EMONO for the Treatment of Peripheral Neuropathic Pain
ProtoTOP
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
1 other identifier
interventional
287
2 countries
22
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2016
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedSeptember 21, 2018
September 1, 2018
1.7 years
October 20, 2016
September 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity
Numeric Rating Scale (NRS)
7 days after the last administration of treatment
Secondary Outcomes (4)
Pain intensity
28 days after the last administration of treatment
Pain characteristic
28 days after the last administration of treatment
Quality of life questionnaire
28 days after the last administration of treatment
Number of patients with adverse events
through study duration, up to 31 days
Study Arms (2)
Oxygen/Nitrogen (22%/78%)
PLACEBO COMPARATORMedical Air
Nitrous Oxide/Oxygen (50%/50%)
ACTIVE COMPARATOREMONO
Interventions
Eligibility Criteria
You may qualify if:
- Neuropathic pain lasting for more than 3 months but less than 10 years
- Definite or probable peripheral neuropathy
You may not qualify if:
- legal incapacity
- patient with another concomitant chronic pain
- ongoing major depression
- Chemotherapy-induced peripheral neuropathic pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
CHU de Grenoble
Grenoble, La Tronche, 38700, France
Centre Hospitalier de Bayeux
Bayeux, 14401, France
Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz
Besançon, 25030, France
Hôpital Pellegrin
Bordeaux, 33000, France
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100, France
Hopital Neurologique Weirthermer
Bron, 69677, France
Centre Hospitalier Universitaire Gabriel Montpied
Clermont-Ferrand, 63003, France
Clinique du Bourget
Le Bourget, 93350, France
Centre Hospitalier Universitaire Dupuytren
Limoges, 87042, France
CHU la Timone
Marseille, 13385, France
Centre Hospitalier Régional de Metz-Thionville
Metz-Thionville, 57530, France
Hôpital Saint Eloi
Montpellier, 34295, France
Clinique Brétéché
Nantes, 44046, France
Hôpital Nord Laennec
Nantes, 44093, France
Nouvelles Cliniques Nantaises
Nantes, 44202, France
Hôpital Universitaire Caremeau
Nîmes, 30029, France
Hôpital Lariboisière
Paris, 75010, France
Hôpital Cochin
Paris, 75014, France
Centre hospitalier Universitaire de Rouen
Rouen, 76000, France
Clinique IRIS Saint-Priest
Saint-Priest, 69800, France
Neurologische Klinik Universitätsklinikum
Würzburg, Josef-Schneider-Str. 11, 97080, Germany
Neurologische Klinik Klinikum rechts der Isar
München, 81675, Germany
Related Publications (2)
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.
PMID: 35050957DERIVEDBouhassira 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.
PMID: 33044394DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Didier Bouhassira, MD
Hospital Ambroise Paré Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2016
First Posted
November 8, 2016
Study Start
November 1, 2016
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
September 21, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share