EMONO for the Treatment of Peripheral Neuropathic Pain

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Liquide Santé International
• Collaborators: Advanced Medical Services GmBh - AMS; AMS Advanced Medical Services GmbH
• Treatments: Nitrous Oxide

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