EUCTR2014-002940-42-ES
Active, not recruiting
Phase 1
A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in children and adults.
GW Research Ltd0 sites120 target enrollmentDecember 16, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ennox-Gastaut syndrome (LGS)
- Sponsor
- GW Research Ltd
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? Patient and/or parent(s)/legal representative must be willing and able to give informed assent/consent for participation in the study.
- •? Patient and their caregiver must be willing and able (in the investigator?s opinion) to comply with all study requirements.
- •? Patient must be male or female aged between two and 55 years (inclusive).
- •? Patient must have a documented history of LGS. This includes written documentation of having met electroencephalogram (EEG) diagnostic criteria during the patient?s history and evidence of at least one type of generalized seizure, including drop seizures (atonic, tonic, tonic\-clonic, clonic or myoclonic) for at least six months.
- •? Patients who have a history of slow (\<2\.5 Hz) spike\-and\-wave pattern in an EEG prior to the enrollment into the baseline period.
- •? Patients must have at least two drop seizures each week during the 28\-day baseline period.
- •? Patients should be refractory; that is having documented failures on more than one antiepileptic drug (AED).
- •? Patient must be taking one or more AEDs at a dose which has been stable for at least four weeks prior to screening.
- •? All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation \[VNS]) must have been stable for four weeks prior to screening and patient is willing to maintain a stable regimen throughout the study. The ketogenic diet and VNS treatments are not accounted as an AED.
- •? Patient and/or parent(s)/legal representative is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.
Exclusion Criteria
- •? Etiology of patient's seizures is a progressive neurologic disease. Patients with tuberous sclerosis will not be excluded from study participation, unless there is a progressive tumor.
- •? Patient has had an anoxic episode requiring resuscitation within six months of screening.
- •? Patient has clinically significant unstable medical conditions other than epilepsy.
- •? Patient has had clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or randomization, other than epilepsy.
- •? Patient has clinically significant abnormal laboratory values, in the investigator?s opinion, at screening or randomization.
- •? Patient has clinically relevant abnormalities in the ECG measured at screening or randomization.
- •? Patient has any concurrent cardiovascular conditions, which will, in the investigators opinion, interfere with the ability to assess their ECGs.
- •? Patient has a history or presence of alcohol or substance abuse within the last two years prior to the study 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 synthetic cannabinoid based medications (including Sativex®) within the three months prior to study entry.
- •? Patient is unwilling to abstain from using recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex) during the study.
Outcomes
Primary Outcomes
Not specified
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Unknown
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