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Ketamine's Efficiency in the Treatment of Chronic Pain: Kynurenin Pathway

NCT03513822 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-05-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ketamine 10 MG/ML

Ketamine infusion 1mg/kg with electric syringe during 2 hours.

DRUG

Placebos

Sodium chloride infusion with the same rate, electric syringe during 2 hours.

DRUG

Midazolam 1 MG/ML

Bolus of Midazolam 1mg before each perfusion.

Sponsors & Collaborators

  • Hôpital Raymond Poincaré

    collaborator OTHER

  • Hopital Lariboisière

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Fondation Apicil

    collaborator OTHER

  • Hospital Ambroise Paré Paris

    collaborator OTHER

  • Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

    collaborator OTHER

  • Redar

    lead OTHER

Principal Investigators

  • Didier Bouhassira, Md, PhD · INSERM U987

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-16
Primary Completion
2018-10-31
Completion
2018-11-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03513822 on ClinicalTrials.gov