A study of cannabidiol (GWP42003-P, CBD) in patients with tuberous sclerosis complex who experience seizures.
- Conditions
- Tuberous Sclerosis Complex (TSC)MedDRA version: 19.0Level: PTClassification code 10045138Term: Tuberous sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2015-002154-12-ES
- Lead Sponsor
- GW Research Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 192
• Patient is male or female aged between one and 65 years
inclusive.
• Patient and/or parent(s)/legal representative is willing and able
to give informed consent/assent for participation in the study.
• Well-documented history of epilepsy, with compatible
electroencephalogram (EEG) and clinical history.
• Clinical diagnosis of TSC according to criteria agreed by the
2012 International Tuberous Sclerosis Complex Consensus
Conference.
• All medications or interventions for epilepsy (including
ketogenic diet and any neurostimulation devices for epilepsy)
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 criterion:
• Completed at least 90% of calls to IVRS during the first
28 days of the baseline period (a minimum of 25 completed calls).
Are the trial subjects under 18? yes
Number of subjects for this age range: 84
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Patient has a history of pseudo-seizures.
• Patient has undergone general anesthetic in the four weeks
prior to screening or randomization.
• Patient has undergone surgery for epilepsy in the six months
prior to screening.
• Patient is being considered for epilepsy surgery or any
procedure involving general anesthesia during the blinded
phase of the study.
• Patient is taking felbamate, and they have been taking it for
less than one year prior to screening.
• Patient is taking an oral (mTOR) inhibitor.
• 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 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 tumor growth which, in the opinion of the
Investigator, could affect the primary endpoint.
• Patient is female and of child bearing potential, or is male
whose partner is of child bearing potential, unless willing to
ensure that they or their partner use a highly effective method
of birth control (e.g., hormonal contraceptives, intrauterine
devices/hormone-releasing systems, bilateral tubal occlusion,
vasectomized partner, sexual abstinence) during the study and
for three months thereafter.
• Female patient who is pregnant (positive pregnancy test),
lactating or planning pregnancy during the course of the study
and for three months thereafter.
• Patient has received an IMP within the 12 weeks prior to the
screening visit.
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