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Eligibility: d25f1eef738065d149cfda5131ce9379 [RDF]

Label d25f1eef738065d149cfda5131ce9379
Slug d25f1eef738065d149cfda5131ce9379
Criteria Key Inclusion Criteria: - Participant must have epilepsy, as determined by the investigator, and be taking clobazam (CLB). - Participant must have a documented magnetic resonance imaging/computerized tomography of the brain ruling out a progressive neurologic condition. - Participant must be taking CLB and no more than 2 other antiepileptic drugs (AEDs) during the course of the trial. Key Exclusion Criteria: - Patient has clinically significant unstable medical conditions other than epilepsy. - Participants on CLB at doses above 20 mg per day. - Participants taking CLB intermittently as rescue medication. - 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 or at the screening visit of the blinded phase of the trial. - Participant has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or enrollment in the blinded phase of the trial, other than epilepsy. - 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.
Maximum age 55 Years
Healthy volunteers No
Study pop
Minimum age 18 Years
Gender Both
Sampling method
Provenances http://clinicaltrials.gov/show/NCT02564952?displayxml=true
Similars None
Interlinks None