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Novel Treatment Option for Neuropathic Pain

CompletedPhase 2NCT02490436
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than placebo for the treatment of neuropathic pain.

Study details

Official title
A Randomized, Cross-over, Placebo-controlled, Double-blind, Single-center, Phase II Study of Cetuximab in Patients With Treatment-refractory, Non-malignant Severe Chronic Neuropathic Pain
Interventions
Sponsor
Sorlandet Hospital HF
Collaborators
Frontier Science & Technology Research Foundation, Inc.; Merck KGaA, Darmstadt, Germany
Start date
2015-10
Primary completion
2016-10
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Norway
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Signed informed consent and anticipated compliance. * Pain defined as "definite" neuropathic pain, according to the Special Interest Group on Neuropathic Pain guidelines or defined as "probable" NP, according to the guidelines, if the confirmatory test was a positive diagnostic test. Complex regional pain syndrome can be included despite lack of an offending lesion, as long as the "Budapest criteria" are fulfilled * Neuropathic Pain associated with compressive nerve states (including failed surgery) or CRPS (according to the "Budapest criteria") * PainDETECT score of at least 13 with average pain intensity of at least 6 /10 over the last four weeks. In addition, a painDETECT pattern indicating that the underlying neuropathic pain is constantly present. * Worst pain intensity higher than 6 for five of seven days during the screening phase, according to Brif Pain Inventory. * The patient should be able to distinguish between the neuropathic pain and other pain conditions, including elements of nociceptive pain caused by the same disease process. * Neuropathic pain duration of between six and thirty months, deemed chronic and likely to be irreversible by clinical history and findings. * No new or increased neuropathic pain treatment for the last four weeks. * Standard medical treatments for the patients' underlying condition or neuropathic pain must have been considered or tried and must, according to the opinion of the referring or a consulted pain specialist, be judged to be inappropriate or of insufficient potential efficacy. * Referring physician agreement to follow up the patient after study completion according to the best possible and available pain treatment and care. * Women of childbearing potential and men must use an acceptable method of contraception throughout the study, and for 30 days after the last study drug administration. * Negative pregnancy test within 7 days before each treatment period where appropriate. * White blood cell count ≥ 3 × 109 with neutrophils ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin ≥ 6.21 mmol/L (10 g/dL). Total bilirubin ≤ 1.5 × upper limit of reference range and AST and ALT ≤ 2.5 × upper limit of reference range within the last 28 days before inclusion. * Aged 18 or above Exclusion Criteria: * Neuropathic pain origin in the central nervous system. * Phantom limb pain or a significant component of nociceptive pain. * Ascending distal small fiber peripheral neuropathy. * Patients pr…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02490436