Esketamine via the bloodstream for Complex Regional Pain Syndrome

Long-term pain modulation by intravenous esketamine in Complex Regional Pain Syndrome: a non-inferiority study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000640-21-NL

Enrollment

Registered

2021-08-03

Start date

2021-11-10

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

Complex Regional Pain Syndrome

Interventions

Trade Name: Ketanest-S Product Name: Esketamine Product Code: Esketamine Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age = 18 years. - Meeting or having met the Budapest Criteria of CRPS (Harden, 2010) - Willing and capable to participate in the study. - CRPS in one upper extremity and/or CRPS in one lower extremity - Treatment in an elective setting. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Inadequate comprehension of the Dutch language - Pregnancy - Unstable angina, poorly controlled hypertension, high-risk coronary vascular disease - Severe liver disease - Elevated intracranial pressure - Elevated intraocular pressure, acute globe injury, or glaucoma - Thyrotoxicosis - Pheochromocytoma - Active substance abuse - Psychosis or delirium - Refusal or inability to consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to assess whether a series of esketamine infusions, once a week for a period of six weeks, in a day treatment setting, is non-inferior to the standard treatment of a 6-day clinical admission of continuous esketamine administration. ;Secondary Objective: •Number and severity of intervention related adverse events in each of the esketamine administration regimens •To assess protocol deviations due to logistical problems for each of the administration regimens •Physiological measures: Questionnaires COMPACT (Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies) •Objective measures: Quantitative Sensory Testing (QST), thermography, serum levels and cellular immunity samples •Dose reduction of pain medication at follow up ;Primary end point(s): Pain intensity measured by Numerical Rating Scale (NRS): -The average NRS score of the last 24 hours -The current NRS score reflecting the pain intensity at the moment when asked ;Timepoint(s) of evaluation of this end point: T0= Baseline, before ketamine administration T1= After last esketamine treatment T2= Three months after esktemine administration	—

Measure

Time frame

Main Objective: The aim of this study is to assess whether a series of esketamine infusions, once a week for a period of six weeks, in a day treatment setting, is non-inferior to the standard treatment of a 6-day clinical admission of continuous esketamine administration. ;Secondary Objective: •Number and severity of intervention related adverse events in each of the esketamine administration regimens •To assess protocol deviations due to logistical problems for each of the administration regimens •Physiological measures: Questionnaires COMPACT (Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies) •Objective measures: Quantitative Sensory Testing (QST), thermography, serum levels and cellular immunity samples •Dose reduction of pain medication at follow up ;Primary end point(s): Pain intensity measured by Numerical Rating Scale (NRS): -The average NRS score of the last 24 hours -The current NRS score reflecting the pain intensity at the moment when asked ;Timepoint(s) of evaluation of this end point: T0= Baseline, before ketamine administration T1= After last esketamine treatment T2= Three months after esktemine administration

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Secondary

Measure	Time frame
Secondary end point(s): - To assess protocol deviations due to logistical problems for each of the administration regimens: premature termination (due to i.e. bed capacity problems), waiting time for therapy (weeks) and compliance of the patients. - Number and severity of intervention related adverse events: Psychomimetic (dysphoria, hallucinations, nightmares and vivid dreams), blurry vision or diplopia, nausea and / or vomiting, hepatic toxicity, headache and dislocation of peripheral intravenous catheter - Objectively measured effects of each of the administration regimens on the inflammation; serum levels of sIL-2R and sCD163 will be detected with Enzyme Linked Immunosorbent Assay (ELISA) as measures for T-lymhpocyte and macrophage activation, respectively. In addition, T cell populations and monocyte populations will be identified using flow cytometry. - To assess the sensory-discriminative dimensions of pain before and after ketamine treatment; Quantitative Sensory Testing - Objectively measured effects of each of the administration regimens on symptoms vasomotor disturbances; Thermography - Dose reduction of pain medication at follow after three months (yes/no) - CRPS severity score {Harden, 2010 #184}. CRPS symptoms and signs based on the Budapest diagnostic clinical criteria. ;Timepoint(s) of evaluation of this end point: T0= Baseline, before ketamine administration T1= After last esketamine treatment T2= Three months after esktemine administration	—

Measure

Time frame

Secondary end point(s): - To assess protocol deviations due to logistical problems for each of the administration regimens: premature termination (due to i.e. bed capacity problems), waiting time for therapy (weeks) and compliance of the patients. - Number and severity of intervention related adverse events: Psychomimetic (dysphoria, hallucinations, nightmares and vivid dreams), blurry vision or diplopia, nausea and / or vomiting, hepatic toxicity, headache and dislocation of peripheral intravenous catheter - Objectively measured effects of each of the administration regimens on the inflammation; serum levels of sIL-2R and sCD163 will be detected with Enzyme Linked Immunosorbent Assay (ELISA) as measures for T-lymhpocyte and macrophage activation, respectively. In addition, T cell populations and monocyte populations will be identified using flow cytometry. - To assess the sensory-discriminative dimensions of pain before and after ketamine treatment; Quantitative Sensory Testing - Objectively measured effects of each of the administration regimens on symptoms vasomotor disturbances; Thermography - Dose reduction of pain medication at follow after three months (yes/no) - CRPS severity score {Harden, 2010 #184}. CRPS symptoms and signs based on the Budapest diagnostic clinical criteria. ;Timepoint(s) of evaluation of this end point: T0= Baseline, before ketamine administration T1= After last esketamine treatment T2= Three months after esktemine administration

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Countries

Netherlands

Contacts

Public ContactTom Mangnus

Erasmus MC

t.mangnus@erasmusmc.nl+31107040704

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026