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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
162
Unnamed facility
Havířov, Czechia
Unnamed facility
Hradec Králové, Czechia
Unnamed facility
Percentage change from baseline to the end of treatment in focal seizure frequency in subjects taking GWP42006 compared to placebo.
Time frame: Day -28 to Day 57
Number of subjects considered treatment responders.
Time frame: Day -28 to Day 57
Change from baseline in seizure subtypes frequency.
Time frame: Day -28 to Day 57
Change from baseline in composite seizure score.
Time frame: Day -28 to Day 57
Change from baseline in the number of focal seizure free days.
Time frame: Day -28 to Day 57
Change from baseline in the usage of rescue medication.
Time frame: Day -28 to Day 57
Subject Global Impression of Change (SGIC).
Time frame: Day 57
Physician Global Impression of Change (PGIC) at the end of treatment.
Time frame: Day 57
The incidence of adverse events as a measure of subject safety.
Time frame: Day -28 to Day 96
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Prague, Czechia
Unnamed facility
Rychnov nad Kněžnou, Czechia
Unnamed facility
Budapest, Hungary
Unnamed facility
Esztergom, Hungary
Unnamed facility
Hódmezővásárhely, Hungary
Unnamed facility
Kecskemét, Hungary
Unnamed facility
Pécs, Hungary
Unnamed facility
Szombathely, Hungary
...and 16 more locations