Ketamine's Efficiency in the Treatment of Chronic Pain: Kynurenin Pathway
Unknown statusPhase 3NCT03513822
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The kynurenine pathway is involved in hyperalgesia. This pathway is activated by inflammation. Ketamine would interact with the kynurenine pathway and inflammation. Our working hypotheses are: the clinical effects of ketamine on neuropathic pain are greater in the presence of systemic inflammation and the mechanism of action involves an interaction on the kynurenine pathway. Study design: Interventional randomized placebo-controlled clinical trial. Main goals: 1. To show a better clinical efficacy of ketamine in chronic pain in patients with an inflammatory component. 2. Explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.
Study details
- Official title
- Ketamine's Efficiency in the Treatment of Chronic Pain With an Added Inflammatory Component Exploring the Kynurenin Pathway. A Randomized, Double Blind, Placebo-controlled Trial
- Conditions
- Interventions
- Drug: Ketamine 10 MG/ML
- Drug: Placebos
- Drug: Midazolam 1 MG/ML
- Sponsor
- Redar
- Collaborators
- Hôpital Raymond Poincaré; Hopital Lariboisière; Institut National de la Santé Et de la Recherche Médicale, France; Fondation Apicil; Hospital Ambroise Paré Paris; Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
- Start date
- 2018-02-16
- Primary completion
- 2018-10
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adults speaking and understanding French * presenting chronic neuropathic pain as defined by IASP * Painful intensity\> or = to 6/10 during the week preceding the inclusion - Medullary lesion, whatever the origin (traumatic, degenerative, tumoral, postoperative), responsible for paraplegia in a chronic state. * Able to give informed consent, after clear, fair and appropriate information * Having given their consent by a written consent signature. Exclusion Criteria: * Hypersensitivity to ketamine or any of its components * Participation in another interventional trial, or participation in another trial. * Patient unable to give consent. * Pregnancy or breastfeeding * Refusal to sign the consent * Cardiovascular diseases associated in particular with disorders of rhythm and severe cardiac insufficiency, coronary insufficiency, discovered on examination, on ECG or by biological balance or known. - unstabilized HTA\> 180/100 mmHg * Severe hepatic and / or renal hepatic insufficiency.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03513822