Fremanezumab for pain in Complex Regional Pain Syndrome

Phase 1

Recruiting

• Conditions: Complex Regional Pain Syndrome; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2022-503167-15-00
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age between 18 and 75 years., Confirmed CRPS (type I or II) diagnosed according to the International Association of Pain (IASP) diagnostic criteria of CRPS (Budapest criteria) with adaption to research, Disease lasting from 3-18 months, Mean ADP score of at least 4 on a 11-point NRS scale ranging from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable during the baseline week, Written informed consent.

Exclusion Criteria

Other causes of pain and/or inflammation in the same area as CRPS or other concomitant pain/inflammation that cannot be distinguished from CRPS., Significant severe disease, Spreading of the CRPS to other extremities according to IASP criteria for spreading of CRPS, Initiation of new pain medication or corticosteroids., Poor compliance or patients who cannot cooperate or are unable to be able to complete the project and language difficulties., Depression or other significant psychiatric disease, alcohol or drug abuse., Pregnancy or lactation., Women of child-bearing potential unless they use an acceptable effective contraception measure during the study and at least 6 months after or their male partner is vasectomized and their sole partner., Known allergy to any component of fremanezumab., Planned surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to compare the change in pain intensity from baseline to last week of fremanezumab treatment to placebo treatment in patients with CRPS.;Secondary Objective: To assess pain relief and differences in clinical signs of the disease and function between the groups and if the effect can be predicted by CGRP biomarkers.;Primary end point(s): Difference between groups (placebo vs. active treatment) in the change in self-reported daily ratings of mean average daily pain intensity (ADP) in the affected limb from the baseline week to the last week of treatment, as experienced during the past 24 hours, rated on a 0–10-point numeric rating scale (NRS; 0 = no pain, 10 = worst possible pain).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Difference in Pain relief on a 6-point scale: complete, good, moderate, mild, none, worse.;Secondary end point(s):Difference in the change in mean CRPS severity score (CSS) from end of baseline to end of week 4 and 8.;Secondary end point(s):Differences in the area and intensity of mechanical allodynia, assessed by brushing a soft brush (Somedic) twice with a speed of 1-2 cm/s;Secondary end point(s):The relationship between the primary outcome measure and the duration of CRPS (measured in months).