Erbitux against neuropathic pai

Conditions: europathic pain conditions, i.e. radiculopathy or Complex regional pain syndrome
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2015-001195-21-NO

Lead Sponsor: Sørlandet Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

All of the following conditions must apply for inclusion:

•Signed informed consent and anticipated compliance with the treatment and study follow-up according to ICH GCP, and national/local regulations.
•Pain defined as definite” neuropathic pain, according to the Special Interest Group on Neuropathic Pain (NeuPSIG) guidelines or defined as probable” NP, according to the NeuPSIG guidelines, if the confirmatory test (see figure 2) was a positive diagnostic test, i.e. positive finding on radiologic or neurophysiological testing. Complex regional pain syndrome (CRPS) can be included despite lack of an offending lesion, as long as the Budapest criteria”1 are fulfilled:
Clinical diagnostic criteria for complex regional pain syndrome
1) Continuing pain, which is disproportionate to any inciting event
2) Must report at least one symptom in three of the four following categories:
Sensory: Reports of hyperalgesia and/or allodynia
Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry
Sudomotor/Edema: Reports of edema and/or sweating changes and/or sweating asymmetry
Motor/Trophic: Reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
3) Must display at least one sign at time of evaluation in two or more of the following categories
Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure and/or joint movement)
Vasomotor: Evidence of temperature asymmetry and/or skin color changes and/or asymmetry
Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating asymmetry
Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
4) There is no other diagnosis that better explains the signs and symptoms.

•Neuropathic Pain associated with compressive nerve states (including failed surgery) or CRPS (according to the Budapest criteria”1
•Pain Detect score of at least 13 with average pain intensity of at least 6 /10 over the last four weeks. In addition, a pain DETECT pattern indicating that the underlying NP is constantly present.
•Worst pain intensity higher than 6 for five of seven days during the screening phase, according to BPI-sf as assessed by the referring physician.
•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.
•NP 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 (WOCBP) and men must use an acceptable method of contraception# throughout the study, and for 30 days after the last study drug administration.
•WOCBP must have a negative pregnancy blood (hCG) test within 7 days before each treatment period.
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Exclusion Criteria

Patients will be excluded from the study if they meet any of the following 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 scheme.
•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.