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EMONO for the Treatment of Peripheral Neuropathic Pain (ProtoTOP)

Primary Purpose

Neuralgia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Medical Air

EMONO

About this trial

This is an interventional treatment trial for Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU de Grenoble
Centre Hospitalier de Bayeux
Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz
Hôpital Pellegrin
Hôpital Ambroise Paré
Hopital Neurologique Weirthermer
Centre Hospitalier Universitaire Gabriel Montpied
Clinique du Bourget
Centre Hospitalier Universitaire Dupuytren
CHU la Timone
Centre Hospitalier Régional de Metz-Thionville
Hôpital Saint Eloi
Clinique Brétéché
Hôpital Nord Laennec
Nouvelles Cliniques Nantaises
Hôpital Universitaire Caremeau
Hôpital Lariboisière
Hôpital Cochin
Centre hospitalier Universitaire de Rouen
Clinique IRIS Saint-Priest
Neurologische Klinik Universitätsklinikum
Neurologische Klinik Klinikum rechts der Isar

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Oxygen/Nitrogen (22%/78%)

Nitrous Oxide/Oxygen (50%/50%)

Arm Description

Medical Air

EMONO

Outcomes

Primary Outcome Measures

Pain intensity

Numeric Rating Scale (NRS)

Secondary Outcome Measures

Pain intensity

Numeric Rating Scale (NRS)

Pain characteristic

Neuropathic Pain Symptom Inventory (NPSI)

Quality of life questionnaire

Medical Outcome Study Short Form (SF-12)

Number of patients with adverse events

Full Information

NCT ID

NCT02957851

First Posted

October 20, 2016

Last Updated

September 20, 2018

Sponsor

Air Liquide Santé International

Collaborators

AMS Advanced Medical Services GmbH

1. Study Identification

Unique Protocol Identification Number

NCT02957851

Brief Title

EMONO for the Treatment of Peripheral Neuropathic Pain

Acronym

ProtoTOP

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

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Air Liquide Santé International

Collaborators

AMS Advanced Medical Services GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuralgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

287 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxygen/Nitrogen (22%/78%)

Arm Type

Placebo Comparator

Arm Description

Medical Air

Arm Title

Nitrous Oxide/Oxygen (50%/50%)

Arm Type

Active Comparator

Arm Description

EMONO

Intervention Type

Drug

Intervention Name(s)

Medical Air

Other Intervention Name(s)

Oxygen/Nitrogen

Intervention Type

Drug

Intervention Name(s)

EMONO

Other Intervention Name(s)

Nitrous Oxide/Oxygen

Primary Outcome Measure Information:

Title

Pain intensity

Description

Numeric Rating Scale (NRS)

Time Frame

7 days after the last administration of treatment

Secondary Outcome Measure Information:

Title

Pain intensity

Description

Numeric Rating Scale (NRS)

Time Frame

28 days after the last administration of treatment

Title

Pain characteristic

Description

Neuropathic Pain Symptom Inventory (NPSI)

Time Frame

28 days after the last administration of treatment

Title

Quality of life questionnaire

Description

Medical Outcome Study Short Form (SF-12)

Time Frame

28 days after the last administration of treatment

Title

Number of patients with adverse events

Time Frame

through study duration, up to 31 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Didier Bouhassira, MD

Organizational Affiliation

Hospital Ambroise Paré Paris

Official's Role

Study Chair

Facility Information:

Facility Name

CHU de Grenoble

City

Grenoble

State/Province

La Tronche

ZIP/Postal Code

38700

Country

France

Facility Name

Centre Hospitalier de Bayeux

City

Bayeux

ZIP/Postal Code

14401

Country

France

Facility Name

Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz

City

Besançon

ZIP/Postal Code

25030

Country

France

Facility Name

Hôpital Pellegrin

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

Hôpital Ambroise Paré

City

Boulogne-Billancourt

ZIP/Postal Code

92100

Country

France

Facility Name

Hopital Neurologique Weirthermer

City

Bron

ZIP/Postal Code

69677

Country

France

Facility Name

Centre Hospitalier Universitaire Gabriel Montpied

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

Clinique du Bourget

City

Le Bourget

ZIP/Postal Code

93350

Country

France

Facility Name

Centre Hospitalier Universitaire Dupuytren

City

Limoges

ZIP/Postal Code

87042

Country

France

Facility Name

CHU la Timone

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Centre Hospitalier Régional de Metz-Thionville

City

Metz-Thionville

ZIP/Postal Code

57530

Country

France

Facility Name

Hôpital Saint Eloi

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Clinique Brétéché

City

Nantes

ZIP/Postal Code

44046

Country

France

Facility Name

Hôpital Nord Laennec

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Nouvelles Cliniques Nantaises

City

Nantes

ZIP/Postal Code

44202

Country

France

Facility Name

Hôpital Universitaire Caremeau

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

Hôpital Lariboisière

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Hôpital Cochin

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Centre hospitalier Universitaire de Rouen

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

Clinique IRIS Saint-Priest

City

Saint-Priest

ZIP/Postal Code

69800

Country

France

Facility Name

Neurologische Klinik Universitätsklinikum

City

Würzburg

State/Province

Josef-Schneider-Str. 11

ZIP/Postal Code

97080

Country

Germany

Facility Name

Neurologische Klinik Klinikum rechts der Isar

City

Munchen

ZIP/Postal Code

81675

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35050957

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.

Results Reference

derived

PubMed Identifier

33044394

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.

Results Reference

derived

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EMONO for the Treatment of Peripheral Neuropathic Pain

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