Treatment of Peripheral Neuropathic Pain

Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) for the Treatment of Peripheral Neuropathic Pain: a Randomised, International, Multicentre, Placebo-Controlled, Phenotype-stratified Phase IIa Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004779-64-DE

Enrollment

250

Registered

2016-07-22

Start date

2016-12-20

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Treatment Peripheral Neuropathic Pain MedDRA version: 20.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852

Interventions

Trade Name: Kalinox TM Pharmaceutical Form: Medicinal gas, compressed INN or Proposed INN: Nitrous oxide CAS Number: 10024-97-2 Other de

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 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Legal incapacity or limited legal capacity -Chronic pain with mixed mechanisms, including inflammatory process such as radiculopathy -Patient with another co-located or not distinct concomitant chronic pain -Ongoing major depression -Patient with psychiatric disorders (schizophrenia, bipolar disorder... -Patient with drug addiction -Chemotherapy-induced peripheral neuropathic pain -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 4 weeks before selection -Any complementary medicine treatment (including hypnosis sessions) not stable within 4 weeks before selection -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 (serum level) or folic acid (serum and red blood cell levels) deficiency

Design outcomes

Primary

Measure	Time frame
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 study 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 "on demand" and/or rescue therapies -To assess safety during the study ;Primary end point(s): Change in mean pain intensity (assessed by NRS);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	—

Measure

Time frame

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 study 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 "on demand" and/or rescue therapies -To assess safety during the study ;Primary end point(s): Change in mean pain intensity (assessed by NRS);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

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: up to 28 days after the last study treatment administration; Secondary end point(s): Evolution of pain intensity by NRS - Proportion of patients with 1-point decrease in NRS scale at different time points - Time to reach a 1-point decrease in NRS scale - Duration of the 1-point decrease in NRS scale	—

Countries

France, Germany

Contacts

Public ContactMedical R&D Vice President

Air Liquide Santé International

juan-fernando.ramirez@airliquide.com330139076342

Outcome results

None listed

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