novel treatment option for neuropathic pain

Conditions: Neuralgia; Complex Regional Pain Syndromes

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


Eligibility criteria:
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 primarily experiencing pain 'attacks', i.e. pattern of neuropathic pain depicted in picture 3 of the paindetect. * other pain state that may interfere with evaluation of the studied neuropathic pain condition. * any underlying medical or psychiatric condition, clinical disorder or laboratory finding, which in the opinion of the investigator may interfere with study objectives. * uncontrolled or unstable diabetes. * severe or uncontrolled cardiovascular disease (congestive heart failure nyha iii or iv), unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias * severe cerebrovascular disease during the six months prior to inclusion. * active and ongoing eye and skin disorders or newly diagnosed gastric ulcer that may interfere with the study treatment. * history of allergic reaction to any of the study treatment components, red meat or tick bites. * previous treatment with any egfr-pathway inhibitor. * women who are pregnant or breastfeeding. * participation in another clinical trial within the past 90 days. * use of any investigational agent within 90 days prior to day 1 of study drug. * known drug abuse/alcohol abuse, legal incapacity or limited legal capacity or any other reason that, in the opinion of the investigator precludes the subject from participating.