NeuralgiaPhase 2ProtoTOPNCT02957851
EMONO for the Treatment of Peripheral Neuropathic Pain
A Phase 2 study testing Medical Air and EMONO in people with Neuralgia, run by Air Liquide Santé International at 22 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia
- What is being tested?
- Medical Air and EMONO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Nov 2016to Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- legal incapacity
- patient with another concomitant chronic pain
- ongoing major depression
- Chemotherapy-induced peripheral neuropathic pain
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
France20 sites
Centre Hospitalier de Bayeux
Bayeux, 14401
Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz
Besançon, 25030
Hôpital Pellegrin
Bordeaux, 33000
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Hopital Neurologique Weirthermer
Bron, 69677
Centre Hospitalier Universitaire Gabriel Montpied
Clermont-Ferrand, 63003
CHU de Grenoble
Grenoble, La Tronche, 38700
Clinique du Bourget
Le Bourget, 93350
Centre Hospitalier Universitaire Dupuytren
Limoges, 87042
CHU la Timone
Marseille, 13385
Centre Hospitalier Régional de Metz-Thionville
Metz-Thionville, 57530
Hôpital Saint Eloi
Montpellier, 34295
Clinique Brétéché
Nantes, 44046
Hôpital Nord Laennec
Nantes, 44093
Nouvelles Cliniques Nantaises
Nantes, 44202
Hôpital Universitaire Caremeau
Nîmes, 30029
Hôpital Lariboisière
Paris, 75010
Hôpital Cochin
Paris, 75014
Centre hospitalier Universitaire de Rouen
Rouen, 76000
Clinique IRIS Saint-Priest
Saint-Priest, 69800
Germany2 sites
Neurologische Klinik Klinikum rechts der Isar
München, 81675
Neurologische Klinik Universitätsklinikum
Würzburg, Josef-Schneider-Str. 11, 97080
About this study
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
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
- Conditions
- Neuralgia
- Being tested
- Medical Air, EMONO
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical AirDrug
Also called Oxygen/Nitrogen
EMONODrug
Also called Nitrous Oxide/Oxygen
| Study group | Role | What they receive |
|---|---|---|
| Oxygen/Nitrogen (22%/78%) | Placebo comparator | Medical Air Receives: Drug: Medical Air |
| Nitrous Oxide/Oxygen (50%/50%) | Active comparator | EMONO Receives: Drug: EMONO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Numeric Rating Scale (NRS)
Measured: 7 days after the last administration of treatment
Secondary outcomes (4)
Pain intensity
Numeric Rating Scale (NRS)
Measured: 28 days after the last administration of treatment
Pain characteristic
Neuropathic Pain Symptom Inventory (NPSI)
Measured: 28 days after the last administration of treatment
Quality of life questionnaire
Medical Outcome Study Short Form (SF-12)
Measured: 28 days after the last administration of treatment
Number of patients with adverse events
Measured: through study duration, up to 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AMS Advanced Medical Services GmbH
- Responsible party
- Sponsor
- Investigators
- Didier Bouhassira, MD, Study chair, Hospital Ambroise Paré Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957851
- Sponsor's protocol ID
- ALMED-15-C2-054
- Acronym
- ProtoTOP
- Status last verified
- Sep 2018
- First submitted
- 20 Oct 2016
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35050957Bouhassira 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.
PubMed 33044394
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02957851
- Acronym / sponsor ID
- ProtoTOP / ALMED-15-C2-054
- Conditions
- Neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- AMS Advanced Medical Services GmbH
- Study start
- Nov 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen/Nitrogen (22%/78%) | Placebo comparator | Drug: Medical AirMedical Air |
| Nitrous Oxide/Oxygen (50%/50%) | Active comparator | Drug: EMONOEMONO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- legal incapacity
- patient with another concomitant chronic pain
- ongoing major depression
- Chemotherapy-induced peripheral neuropathic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical AirAlso: Oxygen/Nitrogen | Drug | Oxygen/Nitrogen (22%/78%) |
| EMONOAlso: Nitrous Oxide/Oxygen | Drug | Nitrous Oxide/Oxygen (50%/50%) |
Primary outcome
Pain intensity
Time frame: 7 days after the last administration of treatment
Numeric Rating Scale (NRS)
4 secondary outcomes
Pain intensity
Time frame: 28 days after the last administration of treatment
Pain characteristic
Time frame: 28 days after the last administration of treatment
Quality of life questionnaire
Time frame: 28 days after the last administration of treatment
Number of patients with adverse events
Time frame: through study duration, up to 31 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Derived from this study: PubMed 35050957Bouhassira 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.
- Derived from this study: PubMed 33044394Bouhassira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Bouhassira, MD study chair
Hospital Ambroise Paré Paris
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medical Air and EMONO in people with Neuralgia, run by Air Liquide Santé International at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 7 days after the last administration of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02957851, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.