Clinical trial NCT02490436 (phase 2, status: completed)
Conditions: neuralgia, complex regional pain syndromes
ICD codes: G50.0, M54.81, B02.22, M79.2, G90.50, G90.511, G90.512, G90.513, G90.519, G90.521, G90.522
Drugs: cetuximab, placebo
SMILES: [H][C@]12SCC(COC(C)=O)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\C1=CSC(N)=N1)C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.