EMONO for the Treatment of Peripheral Neuropathic Pain

Neuralgia Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957851
• Other study ID #: ALMED-15-C2-054
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia

Intervention

Drug:
• Medical Air

• EMONO

Locations

Country	Name	City	State
France	Centre Hospitalier de Bayeux	Bayeux
France	Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz	Besançon
France	Hôpital Pellegrin	Bordeaux
France	Hôpital Ambroise Paré	Boulogne-Billancourt
France	Hopital Neurologique Weirthermer	Bron
France	Centre Hospitalier Universitaire Gabriel Montpied	Clermont-Ferrand
France	CHU de Grenoble	Grenoble	La Tronche
France	Clinique du Bourget	Le Bourget
France	Centre Hospitalier Universitaire Dupuytren	Limoges
France	CHU la Timone	Marseille
France	Centre Hospitalier Régional de Metz-Thionville	Metz-Thionville
France	Hôpital Saint Eloi	Montpellier
France	Clinique Brétéché	Nantes
France	Hôpital Nord Laennec	Nantes
France	Nouvelles Cliniques Nantaises	Nantes
France	Hôpital Universitaire Caremeau	Nimes
France	Hôpital Cochin	Paris
France	Hôpital Lariboisière	Paris
France	Centre hospitalier Universitaire de Rouen	Rouen
France	Clinique IRIS Saint-Priest	Saint-Priest
Germany	Neurologische Klinik Klinikum rechts der Isar	Munchen
Germany	Neurologische Klinik Universitätsklinikum	Würzburg	Josef-Schneider-Str. 11

Sponsors (2)

Lead Sponsor	Collaborator
Air Liquide Santé International	Advanced Medical Services GmBh - AMS

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Numeric Rating Scale (NRS)	7 days after the last administration of treatment
Secondary	Pain intensity	Numeric Rating Scale (NRS)	28 days after the last administration of treatment
Secondary	Pain characteristic	Neuropathic Pain Symptom Inventory (NPSI)	28 days after the last administration of treatment
Secondary	Quality of life questionnaire	Medical Outcome Study Short Form (SF-12)	28 days after the last administration of treatment
Secondary	Number of patients with adverse events		through study duration, up to 31 days