A Study of GWP42006 in People With Focal Seizures - Part B
A Study of GWP42006 in People With Focal Seizures - Part B
To investigate the potential antiepileptic effects of GWP42006 as add-on therapy in subjects
 with inadequately controlled focal seizures.
This is a double blind, randomized, placebo controlled, two-part study. Part B only will be
 described in this record.

 Subjects who satisfy all inclusion and none of the exclusion criteria will enter a four-week
 baseline period, followed by a two-week dose escalation period (400 mg twice daily for one
 week, then 600 mg twice daily for one week), a six-week stable treatment period (800 mg twice
 daily) and a 12-day taper period. Subjects will be required to attend eight study visits. A
 follow-up phone call will take place four weeks after last dose.

 Subjects will be randomized to receive in a 1:1 ratio, GWP42006 or placebo. Subjects will be
 required to record a daily diary with information about their seizures, investigational
 medicinal product (IMP) and concomitant antiepileptic drug (AED) administration.
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.