Transvamix (10% THC / 5% CBD) to treat chronic pain in Epidermolysis Bullosa: An explorative randomized, placebo-controlled and double-blind intervention crossover study

niversity Medical Center of Groningen0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•Clinical diagnosis, supplemented by genetic analysis, immunofluorescent diagnostics or electron microscopy of congenital epidermolysis bullosa (EB). Including the subtypes recessive dystrophic EB, dominant dystrophic EB, junctional EB and EB simplex.
•-At least 16 years of age from the date of onset of participation.
•-Can read and write in the Dutch language.
•-Mentally competent and legally able to appreciate informed consent.
•-Reporting an average pain or pruritus mean score =4 on NRS (0-10) averaged throughout the previous week at one of the following times of day: morning, afternoon or evening.
•-Negative COVID-19 testing will be required prior to participation

•-Patients enrolled in other clinical trials that do not allow for a deviation in treatment.
•-Have experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or have had a cardiac disorder that, in the opinion of the investigator would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction.
•-Patients with known psychotic disorder (including the use of antipsychotic medications), or a history of suicidal ideation.
•-Female patients of child-bearing potential and male participants whose partner was of child-bearing potential, unless willing to ensure that they or their partner used effective contraception.
•-Patients who have had significantly impaired renal or hepatic function in the last 12 months.
•-The patient is currently using or has used cannabis or cannabinoid-based medications within 30 days of study entry and was unwilling to abstain for the duration of the study.
•-Patients unwilling or unable to refrain from driving road vehicles and/or using potentially dangerous machinery where sufficient concentration is necessary.
•-Patients unable to stay within the Netherlands for the duration of the study period.
•-History of addiction and/or hospital admission due to addiction to recreational or pharmaceutical drugs.
•-Patients with contradictions for MRI determined through the MRI safety form

发起方

niversity Medical Center of Groningen