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| Name | Class |
|---|---|
| Jazz Pharmaceuticals Research UK Limited | INDUSTRY |
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This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental | Cannabidiol solution 100 milligrams per milliliter (mg/mL) will be administered orally at a dose level of 5 mg/kg/day for 1 week, then increase to 10 mg/kg/day by the participant or their caregiver twice each day (morning and evening). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | Oral Cannabidiol solution 100 mg/mL |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Liver Fibrosis and Evaluable Fibrotic Changes as Determined and Assessed by an Independent Adjudication Committee | Screening, Day 365, Day 730, Day 1095, Day 1460, and Day 1825 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Aspartate Aminotransferase (AST) to Platelet Ratio Index | Baseline, Day 365, Day 730, Day 1095, Day 1460, and Day 1825 | |
| Change from Baseline in the Enhanced Liver Fibrosis Score | Baseline, Day 365, Day 730, Day 1095, Day 1460, and Day 1825 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Little Rock | Arkansas | 72758 | United States | ||
| Clinical Trial Site |
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| Change From Baseline in Fibrosis-4 | Baseline, Day 365, Day 730, Day 1095, Day 1460, and Day 1825 |
| Change From Baseline in FibroScan Scoring (FibroScan subset only) | Baseline, Day 365, Day 730, Day 1095, Day 1460, and Day 1825 |
| Number of Participants With Potential Drug-Induced Liver Injury (DILI) | Day 1, Day 365, Day 730, Day 1095, Day 1460, and Day 1825 |
| Number of Participants with Severe Treatment-emergent Adverse Events (TEAEs) | Day 1, Day 365, Day 730, Day 1095, Day 1460, and Day 1825 |
| Number of Participants With Clinically Significant Clinical Laboratory Findings | Day 1, Day 365, Day 730, Day 1095, Day 1460, and Day 1825 |
| Number of Participants With Clinically Significant Physical Examinations | Day 1, Day 365, Day 730, Day 1095, Day 1460, and Day 1825 |
| Downey |
| California |
| 90242 |
| United States |
| Clinical Trial Site | Long Beach | California | 90806 | United States |
| Clinical Trial Site | Sacramento | California | 95817 | United States |
| Clinical Trial Site | Miami | Florida | 33136 | United States |
| Clinical Trial Site | Miami | Florida | 33176 | United States |
| Clinical Trial Site | Orlando | Florida | 32806 | United States |
| Clinical Trial Site | Tampa | Florida | 33606 | United States |
| Clinical Trial Site | Augusta | Georgia | 30912 | United States |
| Clinical Trial Site | Wichita | Kansas | 67214 | United States |
| Clinical Trial Site | Lexington | Kentucky | 40504 | United States |
| Clinical Trial Site | Baltimore | Maryland | 21205 | United States |
| Clinical Trial Site | Boston | Massachusetts | 02114 | United States |
| Clinical Trial Site | New Brunswick | New Jersey | 08901 | United States |
| Clinical Trial Site | New York | New York | 10016 | United States |
| Clinical Trial Site | Charlotte | North Carolina | 28203 | United States |
| Clinical Trial Site | Durham | North Carolina | 27708 | United States |
| Clinical Trial Site | Cincinnati | Ohio | 45219 | United States |
| Clinical Trial Site | Oklahoma City | Oklahoma | 73104 | United States |
| Clinical Trial Site | Philadelphia | Pennsylvania | 19107 | United States |
| Clinical Trial Site | Charleston | South Carolina | 29425 | United States |
| Clinical Trial Site | Austin | Texas | 78758 | United States |
| Clinical Trial Site | Dallas | Texas | 75251 | United States |
| Clinical Trial Site | Houston | Texas | 77030 | United States |
| Clinical Trial Site | Round Rock | Texas | 78681 | United States |
| Clinical Trial Site | Winchester | Virginia | 22601 | United States |
| ID | Term |
|---|---|
| D065768 | Lennox Gastaut Syndrome |
| D004831 | Epilepsies, Myoclonic |
| D014402 | Tuberous Sclerosis |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D000073376 | Epileptic Syndromes |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004829 | Epilepsy, Generalized |
| D006222 | Hamartoma |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D065703 | Malformations of Cortical Development, Group I |
| D054220 | Malformations of Cortical Development |
| D009421 | Nervous System Malformations |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D000013 | Congenital Abnormalities |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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