Adjunctive cannabidiol therapy in patients with CDKL5 deficiency disorder. Interventional drug study on efficacy and safety with focus on seizure effects
- Conditions
- patients with CDKL5MedDRA version: 20.0Level: PTClassification code 10015039Term: Epilepsy congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-001959-13-IT
- Lead Sponsor
- FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 15
•Male and female patients aged =1 year and = 30 years
•Patients with a confirmed diagnosis of CDKL5 deficiency disorder
•Patients with = 4 motor seizures/month in the last 6 months at baseline
•Patients with 12-week baseline seizure frequency data available either from seizure diaries or medical records
•Based on the physician's clinical judgment, seizures not adequately controlled with the current treatment
Are the trial subjects under 18? yes
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 3
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Patients on an investigational drug or device within 30 days prior to the initiation of the present study
•Patients on an artisanal cannabis derivative treatment
•Patients with severe hepatic impairment
•Patients contraindicated for cannabidiol use (according to SmPC), including suspected sesame seed allergy or history of hypersensitivity to cannabidiol or any ingredients in the product
•Pregnant or lactating females
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