drugset / Trial / NCT05142228

Erenumab-aooe for the Management of Trigeminal Neuropathic Pain.

NCT05142228

Phase 2 Terminated 5 enrolled University of Maryland, Baltimore Amgen · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This study is a single center, placebo-controlled, double blind, randomized, phase II pilot to evaluate the efficacy of erenumab-aooe in the management of trigeminal neuropathic pain comparing erenumab-aooe vs Placebo. A total of 40 patients (20 each arm) aged 18-65 years old of either sex, and any race or ethnicity, presenting trigeminal neuropathic pain will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either Erenumab or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks. Changes in pain intensity and other pain related outcomes of trigeminal neuropathic pain will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.

Timeline

Start
2022-05-31
Primary completion
2022-10-27
Completion
2022-10-27

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Erenumab Monoclonal antibody 140 mg Subcutaneous