Clinical trial NCT02957851: EMONO for the Treatment of Peripheral Neuropathic Pain
Official title: Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) for the Treatment of Peripheral Neuropathic Pain: A Randomises, International, Multicentre, Placebo-Controlled, Phenotype-stratified Phase IIa Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuralgia
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: AMS Advanced Medical Services GmbH
First posted: 2016-11-08
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Pain intensity
timeFrame: 7 days after the last administration of treatment
Secondary outcomes:
measure: Pain intensity
timeFrame: 28 days after the last administration of treatment
measure: Pain characteristic
timeFrame: 28 days after the last administration of treatment
measure: Quality of life questionnaire
timeFrame: 28 days after the last administration of treatment
measure: Number of patients with adverse events
timeFrame: through study duration, up to 31 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
state: La Tronche
city: Bayeux
country: France
facility: Centre Hospitalier de Bayeux
city: Besançon
country: France
facility: Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Bron
country: France
facility: Hopital Neurologique Weirthermer
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire Gabriel Montpied
city: Le Bourget
country: France
facility: Clinique du Bourget
city: Limoges
country: France
facility: Centre Hospitalier Universitaire Dupuytren
city: Marseille
country: France
facility: CHU la Timone
city: Metz-Thionville
country: France
facility: Centre Hospitalier Régional de Metz-Thionville
city: Montpellier
country: France
facility: Hôpital Saint Eloi
city: Nantes
country: France
facility: Clinique Brétéché
city: Nantes
country: France
facility: Hôpital Nord Laennec
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Nimes
country: France
facility: Hôpital Universitaire Caremeau
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Cochin
city: Rouen
country: France
facility: Centre hospitalier Universitaire de Rouen
city: Saint-Priest
country: France
facility: Clinique IRIS Saint-Priest
city: Würzburg
country: Germany
facility: Neurologische Klinik Universitätsklinikum
state: Josef-Schneider-Str. 11
city: Munchen
country: Germany
facility: Neurologische Klinik Klinikum rechts der Isar
Study officials:
affiliation: Hospital Ambroise Paré Paris
name: Didier Bouhassira, MD
role: STUDY_CHAIR
References:
citation: Bouhassira D, Perrot S, Attal N, Ramirez-Gil JF, Delval C, Schaller M, Bessiere B, Houeto P, Sommer C. Combination of inhaled nitrous oxide and oral opioids induces long-lasting analgesic effects in patients with neuropathic pain: ProtoTOP study post hoc exploratory analyses. Pain. 2022 Sep 1;163(9):e1021-e1029. doi: 10.1097/j.pain.0000000000002570. Epub 2021 Dec 20.
citation: Bouhassira D, Perrot S, Riant T, Martine-Fabre G, Pickering G, Maindet C, Attal N, Ranque Garnier S, Nguyen JP, Kuhn E, Viel E, Kieffert P, Tolle T, Delorme C, Deleens R, Ginies P, Corand-Dousset V, Dal-Col C, Serrie A, Chevrillon E, Gov C, Ramirez-Gil JF, Delval C, Schaller M, Bessiere B, Houeto P, Sommer C; ProtoTOP group. Safety and efficacy of an equimolar mixture of oxygen and nitrous oxide: a randomized controlled trial in patients with peripheral neuropathic pain. Pain. 2021 Apr 1;162(4):1104-1115. doi: 10.1097/j.pain.0000000000002109.