Clinical trial NCT02365610 (phase 2, status: completed)
Conditions: epilepsy, focal seizures
ICD codes: G40.803, G40.804, G40.911, G40.919, G40.B11, G40.B19, G40.801
Drugs: gwp42006, placebo control
SMILES: [H][C@]1(CCC(C)=C[C@H]1C1=C(O)C=C(CCC)C=C1O)C(C)=C, CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)C=C1
Eligibility criteria:

        For inclusion in Part B of the study patients must fulfil ALL of the following criteria:

          -  Male or female aged between 18 and 65 years, inclusive.

          -  Well-documented history of focal epilepsy, compatible electroencephalogram and
             clinical history.

          -  Documented computerized tomography / magnetic resonance imaging that shows no
             progressive neurologic abnormality.

          -  Has focal seizures despite prior treatment with at least two AEDs (whether as
             monotherapies or in combination).

          -  Currently treated with one to three AEDs.

          -  All medications or interventions for epilepsy (including ketogenic diet) must have
             been stable for one month prior to screening and the subject is willing to maintain a
             stable regimen throughout the study.

          -  Subject is willing to keep any factors expected to affect seizures stable (such as the
             level of alcohol consumption and smoking).

        The patient may not enter Part B of the study if ANY of the following apply:

          -  Time of onset of focal epilepsy treatment is less than two years prior to enrolment.

          -  Patient has seizures that are not of focal onset.

          -  Patient only has focal seizures without impairment of consciousness or awareness and
             without an observable motor component (even if autonomic component is present).

          -  Episode(s) of status epilepticus during one year prior to screening.

          -  History of pseudo-seizures.

          -  Vagus Nerve Stimulation, Deep Brain Stimulation, Responsive Neurostimulator System or
             other epilepsy neurostimulation device have been implanted or activated less than one
             year prior to screening, and/or stimulation parameters have been stable for less than
             one month, and/or battery life of unit not anticipated to extend for duration of
             trial.

          -  Had epilepsy surgery within one year of screening.

          -  Subject has clinically significant unstable medical conditions other than epilepsy.

          -  Subject has an illness in the four weeks prior to screening or randomization, other
             than epilepsy, which in the opinion of the investigator would affect seizure
             frequency.

          -  Subject has significantly impaired hepatic function at Visit 1.

          -  Active suicidal plan/intent in the past six months, or a history of suicide attempt in
             the last two years, or more than one lifetime suicide attempt .

          -  Subject is currently using or has in the past used recreational or medicinal cannabis,
             or cannabinoid based medications within the three months prior to screening and is
             unwilling to abstain for the duration for the study.

          -  Subject has taken St John's Wort in the last two weeks and/or is unwilling to abstain
             throughout the study.

          -  Subject has consumed grapefruit or grapefruit juice three days prior to randomization
             and/or unwilling to abstain in the three days prior to Visits B2 and B7.

          -  Any known or suspected hypersensitivity to cannabinoids, sesame oil or any of the
             excipients of the IMP(s).

          -  Subjects who have received an IMP within the 12 weeks prior to the screening visit.