JPRN-jRCT2031220041
Recruiting
Phase 3
An open-label study to investigate the safety and efficacy of cannabidiol oral solution (GWP42003-P) in Japanese children and adults as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex
Yamamoto Tomoyuki0 sites84 target enrollmentApril 25, 2022
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- ennox-Gastaut syndrome, Dravet syndrome, tuberous sclerosis complex
- Sponsor
- Yamamoto Tomoyuki
- Enrollment
- 84
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Participant must be Japanese.
- •2\.Participan must fulfill conditions\-specific criteria for Lennox\-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC).
- •3\.Male or female \>\= 1 to \<\= 65 years of age at time of signing the informed consent form.
- •4\.Taking 1 or more antiepileptic drugs (AEDs) at a stable dose for at least 4 weeks prior to screening.
- •5\.Complete at least 25 days of seizure diary entries during the 28 days of the baseline period.
Exclusion Criteria
- •1\. Etiology of seizures is a progressive neurologic disease. Participants with TSC will not be excluded from study participation unless there is a progressive tumor.
- •2\. Has had an anoxic episode requiring resuscitation within 6 months of screening.
- •3\. Has clinically significant medical conditions other than epilepsy.
- •4\. Has undergone surgery for epilepsy in the 26 weeks prior to screening.
- •5\. Has clinically significant abnormal laboratory values, in the investigator's opinion, at screening or enrollment.
- •6\. Has a history of pseudo\-seizures.
- •7\. Has clinically significant unstable medical conditions other than epilepsy.
- •8\. Any history of suicidal behaviour or any suicidal ideation of type 4 or 5 on the Columbia\-Suicide Severity Rating Scale (C\-SSRS)/Children's C\-SSRS in the last month, or at screening. This criterion applies only to participants \>\= 4 years of age.
- •9\. Known or suspected hypersensitivity to cannabinoids, or any of the excipients of study intervention, such as sesame oil.
- •10\. In the opinion of the investigator, the participant has clinically significant abnormalities in the 12\-lead electrocardiogram (ECG) measured at screening or enrollment, or any concurrent cardiovascular conditions, which will interfere with the ability to read their ECGs.
Outcomes
Primary Outcomes
Not specified
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