An Open-label Extension Trial to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy

Launched by JAZZ PHARMACEUTICALS · Nov 16, 2015

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• • Note: Participants who enroll in France or Sweden must be aged 18-55 years.
• Key Inclusion Criteria:
• • Participant must have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition.
• Key Exclusion Criteria:
• • Participant has clinically significant unstable medical conditions other than epilepsy.
• • Participant has a history of symptoms related to a drop in blood pressure due to postural changes (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope).
• • Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month.
• • Participant is currently using felbamate and has been taking it for less than 12 months prior to screening visit of the blinded phase of the trial.
• • Participant is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to trial entry.
• • Participant has any known or suspected history of any drug abuse or addiction.
• • Participant is unwilling to abstain from recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex) for the duration for the trial.
• • Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP), e.g., sesame oil.