MedTrace Logo

Erenumab-aooe for the Management of Trigeminal Neuropathic Pain.

NCT05142228 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-03-22

Study results available
· View outcomes & findings →

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.

Conditions

  • Trigeminal Neuropathy

Interventions

DRUG

Erenumab-Aooe

Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.

OTHER

Placebo

Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2022-10-27
Completion
2022-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05142228 on ClinicalTrials.gov