Trial reportNeurology2014
Fulranumab for treatment of diabetic peripheral neuropathic pain: A randomized controlled trial.
Trial report in Neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Standardized efficacy and safety evaluation of fulranumab for osteoarthritis.Clinical rheumatology · 2025Pooled it
- Different Drugs for the Treatment of Painful Diabetic Peripheral Neuropathy: A Meta-Analysis.Frontiers in neurology · 2021Pooled it
- Fulranumab in Patients With Pain Associated With Postherpetic Neuralgia and Postraumatic Neuropathy: Efficacy, Safety, and Tolerability Results From a Randomized, Double-blind, Placebo-controlled, Phase-2 Study.The Clinical journal of pain · 2017Trial
- Fulranumab in patients with interstitial cystitis/bladder pain syndrome: observations from a randomized, double-blind, placebo-controlled study.BMC urology · 2017Trial
- SCN9A Variants May be Implicated in Neuropathic Pain Associated With Diabetic Peripheral Neuropathy and Pain Severity.The Clinical journal of pain · 2015Trial
- TrkA abundance is increased in cutaneous nerves in bortezomib-induced neuropathy.Brain pathology (Zurich, Switzerland) · 2026Article
- Nerve Growth Factor in Diabetes Mellitus: Pathophysiological Mechanisms, Biomarkers and Therapeutic Opportunities.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Diabetic neuropathy: cutting-edge research and future directions.Signal transduction and targeted therapy · 2025Review
- NGF in Neuropathic Pain: Understanding Its Role and Therapeutic Opportunities.Current issues in molecular biology · 2025Review
- Diabetic Peripheral Neuropathy: Pathophysiology and New Insights into the Mechanism of Action of High-Concentration Topical Capsaicin.Journal of experimental pharmacology · 2025Review
- Targeting Perineural Invasion in Pancreatic Cancer.Cancers · 2024Review
- Systemic and Peripheral Mechanisms of Cortical Stimulation-Induced Analgesia and Refractoriness in a Rat Model of Neuropathic Pain.International journal of molecular sciences · 2023Article
- Monoclonal Antibody Therapy for the Treatment of Interstitial Cystitis.Biologics : targets & therapy · 2022Review
- Challenges of neuropathic pain: focus on diabetic neuropathy.Journal of neural transmission (Vienna, Austria : 1996) · 2020Review
- Nerve Growth Factor Antagonists: Is the Future of Monoclonal Antibodies Becoming Clearer?Drugs · 2017Review
- Anti-nerve growth factor in pain management: current evidence.Journal of pain research · 2016Review
- Scientometrics of drug discovery efforts: pain-related molecular targets.Drug design, development and therapy · 2015Article
- Monoclonal antibodies for chronic pain: a practical review of mechanisms and clinical applications.Molecular painReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess efficacy and safety of fulranumab, a fully human monoclonal antibody against nerve growth factor, in patients with diabetic peripheral neuropathic pain (DPNP).
methodsIn this phase II, double-blind, placebo-controlled trial, patients with moderate to severe DPNP were randomized to treatments with fulranumab (1, 3, or 10 mg) or placebo administered subcutaneously every 4 weeks.
resultsBecause of early study termination (clinical hold) by the US Food and Drug Administration, 77 (intent-to-treat) of the planned 200 patients were enrolled. The primary endpoint, the mean reduction of average daily pain at week 12 compared with baseline, showed a positive dose-response relationship (p = 0.014, 1-sided); the pair-wise comparison between the 10-mg group and placebo was significant (unadjusted p = 0.040, 2-sided). An exploratory responder analysis revealed that a greater proportion of patients in the 10-mg group reported ≥30% reduction in the average DPNP intensity compared with placebo at week 12 (p = 0.006). Although not statistically significant, several secondary endpoints showed directionally similar results to the primary efficacy dose-response relationship. During the combined efficacy and safety extension phases, the top 3 treatment-emergent adverse events in the combined fulranumab group were arthralgia (11%), edema peripheral (11%), and diarrhea (9%). No cases of joint replacement or death were reported.
conclusionDespite early study termination, fulranumab treatment resulted in dose-dependent efficacy and was generally well tolerated. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that in patients with DPNP, fulranumab 10 mg reduces pain by 1.2 points on an 11-point scale compared with placebo.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.