NCT04249427

Erenumab for Idiosyncratic Facial Pain

A Randomized, Double-Blinded, Single Site Study to Evaluate the Efficacy of Erenumab for Treatment of Idiosyncratic Facial Pain Mimicking Rhinosinusitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: David Jang, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase IV randomized, double-blinded, placebo-controlled study to evaluate the efficacy of Erenumab in subjects with midfacial pain or pressure, without clinical or radiographic evidence of sinusitis.

Detailed description

Eligible participants are randomized to receive either Erenumab or placebo by subcutaneous injection once monthly for 6 months. Study duration is eight months which includes a 30 day screening/lead-in period and 6 monthly treatment visits followed by a follow-up visit one month following the last dose of study drug administration. Participants will be expected to score on a scale of 1 to 10 their symptoms of facial pain/pressure, nasal congestion, and rhinorrhea as well well as any rescue medicines taken for pain each day via a mobile app.

Conditions

• Facial Pain
• Rhinosinusitis

Interventions

Type	Name	Description
DRUG	Erenumab Prefilled Syringe	140mg Erenumab, pre-filled syringe given by subcutaneous injection
OTHER	Placebo	Placebo, pre-filled syringe given by subcutaneous injection

Timeline

• Start date: 2021-02-10
• Primary completion: 2023-07-11
• Completion: 2023-07-11
• First posted: 2020-01-31
• Last updated: 2024-09-24
• Results posted: 2024-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study