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NCT05212571: KetCRPS-2

Long-term Pain Modulation by Intravenous Esketamine in CRPS

ENROLLING BY INVITATION NA Last updated 11 September 2023
What this trial tests

NA trial testing S-ketamine infusion inpatient setting in Complex Regional Pain Syndromes in 60 participants. Enrolling by invitation.

Timeline
19 April 2022
Primary endpoint
1 October 2026
1 October 2027

Quick facts

Lead sponsorErasmus Medical Center
PhaseNA
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment60
Start date19 April 2022
Primary completion1 October 2026
Estimated completion1 October 2027
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Erasmus Medical Center

Who can join

18 and older, any sex, with Complex Regional Pain Syndromes or CRPS (Complex Regional Pain Syndromes). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intravenous administration of esketamine is an effective recognized therapeutic option in refractory pain in CRPS, which sometimes in at least a part of the patients has a prolonged therapeutic effect. Unfortunately, CRPS literature contains a wide range of ketamine dosing regimens with the result that clinical protocols on dosage and administration are very heterogeneous. The current esketamine regimen in Erasmus MC consists of a 6-day hospital admission for continuous administration. In the Netherlands, both inpatient and outpatient esketamine treatments are offered. Inpatient and outpatient ketamine treatments have never been compared in randomized controlled trials and it is therefore unknown whether these two dosing regimens are equally effective. The primary objective is to demonstrate non-inferiority of experimental esketamine administration of 6x 1 day per 2 weeks (in total 3 months) as compared with standard esketamine administration of 1x 6 consecutive days. The end of study is at 6 months after the start of the study/treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Intermittent versus continuous esketamine infusions for long-term pain modulation in complex regional pain syndrome: protocol of a randomized controlled non-inferiority study (KetCRPS-2).
    Mangnus TJP, Dirckx M, Bharwani KD, Baart SJ, et al · · 2023 · cited 3× · PMID 36991381 · DOI 10.1186/s12891-023-06258-4

Verify or expand the search:

Other recruiting trials for Complex Regional Pain Syndromes

Currently open trials in the same condition.

Other Erasmus Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05212571.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing