Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02957851
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2016-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EMONO for the Treatment of Peripheral Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000388', 'term': 'Air'}, {'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D009584', 'term': 'Nitrogen'}, {'id': 'D009609', 'term': 'Nitrous Oxide'}], 'ancestors': [{'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-20', 'studyFirstSubmitDate': '2016-10-20', 'studyFirstSubmitQcDate': '2016-11-04', 'lastUpdatePostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '7 days after the last administration of treatment', 'description': 'Numeric Rating Scale (NRS)'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '28 days after the last administration of treatment', 'description': 'Numeric Rating Scale (NRS)'}, {'measure': 'Pain characteristic', 'timeFrame': '28 days after the last administration of treatment', 'description': 'Neuropathic Pain Symptom Inventory (NPSI)'}, {'measure': 'Quality of life questionnaire', 'timeFrame': '28 days after the last administration of treatment', 'description': 'Medical Outcome Study Short Form (SF-12)'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'through study duration, up to 31 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neuralgia']}, 'referencesModule': {'references': [{'pmid': '35050957', 'type': 'DERIVED', '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.'}, {'pmid': '33044394', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Neuropathic pain lasting for more than 3 months but less than 10 years\n* Definite or probable peripheral neuropathy\n\nExclusion Criteria:\n\n* legal incapacity\n* patient with another concomitant chronic pain\n* ongoing major depression\n* Chemotherapy-induced peripheral neuropathic pain'}, 'identificationModule': {'nctId': 'NCT02957851', 'acronym': 'ProtoTOP', 'briefTitle': 'EMONO for the Treatment of Peripheral Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Air Liquide Santé International'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ALMED-15-C2-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Oxygen/Nitrogen (22%/78%)', 'description': 'Medical Air', 'interventionNames': ['Drug: Medical Air']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nitrous Oxide/Oxygen (50%/50%)', 'description': 'EMONO', 'interventionNames': ['Drug: EMONO']}], 'interventions': [{'name': 'Medical Air', 'type': 'DRUG', 'otherNames': ['Oxygen/Nitrogen'], 'armGroupLabels': ['Oxygen/Nitrogen (22%/78%)']}, {'name': 'EMONO', 'type': 'DRUG', 'otherNames': ['Nitrous Oxide/Oxygen'], 'armGroupLabels': ['Nitrous Oxide/Oxygen (50%/50%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38700', 'city': 'Grenoble', 'state': 'La Tronche', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '14401', 'city': 'Bayeux', 'country': 'France', 'facility': 'Centre Hospitalier de Bayeux', 'geoPoint': {'lat': 49.27732, 'lon': -0.7039}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Hôpital Ambroise Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Hopital Neurologique Weirthermer', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Gabriel Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '93350', 'city': 'Le Bourget', 'country': 'France', 'facility': 'Clinique du Bourget', 'geoPoint': {'lat': 48.93405, 'lon': 2.43584}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '57530', 'city': 'Metz-Thionville', 'country': 'France', 'facility': 'Centre Hospitalier Régional de Metz-Thionville'}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44046', 'city': 'Nantes', 'country': 'France', 'facility': 'Clinique Brétéché', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Hôpital Nord Laennec', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44202', 'city': 'Nantes', 'country': 'France', 'facility': 'Nouvelles Cliniques Nantaises', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Hôpital Universitaire Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre hospitalier Universitaire de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '69800', 'city': 'Saint-Priest', 'country': 'France', 'facility': 'Clinique IRIS Saint-Priest', 'geoPoint': {'lat': 45.69651, 'lon': 4.94385}}, {'zip': '97080', 'city': 'Würzburg', 'state': 'Josef-Schneider-Str. 11', 'country': 'Germany', 'facility': 'Neurologische Klinik Universitätsklinikum', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Neurologische Klinik Klinikum rechts der Isar', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Didier Bouhassira, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Ambroise Paré Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Liquide Santé International', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AMS Advanced Medical Services GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}