Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) for the Treatment of Peripheral Neuropathic Pain: a Randomised, International, Multicentre, Placebo-Controlled, Phenotype-stratified Phase IIa Study

Air Liquide Santé International0 个研究点目标入组 287 人开始时间: 2016年7月22日最近更新: 2019年11月25日

试验速览

暂无简介。

•-Male or female patient aged 18 years or older
•-Definite or probable peripheral neuropathy confirmed by DN4 (score = 4) and NeuPSIG criteria (definite” or probable” levels) (see Appendix 2 and 3)
•-Neuropathic pain lasting for more than 3 months but less than 10 years
•-Pain intensity = 4 but = 9 as assessed on the 11-point NRS (Numeric Rating Scale)
•-Stable analgesic medications since at least 4 weeks prior the Selection visit V0
•-Peripheral neuropathy with at least one of the following aetiologies :
•Post-traumatic or post-surgical nerve injury
•Polyneuropathy including diabetic neuropathy
•Post-herpetic neuralgia
•-Patient willing and able to complete the requirements of this study
•-Written informed consent signed and dated by the patient after full explanation of the study prior to any study related procedures
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 250
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Legal incapacity or limited legal capacity
•-Chronic pain with mixed mechanisms, including inflammatory process such as radiculopathy
•-Patient with another co-located or not distinct concomitant chronic pain
•-Ongoing major depression
•-Patient with psychiatric disorders (schizophrenia, bipolar disorder...
•-Patient with drug addiction
•-Chemotherapy-induced peripheral neuropathic pain
•-Patient with ongoing litigation
•-Pregnancy or lactation
•-Severe terminal illness
•-Anticipated difficulties for administration of inhaled gas by mask (facial deformation,... that would make mask administration of inhaled gases inefficient)
•-Risk of need for high inhaled oxygen concentrations
•-Chronic respiratory failure requiring regular oxygen therapy
•-Ketamine administered within 4 weeks before selection
•-Any complementary medicine treatment (including hypnosis sessions) not stable within 4 weeks before selection
•-Participation in a drug or device trial within the previous 30 days
•-Known contraindication to administration of Nitrous Oxide/Oxygen 50%/50% (EMONO) including documented and untreated vitamin B12 (serum level) or folic acid (serum and red blood cell levels) deficiency

发起方

Air Liquide Santé International