EMONO for the Treatment of Peripheral Neuropathic Pain (ProtoTOP)

September 20, 2018 updated by: Air Liquide Santé International

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

287

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bayeux, France, 14401
        • Centre Hospitalier de Bayeux
      • Besançon, France, 25030
        • Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz
      • Bordeaux, France, 33000
        • Hôpital Pellegrin
      • Boulogne-Billancourt, France, 92100
        • Hopital Ambroise Pare
      • Bron, France, 69677
        • Hopital Neurologique Weirthermer
      • Clermont-Ferrand, France, 63003
        • Centre Hospitalier Universitaire Gabriel Montpied
      • Le Bourget, France, 93350
        • Clinique du Bourget
      • Limoges, France, 87042
        • Centre Hospitalier Universitaire Dupuytren
      • Marseille, France, 13385
        • CHU La Timone
      • Metz-Thionville, France, 57530
        • Centre Hospitalier Régional de Metz-Thionville
      • Montpellier, France, 34295
        • Hopital Saint Eloi
      • Nantes, France, 44093
        • Hôpital Nord Laennec
      • Nantes, France, 44046
        • Clinique Breteche
      • Nantes, France, 44202
        • Nouvelles Cliniques Nantaises
      • Nimes, France, 30029
        • Hôpital Universitaire Carémeau
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75014
        • Hopital Cochin
      • Rouen, France, 76000
        • Centre Hospitalier Universitaire de Rouen
      • Saint-Priest, France, 69800
        • Clinique IRIS Saint-Priest
    • La Tronche
      • Grenoble, La Tronche, France, 38700
        • Chu de Grenoble
  • Germany
      • Munchen, Germany, 81675
        • Neurologische Klinik Klinikum rechts der Isar
    • Josef-Schneider-Str. 11
      • Würzburg, Josef-Schneider-Str. 11, Germany, 97080
        • Neurologische Klinik Universitätsklinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Oxygen/Nitrogen (22%/78%)
Medical Air
Drug: Medical Air
Other Names:
  • Oxygen/Nitrogen
ACTIVE_COMPARATOR: Nitrous Oxide/Oxygen (50%/50%)
EMONO
Drug: EMONO
Other Names:
  • Nitrous Oxide/Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 7 days after the last administration of treatment
Numeric Rating Scale (NRS)
7 days after the last administration of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Liquide Santé International

Collaborators

AMS Advanced Medical Services GmbH

Investigators

  • Study Chair: Didier Bouhassira, MD, Hospital Ambroise Paré Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (ESTIMATE)

November 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALMED-15-C2-054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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