EMONO for the Treatment of Peripheral Neuropathic Pain (ProtoTOP)

Air Liquide

Status and phase: Completed; Phase 2

Conditions: Neuralgia

Treatments: Drug: EMONO; Drug: Medical Air

Study type: Interventional

Funder types: Industry

Identifiers

NCT02957851

ALMED-15-C2-054

Details and patient eligibility

About

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

Enrollment: 287 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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287 participants in 2 patient groups, including a placebo group

Oxygen/Nitrogen (22%/78%)

Placebo Comparator group

Description:

Medical Air

Treatment:

Drug: Medical Air

Nitrous Oxide/Oxygen (50%/50%)

Active Comparator group

Description:

EMONO

Treatment:

Drug: EMONO