non-trivial ARIA safety signal.
Primary endpoint
Core Study: Change from Baseline in the CDR-SB at 18 Months
$2.0M / $3.5M
56%
12 collaborators
MEMBRANE
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Middle meningeal artery embolization reduces recurrence of chronic subdural hematoma.
Primary endpoint
Residual or Re-accumulation of the Chronic Subdural Hematoma (cSDH) (Greater Than [>] 10 Millimeter [mm]) as Assessed by an Independent Core Laboratory OR Any Re-operation or Surgical Procedure on the cSDH at 6 Months
$4.2M / $4.9M
86%
13 collaborators
EMBOLISE
A Study of the Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE)
MMA embolization as an adjunct to surgical evacuation lowers recurrence for symptomatic chronic subdural hematoma.
Primary endpoint
Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline
$1.0M / $3.8M
27%
16 collaborators
PUFS
FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens
Pipeline flow-diverter achieves durable occlusion of large and giant internal carotid aneurysms.
Primary endpoint
Overall survival
$1.4M / $2.0M
68%
26 collaborators
KEYNOTE-522 · 2020 · New England Journal of Medicine
Pembrolizumab for Early Triple-Negative Breast Cancer
Neoadjuvant pembrolizumab + chemotherapy increases pathologic complete response rate in triple-negative breast cancer.
Primary endpoint
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
$1.3M / $3.9M
32%
7 collaborators
ISCHEMIA · 2020 · New England Journal of Medicine
Initial Invasive or Conservative Strategy for Stable Coronary Disease
In stable CAD with moderate-to-severe ischemia, an initial invasive strategy does not reduce cardiovascular events vs.
Primary endpoint
Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest
$1.1M / $3.5M
31%
30 collaborators
EMPEROR-Reduced · 2020 · New England Journal of Medicine
Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure
Empagliflozin reduces cardiovascular death or heart-failure hospitalization in HFrEF regardless of diabetes status.
Primary endpoint
Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
$1.5M / $3.0M
48%
27 collaborators
EMERGE (aducanumab)
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease
Aducanumab’s pivotal phase 3 showed mixed evidence for cognitive slowing in early Alzheimer disease.
Primary endpoint
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78
$967K / $3.4M
28%
13 collaborators
NURTURE (nusinersen)
An Open-Label Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ISIS 396443 Delivered Intrathecally to Subjects With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy
Presymptomatic nusinersen in SMA infants preserves motor function milestones in long-term follow-up.
Primary endpoint
Time to Death or Respiratory Intervention
$1.4M / $2.7M
51%
8 collaborators
ADVANCE (atogepant)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine (ADVANCE)
Atogepant, an oral CGRP receptor antagonist, reduces monthly migraine days in episodic migraine preventive therapy.
Primary endpoint
Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period
$2.9M / $3.8M
78%
9 collaborators
CLIMB-121 (exa-cel, sickle cell)
A Phase 1/2/3 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (CTX001) in Subjects With Severe Sickle Cell Disease
CRISPR-Cas9 BCL11A editing (exa-cel) eliminates vaso-occlusive crises in severe sickle cell disease over multi-year follow-up.
Primary endpoint
Proportion of subjects who have not experienced any severe vaso-occlusive crisis (VOC) for at least 12 consecutive months (VF12)
$174K / $1.2M
15%
25 collaborators
HGB-206 (lovo-cel)
A Phase 1/2 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With the LentiGlobin BB305 Lentiviral Vector in Subjects With Severe Sickle Cell Disease
Lentiviral β-globin gene therapy reduces or eliminates VOC events in severe sickle cell disease.
Primary endpoint
Percentage of Group C Participants Who Achieved Complete Resolution of Vaso-occlusive Events (VOE-CR)
$645K / $2.9M
22%
17 collaborators
STR1VE (onasemnogene abeparvovec / Zolgensma)
Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies Delivering AVXS-101 by Intravenous Infusion
Single-dose IV AAV9-SMN1 gene therapy produces durable motor benefit in SMA type 1 infants.
Primary endpoint
Achievement of Independent Sitting for at Least 30 Seconds
$1.2M / $4.0M
31%
20 collaborators
HOPE-B (Hemgenix / etranacogene)
Phase III, Open-label, Single-dose, Multi-center, Multinational Trial Investigating a Serotype 5 Adeno-associated Viral Vector Containing the Padua Variant of a Codon-optimized Human Factor IX Gene (AAV5-hFIXco-Padua, AMT-061) Administered to Adult Subjects With Severe or Moderately Severe Hemophilia B
AAV5 FIX-Padua gene therapy produces sustained Factor IX activity, reducing bleeds in severe hemophilia B.
Primary endpoint
Annualized Bleeding Rate (ABR) for All Bleeding Episodes
$2.6M / $3.1M
85%
26 collaborators
DAPA-HF · 2019 · New England Journal of Medicine
Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction
Dapagliflozin reduces heart-failure worsening and CV death in HFrEF with or without diabetes.
Primary endpoint
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
$731K / $2.8M
26%
19 collaborators
DAWN · 2018 · New England Journal of Medicine
Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct
Mechanical thrombectomy benefits selected large-vessel-occlusion stroke patients in the 6–24h window.
Primary endpoint
Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome
$846K / $4.7M
18%
12 collaborators
DEFUSE-3 · 2018 · New England Journal of Medicine
Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging
Imaging-selected patients benefit from thrombectomy 6–16h after last-known-well.
Primary endpoint
The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90
$2.0M / $2.7M
77%
17 collaborators
KEYNOTE-189 · 2018 · New England Journal of Medicine
Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer
Pembrolizumab plus chemotherapy improves overall survival in metastatic non-squamous NSCLC without targetable mutations.
Primary endpoint
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging
$916K / $3.0M
31%
14 collaborators
ORBITA · 2018 · The Lancet
Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial
PCI does not improve exercise time vs.
Primary endpoint
Exercise Time on Treadmill
$1.7M / $2.4M
73%
7 collaborators
CheckMate-067 · 2017 · New England Journal of Medicine
Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma
Nivolumab + ipilimumab combination yields superior long-term survival in advanced melanoma vs.
Primary endpoint
Progression Free Survival (PFS)
$1.6M / $2.7M
58%
17 collaborators
LUXTURNA (voretigene) · 2017 · The Lancet
Efficacy and safety of voretigene neparvovec (AAV2-hRPE65v2) in patients with RPE65 -mediated inherited retinal dystrophy: a randomised, controlled, open-label, phase 3 trial
Subretinal AAV2-hRPE65 gene therapy improves functional vision in biallelic RPE65-associated inherited retinal dystrophy.
Primary endpoint
Multi-luminance Mobility Testing (MLMT), Bilateral
$1.1M / $4.0M
27%
5 collaborators
MONALEESA-2 · 2016 · New England Journal of Medicine
Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer
Adding ribociclib to letrozole improves progression-free survival in HR+/HER2− advanced breast cancer.
Primary endpoint
Progression Free Survival (PFS) by Investigator Assessment
$2.5M / $4.1M
62%
13 collaborators
MR CLEAN · 2015 · New England Journal of Medicine
A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke
Endovascular thrombectomy within 6h improves functional outcome in proximal anterior circulation stroke.
Primary endpoint
—
$610K / $2.5M
24%
21 collaborators
REVASCAT · 2015 · New England Journal of Medicine
Thrombectomy within 8 Hours after Symptom Onset in Ischemic Stroke
Thrombectomy up to 8h after stroke onset is superior to medical therapy in selected patients.
Primary endpoint
Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis)
$2.5M / $3.5M
72%
4 collaborators
EXTEND-IA · 2015 · New England Journal of Medicine
Endovascular Therapy for Ischemic Stroke with Perfusion-Imaging Selection
CT-perfusion-selected thrombectomy produces early neurological improvement vs.
Primary endpoint
Reperfusion at 24 hours (CT or MR perfusion imaging)
$708K / $3.2M
22%
25 collaborators
ESCAPE · 2015 · New England Journal of Medicine
Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke
Rapid endovascular treatment improves functional outcomes in proximal anterior-circulation stroke.
Primary endpoint
Shift in the mRS score, defined by a proportional odds model.
$404K / $3.5M
12%
4 collaborators
SWIFT PRIME · 2015 · New England Journal of Medicine
Stent-Retriever Thrombectomy after Intravenous t-PA vs. t-PA Alone in Stroke
Stent-retriever thrombectomy plus tPA is superior to tPA alone for proximal anterior-circulation stroke.
Primary endpoint
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
$1.8M / $3.2M
57%
15 collaborators
PARADIGM-HF · 2014 · New England Journal of Medicine
Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure
Sacubitril/valsartan (ARNI) reduces CV death and HF hospitalization vs.
Primary endpoint
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
$2.3M / $3.6M
65%
12 collaborators
EARLYSTIM · 2013 · New England Journal of Medicine
Neurostimulation for Parkinson's Disease with Early Motor Complications
Early STN-DBS improves quality of life in Parkinson disease patients with early motor complications vs.
Primary endpoint
PDQ-39
$2.1M / $2.4M
87%
11 collaborators
EMILIA · 2012 · New England Journal of Medicine
Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer
T-DM1 improves progression-free and overall survival vs.
Primary endpoint
Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)
$1.7M / $4.5M
37%
20 collaborators