A study of GWP42006 in people with focal seizures

Phase 1

Conditions: Epilepsy
MedDRA version: 20.0Level: LLTClassification code 10016843Term: Focal seizuresSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-002594-11-CZ

Lead Sponsor: GW Research Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 170

Inclusion Criteria

• Patient must be willing and able to give informed consent for participation in the study.
• Male or female aged between 18 and 65 years, inclusive.
• Well-documented history of focal epilepsy, with focal seizures as the primary seizure type, compatible electroencephalogram and clinical history.
• Documented CT/MRI that shows no progressive neurologic abnormality.
• Has focal seizures despite prior treatment with at least two AEDs (whether as monotherapies or in combination).
• Patient is willing to keep any factors expected to affect seizures stable (such as the level of alcohol consumption and smoking).
• Patient is able (in the investigators opinion) and willing to comply with all study requirements (including accurate diary completion).
• Patient is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.

Part A only
• Currently treated with one to three AEDs as follows:
Group 1 - including Carbamazepine, Phenobarbital, Primidone or Phenytoin and excluding Valproic Acid (VPA).
Group 2 - including VPA and excluding Carbamazepine, Phenobarbital, Primidone and Phenytoin.
Group 3 - excluding VPA, Carbamazepine, Phenobarbital, Primidone and Phenytoin.
• All medications or interventions for epilepsy (including ketogenic diet and any neurostimulation devices for epilepsy) must have been stable for two weeks prior to screening and the patient is willing to maintain a stable regimen throughout the study.

Part B only
• 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 patient is willing to maintain a stable regimen throughout the study.
• At the end of the baseline period patients must also meet the following criteria:
- Complied with diary completion, having no more than three missed diary entries during baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 166
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

• Time of onset of epilepsy treatment is less than two years prior to enrolment.
• Episode(s) of status epilepticus during one year prior to screening.
• History of pseudo-seizures.
• Patient has clinically significant unstable medical conditions other than epilepsy.
• Patient 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.
• Patient has, in the investigator’s opinion, clinically significantly abnormal laboratory values.
• In the opinion of the investigator the patient has clinically significant abnormalities in the 12-lead electrocardiogram (ECG) measured at screening or randomization or any concurrent cardiovascular conditions, which will interfere with the ability to read their ECGs.
• 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.
• Patient has a history or presence of alcohol or substance abuse within the two years prior to screening or daily consumption of five or more alcohol-containing beverages.
• Patient 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.
• Patient has taken St John’s Wort in the two weeks prior to screening and/or is unwilling to abstain throughout the study.
• Any known or suspected hypersensitivity to cannabinoids, sesame oil or any of the excipients of the IMP(s).
• Female patients of child bearing potential and male patients whose partner is of child bearing potential, unless willing to ensure that they and/or their partner use a highly effective method of contraception.
• Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
• Patients who have received an IMP within the 12 weeks prior to the screening visit.
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or the patient’s ability to participate in the study.
• Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study.
• Unwilling to abstain from donation of blood during the study.
• Travel outside the country of residence planned during the study.
• Patients previously randomized into this study.
• Patient has consumed grapefruit or grapefruit juice three days prior to randomization and/or unwilling to abstain in the three days prior to PK sampling visits.

Part A only
•Patient has significantly impaired hepatic function at Visit 1 (ALT >5 x ULN or TBL >2 x ULN) OR the ALT or AST >3 x ULN and TBL >2 x ULN (or INR >1.5).

Part B only
•Patient has significantly impaired hepatic function at Visit 1 defined as any of the following:
- ALT or AST >5 × ULN.
- ALT or AST >3 × ULN and TBL >2 × ULN.
-ALT or AST >3 × ULN with the presence of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%).
• 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/

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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