RCTNCT01933529Phase 2 · 2013 · n=24 · Claes-Göran Östenson Diabetes Type 2
tested oral glucose tolerance
result In progress (unknown)
RCTNCT02039687Phase 2 · 2014 · n=64 · Araim Pharmaceuticals, Inc. Neuropathy of Sarcoidosis
tested Change in Corneal Nerve Fiber Area
result +106 µm^2 (Change in Corneal Nerve Fiber Area)
RCTNCT02070783Phase 1 · 2012 · n=36 · Leiden University Medical Center Depression
tested performance on information processing test battery, particularly emotion recognition
result Completed; results not posted
Treatment studies
tested SFNSL score, BPI pain intensity, SF-36, depressive symptoms (IDS), fatigue (FAS)
result SFNSL Δ -11.5±3.04 (ARA 290) vs Δ -2.9±3.34 (placebo), p<0.05; SF-36 pain Δ -23.4±5.5, physical functioning Δ -14.6±3.9 significant; BPI+FAS improved equally in both groups; no IDS change.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested neuropathic symptoms (patient-reported), corneal nerve fiber density, cutaneous temperature sensitivity, 6-minute walk test
result 28d daily SC ARA 290 significantly improved neuropathic symptoms, increased corneal small nerve fiber density, improved temperature sensitivity and 6-min walk distance vs placebo.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested HbA1c, lipid profiles, PainDetect score, corneal nerve fiber density (CNFD)
result ARA 290 improved HbA1c and lipid profiles over 56d; PainDetect scores improved significantly; subjects with low CNFD showed significant increase vs no change in placebo.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Corneal nerve fiber area (CNFA), GAP-43+ intraepidermal fibers, pain severity, 6-minute walk test
result 4 mg/day: placebo-corrected CNFA +697 μm² (P=0.012); GAP-43+ fibers increased (P=0.035); CNFA correlated with 6MWT (ρ=0.645, P=0.009); pain improved across all groups.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
OpenNCT06626971Phase 2 · 2016 · n=9 · Belfast Health and Social Care Trust Diabetic Macular Oedema
tested Primary Outcome - Best corrected distance visual acuity.
result Terminated before completion
Terminated: Expiry of study drug - no replacement available.
Treatment studies
tested neuropathic pain scores, corneal nerve fiber density, sensory pain thresholds, quality of life, physical functioning
result Two Phase II trials: ARA 290 significantly reduced neuropathic pain scores, increased corneal nerve fibers, improved sensory pain thresholds, QoL, and physical functioning in sarcoidosis patients.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested utility of corneal nerve fiber (CNF) size (width, area) vs standard CCM variables (density, branch density, length) for diagnosing SFN and quantifying therapeutic response to cibinetide
result CNF area, density, branch density and length show comparable discriminatory power for diagnosing neuropathy; CNF area is a useful variable for quantifying change in CNF morphology following cibinetide (nerve repair).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested BCVA, CRT, central retinal sensitivity, tear production, NEI VFQ-25, adverse events, anti-cibinetide antibodies
result No mean improvement in BCVA (-2.9), CRT (+10 µm), retinal sensitivity (-0.53 dB), or tear production; NEI VFQ-25 improved (+2.7). Some participants improved in CRT, tear production, HbA1c, albuminuria.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Preclinical / mechanistic research
tested mouse · Ketamine does not produce relief of neuropathic pain in mice lacking the β-common receptor (CD131).
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · A non-erythropoietic peptide derivative of erythropoietin decreases susceptibility to diet-induced insulin resistance in mice.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · Erythropoietin-Derived Peptide Protects Against Acute Lung Injury After Rat Traumatic Brain Injury.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Activation of the EPOR-β common receptor complex by cibinetide ameliorates impaired wound healing in mice with genetic diabetes.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · Erythropoietin Mimetic Peptide (pHBSP) Corrects Endothelial Dysfunction in a Rat Model of Preeclampsia.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · Assessment of the Nephroprotective Properties of the Erythropoietin Mimetic Peptide and Infliximab in Kidney Ischemia-Reperfusion Injury in Rats.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Targeting the innate repair receptor axis <i>via</i> erythropoietin or pyroglutamate helix B surface peptide attenuates hemolytic-uremic syndrome in mice.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Immunometabolic dysregulation drives selective executive cognitive dysfunction in male db/db mice.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested The erythropoietin-derived peptide mimetic pHBSP affects cellular and cognitive consequences in a rat post-status epilepticus model.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested Characterization of in vitro generated metabolites of selected peptides <2 kDa prohibited in sports.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested The Non-Erythropoietic EPO Analogue Cibinetide Inhibits Osteoclastogenesis In Vitro and Increases Bone Mineral Density in Mice.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.