drugset / Trial / NCT04439955

Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients

NCT04439955 ↗

Phase 2 Completed 15 enrolled Stero Biotechs Ltd.
NaSingle-groupOpen-labelTreatment

Summary

Each patient will commence the study with a one month run-in period in which he/she will be administered individual patient Standard of Care :anti-histamines and steroids as needed plus placebo (olive oil). After the run-in period, doses of CBD will be incresed during the first six weeks of the study. At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines, patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional follow-up period of three month. Each patient will serve as his/her own control.

Timeline

Start
2020-02-01
Primary completion
2021-07-30
Completion
2021-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 300 mg —

Indications