Novel Treatment Option for Neuropathic Pain

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sorlandet Hospital HF
• Collaborators: Frontier Science & Technology Research Foundation, Inc.; Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Cetuximab

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.