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The effect of fremanezumab on pain in patients with Complex Regional Pain Syndrome: a randomized, double-blind, proof of concept, placebo-controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-503167-15-00
Enrollment
60
Registered
2023-06-08
Start date
2023-12-11
Completion date
Unknown
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome

Brief summary

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).

Detailed description

Difference in Pain relief on a 6-point scale: complete, good, moderate, mild, none, worse., Difference in the change in mean CRPS severity score (CSS) from end of baseline to end of week 4 and 8., 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, The relationship between the primary outcome measure and the duration of CRPS (measured in months).

Interventions

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Difference in Pain relief on a 6-point scale: complete, good, moderate, mild, none, worse., Difference in the change in mean CRPS severity score (CSS) from end of baseline to end of week 4 and 8., 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, The relationship between the primary outcome measure and the duration of CRPS (measured in months).

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026