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Treatment will start with dose escalation in addition to Standard of Care (steroid therapy with or without additional therapies) .
At the conclusion of the dose escalation segment of the study, if the 300 mg Cannabidiol dose level/placebo is deemed safe for two weeks with Standard of care dose of steroids, patients will continue receiving this 300 mg dose/placebo for an additional period of 3 months. Weekly tapering off of steroids will then commence and will be carried out .
Three months after starting treatment with Cannabidiol an interim analysis to evaluate Cannabidiol's safety and efficacy will be carried out and treatment assignment group may be changed (according to response confirmation)
Individual patient Standard of Care (steroid therapy with or without additional therapies) will be administered in a stable fashion during the first weeks of the study in addition to increasing doses of Cannabidiol or placebo ( in a double blind manner. Dosage of Cannabidiol will start at 25 mg twice a day and will be increased every two days, if no side effects are observed, to 50 mg twice a day, 100 mg twice a day and finally to 150 mg twice a day Cannabidiol respectively. Treatment will be given with food. Identical placebo will be administered in the placebo arm. In stage 1,both patient and investigator will be blinded to treatment modalities.
At the conclusion of the dose escalation segment of the study, if the 300 mg Cannabidiol dose level/placebo is deemed safe for two weeks with Standard of care dose of steroids, patients will continue receiving this 300 mg dose/placebo for an additional period of 3 months. Weekly tapering off of steroids will then commence and will be carried out .
Three months after starting treatment with Cannabidiol an interim analysis to evaluate Cannabidiol's safety and efficacy will be carried out by an independent assessor not associated with the study .At the conclusion of this interim analysis, Cannabidiol Non-responders will be removed from the trial, and Placebo Non-responders will be switched over to Cannabidiol.
If a patient flares, then his/her code will be opened by the unblinded observer. If the subject has been administered placebo, then he/she will be crossed over to the Cannabidiol arm. If the subject has been administered Cannabidiol, then he/she will be restarted on Standard of care prednisone in addition to Cannabidiol or removed from study, depending on the severity of the flare-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental | 300 mg Cannabidiol (synthetic form) Olive Oil Solution, 5% |
|
| Placebo | Placebo Comparator | Olive Oil Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol , synthetic form | Drug | Cannabidiol ( synthetic form) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety and tolerability of up to 300 mg CBD/day measured by Adverse Events | significance of the difference in percent of subjects experienced any Adverse events, drug-related Adverse events and Serious Adverse events between the study groups | 12 month |
| Efficacy will be mesursed by precentegae of reduction in dose of steroids without flares | 50% reduction in dose of steroids without flares | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients without flares | Disease flare will be recorded during the study | 12 month |
| Percent of patients who did not demonstrate an increase in inflammatory activity | inflammatory activity scored will be measured during the study |
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Inclusion Criteria:
Exclusion Criteria:
Viral Hepatitis (HAV, HBV, HCV)
HIV
Serious psychiatric or psychological disorders
Active consumption of illicit drugs including cannabis or derivatives for at least 3 months prior to the study
Patients with short bowel syndrome, symptomatic stricture, abscess, recent history (within the previous 3 months) of abdominal surgery, nutrient absorbance problems
Patients whose disease is inaccessible by endoscopy
Patients with significant cardiac, respiratory or active malignance disease (except Basel Cell Carcinoma) comorbidities.
Any uncontrolled infection at time of registration
Renal comorbidity: eGFR < 30 mL/min/1.73 m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2)
Patient who is taking immunomodulatory medications for other indication
Women of child-bearing potential who intend to become pregnant or who are pregnant or breastfeeding
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Medical Center | Beersheba | Israel | ||||
| Meir Medical Center |
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Patients will be randomized at a 2:1 Cannabidiol:placebo ratio. After 3 month of treatment a blinded assessor will assess the patient response.
Cannabidiol Non-responders will be removed from the trial, and Placebo Non-responders will be switched over to Cannabidiol
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| Placebo |
| Drug |
Olive Oil Solution, 5% |
|
| 12 month |
| Kfar Saba |
| Israel |
| Shamir Medical Center | Tzrifin | Israel |
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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