Treatment Peripheral Neuropathic Pain MedDRA version: 19.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Kalinox TM
Pharmaceutical Form: Medicinal gas, compressed
Pharmaceutical form of the placebo: Medicinal gas, compressed
Route of administrat
Sponsors
Air Liquide Santé International
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female patient aged 18 years or older -Definite or probable peripheral neuropathy confirmed by DN4 (score = 4) and NeuPSIG criteria (“definite” or “probable” levels) (see Appendix 2 and 3) -Neuropathic pain lasting for more than 3 months but less than 10 years -Pain intensity = 4 but = 9 as assessed on the 11-point NRS (Numeric Rating Scale) -Stable analgesic medications since at least 4 weeks prior the Selection visit V0 -Peripheral neuropathy with at least one of the following aetiologies : Post-traumatic or post-surgical nerve injury Polyneuropathy including diabetic neuropathy Post-herpetic neuralgia -Patient willing and able to complete the requirements of this study -Written informed consent signed and dated by the patient after full explanation of the study prior to any study related procedures 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 350 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: -Legal incapacity or limited legal capacity -Patient with another concomitant chronic pain -Ongoing major depression -Patient with ongoing litigation -Pregnancy or lactation -Severe terminal illness -Anticipated difficulties for administration of inhaled gas by mask (facial deformation that would make mask administration of inhaled gases inefficient) -Risk of need for high inhaled oxygen concentrations -Chronic respiratory failure requiring regular oxygen therapy -Ketamine administered within one week before selection -Hypnosis sessions (including self-hypnosis) or any other complementary medicine treatment planned during the study -Participation in a drug or device trial within the previous 30 days -Known contraindication to administration of Nitrous Oxide/Oxygen 50%/50% (EMONO) including documented and untreated vitamin B12 or folic acid deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change in mean pain intensity ;Timepoint(s) of evaluation of this end point: Between the 7-day baseline period (including pain intensity recorded in the morning before Inclusion visit ) and the first 7-day after the last administration of treatment ;Main Objective: To assess the effect of 3 consecutive days of one-hour administration of Nitrous Oxide/Oxygen 50%/50% (EMONO) versus placebo as Oxygen/Nitrogen 22%/78% (synthetic medical air), in add-on therapy to chronic analgesic treatments, on average pain intensity in patients with chronic peripheral neuropathic pain. ; Secondary Objective: -To assess the magnitude and long-term effect on pain intensity over a 28 days period after treatment administration -To characterise the treatment response according to the sensory phenotype profile, i.e. evoked/non evoked pain -To assess the treatment effects on pain characteristics -To assess the treatment effects on quality of life -To assess the need for rescue therapy -To assess safety during the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evolution of pain intensity by NRS;Timepoint(s) of evaluation of this end point: up to 28 days after treatment administration | — |
Countries
France, Germany
Contacts
Public ContactMedical R&D Vice President
Air Liquide Santé International
Outcome results
None listed