Complex Regional Pain Syndrome CRPS
Conditions
Interventions
Oral methadone, used within its existing marketing authorization as an opioid analgesic, is the only study drug. Dosing follows a start low, go slow titration schedule and may be adjusted or discontin
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age = 18 years• Meets the Valencia diagnostic criteria for CRPS• CRPS limited to one upper extremity or one lower extremity• Willing and capable of participating and able to provide informed consent• Treatment planned in an elective (non-urgent) setting• Adequate comprehension of the Dutch language
Exclusion criteria
Exclusion criteria: • Prior use of methadone for CRPS in the last year, for a duration of at least 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the within patient change in 11 point NRS pain score for the past 24 hours from baseline to week 12, in the as treated population that is participants still on methadone at week 12 with paired NRS data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include durability of analgesia up to week 24, treatment persistence and reasons for discontinuation, longitudinal methadone dose requirements, incidence and nature of treatment emergent AEs and SAEs, changes across COMPACT patient reported outcome domains and PGIC, and exploratory relationships between genotype defined metabolizer status, dose normalized trough levels and analgesic response. | — |
Countries
Netherlands
Contacts
Public ContactJ. Brink
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed