ArticleExperimental & translational stroke medicine2014
Analysis of early phase and subsequent phase III stroke studies of neuroprotectants: outcomes and predictors for success.
Article in Experimental & translational stroke medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Potential of Biomaterial-Based Approaches as Therapies for Ischemic Stroke: A Systematic Review and Meta-Analysis of Pre-clinical Studies.Frontiers in neurology · 2019Pooled it
- How to Pick a Neuroprotective Drug in Stroke Without Losing Your Mind?Life (Basel, Switzerland) · 2025Review
- A Contextual-Bandit-Based Approach for Informed Decision-Making in Clinical Trials.Life (Basel, Switzerland) · 2022Article
- Sovateltide Mediated Endothelin B Receptors Agonism and Curbing Neurological Disorders.International journal of molecular sciences · 2022Review
- Lesion Size- and Location-Dependent Recruitment of Contralesional Thalamus and Motor Cortex Facilitates Recovery after Stroke in Mice.Translational stroke research · 2021Article
- Exploring the Potential Mechanism of Shennao Fuyuan Tang for Ischemic Stroke Based on Network Pharmacology and Molecular Docking.Evidence-based complementary and alternative medicine : eCAM · 2021Article
- Sovateltide (IRL-1620) activates neuronal differentiation and prevents mitochondrial dysfunction in adult mammalian brains following stroke.Scientific reports · 2020Article
- Materials to Promote Recovery After Stroke.Current opinion in biomedical engineering · 2020Article
- Soluble Nogo receptor 1 fusion protein protects neural progenitor cells in rats with ischemic stroke.Neural regeneration research · 2019Article
- Multi-arm multi-stage trials can improve the efficiency of finding effective treatments for stroke: a case study.BMC cardiovascular disorders · 2018Article
- Neuroprotective Effect and Mechanism of Action of Tetramethylpyrazine Nitrone for Ischemic Stroke Therapy.Neuromolecular medicine · 2018Article
- Tetramethylpyrazine nitrone activates the BDNF/Akt/CREB pathway to promote post-ischaemic neuroregeneration and recovery of neurological functions in rats.British journal of pharmacology · 2018Article
- Embracing Biological and Methodological Variance in a New Approach to Pre-Clinical Stroke Testing.Translational stroke research · 2016Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEfficacy of neuroprotective treatments for ischemic stroke was not convincingly demonstrated in clinical phase III trials so far, whereas some preceding early phase studies found neuroprotection to be beneficial. We aimed to determine the frequency with which phase III studies are preceded by positive early phase studies, and to identify characteristics of early phase studies that are associated with correct prediction of phase III studies.
methodsWe identified phase III studies and corresponding early phase studies of neuroprotective treatments for stroke. Data on study characteristics of early phase trials were extracted and compared between studies that were classified according to their results as "false positive" and "true neutral" using logistic regression analysis.
resultsForty-six phase III studies and 59 corresponding early phase studies were identified. Only one phase III study was positive and this study was followed by a larger negative study. Twenty-two (37.3%) early phase studies were considered to be false positive and 37 (62.7%) to be true neutral. None of the early phase study characteristics were significantly associated with correct prediction of phase III studies.
conclusionsMore than one third of early phase studies on neuroprotective stroke treatments are false positive. Neither the results nor specific study design characteristics of early phase stroke studies reliably predict success in phase III trials. Further efforts are needed to improve early phase studies regarding its predictability and to identify those early studies that should be advanced to phase III trials.
Identifiers
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Registered trials
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