Treatment of Atypical Resistant Facial Pain

NCT07250984 | Enrolling By Invitation DMC

• 1 other identifier: 0120-331/2024-2711-8
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Facial pain in the trigeminal nerve region, which is not a migraine headache is often very persistent and difficult to treat. Research findings suggest that, similar to the mechanisms of migraine headache, the increased concentration of calcitonin gene-related peptide (CGRP) plays an important role in the mechanisms of facial pain. Therefore, the hypothesis is that intravenous administration of ACMP will similarly disrupt central sensitization in facial pain as it does in migraine headaches.

Conditions

Facial Pain

Keywords

facial pain; CGRP; intravenous ACMP

Outcome Measures

Primary Outcomes (1)

• MIDAS score

  The MIDAS (Migraine Disability Assessment) questionnaire measures how much migraines affect your everyday life and activities: work, household activities, school responsibilities, and leisure activities over the past 3 months. The total score is obtained by summing the answers to the key questions (1-5). 1. Low scores (0-10): Grade I and II- mild, ittle or no disability. Migraines has no or slight imapct on activities, but overall functioning is mostly preserved. Basic treatment and lifestyle adjustments are usually sufficient. 2. Moderate scores (11-20): Grade III - moderate disability. Migraines significantly interfere with work and daily life; treatment adjustment may be needed.Consideration of preventive migraine therapy is advised. 3. High scores (21+): Grade IV - severe disability. Migraines greatly reduce the ability to perform daily activities; specialist evaluation Migraines significantly impair quality of life; evaluation and prevention are recommended.

  Change of baseline levels of MIDAS at 3 and 6 months after intervention.

Secondary Outcomes (1)

• Biomarkers of brain injury and inflammatory response

  Change of baseline levels of proinflamatory cytokines and specific biomarkers at 3 and 6 months after intervention.

Interventions

intravenous administration of ACMP DRUG

30-minute infusion of 100 mg of eptinezumab, repeated after three months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pain Therapy Clinic of University Medical Centre Ljubljana

You may qualify if:

• facial pain

You may not qualify if:

• psychiatric disease

Sponsors & Collaborators

• Alenka Spindler-Vesel: lead

Study Sites (1)

Pain Therapy Clinic of University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof., MD

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): November 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-11

Locations

SL (1)