NoTOPain

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2015
INTERVENTION: Trade Name: Erbitux Product Name: Erbitux Pharmaceutical Form: Solvent for solution for infusion Pharmaceutical form of the placebo: Solvent for solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Neuropathic pain conditions, i.e. radiculopathy or Complex regional pain syndrome Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: The primary objective is to determine whether a single infusion of cetuximab compared to placebo is effective in significantly reducing average daily neuropathic pain score measured over 5 days in patients with defined neuropathic pain. Primary end point(s): Mean difference in average daily pain scores Secondary Objective: • To determine the number of patients who achieve 30% and 50% reductions (following cetuximab vs. placebo) of average daily neuropathic pain scores, measured over 5 days, compared to baseline. ; • To determine the difference in the average worst daily neuropathic pain score (following cetuximab vs. placebo), measured over 5 days, compared to baseline. ; • To determine the number of patients who achieve 30% and 50% reductions (following cetuximab vs. placebo) of average daily worst neuropathic pain scores, measured over 5 days, compared to baselinepatients. ; • Comparison of patient satisfaction with cetuximab and placebo for NP seven days after each infusion, using the Patient Global Impression of Change (PGICS) as the endpoint measure.; • Comparison of overall mean reduction in BPI interference scores and total BPI scores (following cetuximab vs. placebo), compared to baseline. ; • To document safety and toxicity of cetuximab compared with placebo in patients with NP. ; Timepoint(s) of evaluation of this end point: 4‐8 days after infusion SECONDARY OUTCOME: Secondary end point(s): Number of patients who achieve 30% and 50% reductions (following cetuximab vs. placebo) of average daily neuropathic pain scores. Timepoint(s) of evaluation of this end point: 4‐8 days after infusion 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 Va
Epistemonikos ID: 274d08a1cdb1200285801bef0e033f746fa5d691
First added on: Aug 23, 2024