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Completed

NCT Number: NCT02957851

EMONO for the Treatment of Peripheral Neuropathic Pain

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

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Key information

Conditions

Neuralgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Grenoble, Grenoble, La Tronche, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Air

Drug

Other names: Oxygen/Nitrogen

EMONO

Drug

Other names: Nitrous Oxide/Oxygen

Primary outcomes

  1. Pain intensity

    Time frame: 7 days after the last administration of treatment

    Numeric Rating Scale (NRS)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Air Liquide Santé International

Industry

Collaborators

  • AMS Advanced Medical Services GmbH

Registry information

Official study 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

Acronym: ProtoTOP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2016
Registry last updated
Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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