Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
60
Countries
1
Sites
1
Complex regional pain syndrome
The aim of this study is to assess whether a series of esketamine infusions, every 2 weeks for 3 months, in a day treatment setting, is non-inferior at 3 months after the start of the treatment to the standard treatment of a 6-day clinical admission of continuous esketamine administration.
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 22 Apr 2024 → ongoing
- Decision date (initial)
- 2024-04-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Erasmus MC
External identifiers
- EU CT number
- 2024-511877-31-00
- EudraCT number
- 2021-000640-21
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The aim of this study is to assess whether a series of esketamine infusions, every 2 weeks for 3 months, in a day treatment setting, is non-inferior at 3 months after the start of the treatment to the standard treatment of a 6-day clinical admission of continuous esketamine administration.
Secondary objectives 6
- 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
- NRS-pain scores over time till 6 months follow-up
- Dose reduction of pain medication at follow up
Conditions and MedDRA coding
Complex regional pain syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10064332 | Complex regional pain syndrome | 100000004852 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age ≥ 18 years
- Meeting the new International Association for the Study of Pain (IASP) diagnostic criteria for CRPS (“the Budapest Criteria) or having met the new IASP diagnostic criteria of CRPS (“CRPS with Remission of Some features”)
- 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
- Adequate comprehension of the Dutch language
Exclusion criteria 1
- Contraindications to and precautions for use of subanesthetic doses of ketamine for chronic pain are listed by Cohen et al. and the Dutch CRPS guidelines and our clinical protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pain intensity measured by Numerical Rating Scale (NRS). The current NRS score reflecting the pain intensity at the moment when asked and the average NRS score of the last 24 hours. (T0, T3, T4)
Secondary endpoints 10
- 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. (T1, T2)
- Number and severity of intervention related adverse events: Psychomimetic (dysphoria, euphoria, hallucinations, nightmares and vivid dreams, anxiety, agitation), blurry vision or diplopia, nausea and / or vomiting, sedation, hepatic toxicity, headache and dislocation of peripheral intravenous catheter (T1, T2)
- Number of administered co-interventions related to adverse events (benzodiazepines, clonidine, granisetron). (T1)
- NRS pain scores over time till follow-up T3. The current NRS score reflecting the pain intensity at the moment when asked by telephone and the average NRS score of the last 24 hours. (T1, T2)
- 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-lymphocyte and macrophage activation, respectively. In addition, T cell populations and monocyte populations will be identified using flow cytometry. (T0, T3)
- To assess the sensory-discriminative dimensions of pain before and after ketamine treatment; Quantitative Sensory Testing (T0, T3)
- Objectively measured effects of each of the administration regimens on symptoms vasomotor disturbances; Thermography (T0, T3)
- Dose reduction of pain medication at follow after three months and six months (T3, T4)
- CRPS symptoms and signs based on the Budapest diagnostic clinical criteria; CRPS severity score (20). (T0, T3)
- Questionnaires COMPACT (Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies) (42, 43):
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Ketanest® S 25 mg/ml - Ampullen
PRD412849 · Product
- Active substance
- Esketamine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 0.2 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01AX14 — ESKETAMINE
- Marketing authorisation
- 1-22525
- MA holder
- PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ketanest® S 5 mg/ml - Ampullen
PRD392897 · Product
- Active substance
- Esketamine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 0.2 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01AX14 — ESKETAMINE
- Marketing authorisation
- 1-22524
- MA holder
- PFIZER CORPORATION AUSTRIA GES.M.B.H.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- F.J.P.M. Huygen
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- F.J.P.M. Huygen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Anesthesiology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-04-22 | 2024-04-22 | 2025-12-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-10 | Netherlands | Acceptable 2024-04-22
|
2024-04-22 |