Trial intelligence / Profile preview

Cetuximab in neuropathic pain

NCT02490436Phase 2

Key facts

Status: Completed
Start: Oct 2015
Primary completion: Oct 2016
Countries: 1
Sponsor: Sørlandet sykehus
Modality: Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies

Drugs: cetuximab
Conditions: neuropathic pain

Overview

Phase 2, randomised, double-blind trial of cetuximab in neuropathic pain (2 arms), sponsored by Sørlandet sykehus. Primary endpoint: Change in average neuropathic pain score. Started Oct 2015; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Active First
Cetuximab -> Placebo -> Open-label Cetuximab
Placebo First
Placebo -> Cetuximab -> Open-label Cetuximab

Who it enrols

Patients with definite or probable chronic neuropathic pain (including CRPS) refractory to standard treatments, with a painDETECT score >= 13 and average pain >= 6/10.

Endpoints

Primary

Change in average neuropathic pain scoreDays 4-8 post-infusion

Secondary

Frequency of at least 30% reduction in average neuropathic pain scoreDays 4-8 post-infusion
Frequency of at least 50% reduction in average neuropathic pain scoreDays 4-8 post-infusion
Change in average worst neuropathic pain scoreDays 4-8 post-infusion
Patient Global Impression of ChangeDay 7 post-infusion
Brief Pain Inventory interference scoresDays 4-8 post-infusion
Number of AE and SAE recordingUp to 30 days post-last infusion

Results

Not all primary endpoints met

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