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EMONO for the Treatment of Peripheral Neuropathic Pain (ProtoTOP)

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ClinicalTrials.gov Identifier: NCT02957851
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
AMS Advanced Medical Services GmbH
Information provided by (Responsible Party):
Air Liquide Santé International

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

Condition or disease Intervention/treatment Phase
Neuralgia Drug: Medical Air Drug: EMONO Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : November 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Placebo Comparator: Oxygen/Nitrogen (22%/78%)
Medical Air
Drug: Medical Air
Other Name: Oxygen/Nitrogen

Active Comparator: Nitrous Oxide/Oxygen (50%/50%)
EMONO
Drug: EMONO
Other Name: Nitrous Oxide/Oxygen




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 7 days after the last administration of treatment ]
    Numeric Rating Scale (NRS)


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 28 days after the last administration of treatment ]
    Numeric Rating Scale (NRS)

  2. Pain characteristic [ Time Frame: 28 days after the last administration of treatment ]
    Neuropathic Pain Symptom Inventory (NPSI)

  3. Quality of life questionnaire [ Time Frame: 28 days after the last administration of treatment ]
    Medical Outcome Study Short Form (SF-12)

  4. Number of patients with adverse events [ Time Frame: through study duration, up to 31 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957851


Locations
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France
CHU de Grenoble
Grenoble, La Tronche, France, 38700
Centre Hospitalier de Bayeux
Bayeux, France, 14401
Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz
Besançon, France, 25030
Hôpital Pellegrin
Bordeaux, France, 33000
Hôpital Ambroise Paré
Boulogne-Billancourt, France, 92100
Hopital Neurologique Weirthermer
Bron, France, 69677
Centre Hospitalier Universitaire Gabriel Montpied
Clermont-Ferrand, France, 63003
Clinique du Bourget
Le Bourget, France, 93350
Centre Hospitalier Universitaire Dupuytren
Limoges, France, 87042
CHU la Timone
Marseille, France, 13385
Centre Hospitalier Régional de Metz-Thionville
Metz-Thionville, France, 57530
Hôpital Saint Eloi
Montpellier, France, 34295
Clinique Brétéché
Nantes, France, 44046
Hôpital Nord Laennec
Nantes, France, 44093
Nouvelles Cliniques Nantaises
Nantes, France, 44202
Hôpital Universitaire Caremeau
Nimes, France, 30029
Hôpital Lariboisière
Paris, France, 75010
Hôpital Cochin
Paris, France, 75014
Centre hospitalier Universitaire de Rouen
Rouen, France, 76000
Clinique IRIS Saint-Priest
Saint-Priest, France, 69800
Germany
Neurologische Klinik Universitätsklinikum
Würzburg, Josef-Schneider-Str. 11, Germany, 97080
Neurologische Klinik Klinikum rechts der Isar
Munchen, Germany, 81675
Sponsors and Collaborators
Air Liquide Santé International
AMS Advanced Medical Services GmbH
Investigators
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Study Chair: Didier Bouhassira, MD Hospital Ambroise Paré Paris

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Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT02957851     History of Changes
Other Study ID Numbers: ALMED-15-C2-054
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents