EMONO for the Treatment of Peripheral Neuropathic Pain

Phase 2

Completed

• Conditions: Neuralgia
• Interventions: Drug: EMONO; Drug: Medical Air

• Registration Number: NCT02957851
• Lead Sponsor: Air Liquide Santé International

Brief Summary

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. A total of 250 randomised patients to be included in all the participating centres, i.e., 125 randomised patients in each of the 2 study groups treatments

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-20
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• Patients with a mean pain intensity from 4 to 9 as assessed daily with a Numerating Rating Scale during the 7 day period preceding inclusion in spite of administration of usual pain treatments.
• Neuropathic pain lasting for more than 3 months but less than 10 years
• Definite or probable peripheral neuropathy

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Exclusion Criteria

• legal incapacity
• patient with another concomitant chronic pain
• ongoing major depression
• Chemotherapy-induced peripheral neuropathic pain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitrous Oxide/Oxygen (50%/50%)	EMONO	EMONO
Oxygen/Nitrogen (22%/78%)	Medical Air	Medical Air

Primary Outcome Measures

Name	Time	Method
Pain intensity	7 days after the last administration of treatment	Numeric Rating Scale (NRS)

Secondary Outcome Measures

Name	Time	Method
Pain intensity	28 days after the last administration of treatment	Numeric Rating Scale (NRS)
Pain characteristic	28 days after the last administration of treatment	Neuropathic Pain Symptom Inventory (NPSI)
Quality of life questionnaire	28 days after the last administration of treatment	Medical Outcome Study Short Form (SF-12)
Number of patients with adverse events	through study duration, up to 31 days

Trial Locations

Locations (22)

Hôpital Ambroise Paré; 🇫🇷 Boulogne-Billancourt, France

CHU de Grenoble; 🇫🇷 Grenoble, La Tronche, France

Clinique du Bourget; 🇫🇷 Le Bourget, France

Centre Hospitalier de Bayeux; 🇫🇷 Bayeux, France

Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Centre Hospitalier Universitaire Dupuytren; 🇫🇷 Limoges, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Nouvelles Cliniques Nantaises; 🇫🇷 Nantes, France

Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz; 🇫🇷 Besançon, France

Hopital Neurologique Weirthermer; 🇫🇷 Bron, France

Centre Hospitalier Universitaire Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Hôpital Saint Eloi; 🇫🇷 Montpellier, France

CHU la Timone; 🇫🇷 Marseille, France

Centre hospitalier Universitaire de Rouen; 🇫🇷 Rouen, France

Centre Hospitalier Régional de Metz-Thionville; 🇫🇷 Metz-Thionville, France

Clinique Brétéché; 🇫🇷 Nantes, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Nord Laennec; 🇫🇷 Nantes, France

Hôpital Universitaire Caremeau; 🇫🇷 Nimes, France

Clinique IRIS Saint-Priest; 🇫🇷 Saint-Priest, France

Neurologische Klinik Klinikum rechts der Isar; 🇩🇪 Munchen, Germany

Neurologische Klinik Universitätsklinikum; 🇩🇪 Würzburg, Josef-Schneider-Str. 11, Germany