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

NCT04439955 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CBD

300 mg CBD

Sponsors & Collaborators

  • Stero Biotechs Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04439955 on ClinicalTrials.gov