A pilot study to assess the efficacy and safety of CBD oral solution in addition to standard treatment for pediatric subjects with Developmental and Epileptic Encephalopathy

Phase 1

• Conditions: Developmental and Epileptic Encephalopathy (DEE); MedDRA version: 20.0Level: PTClassification code 10077380Term: Epileptic encephalopathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-001633-14-IT
• Lead Sponsor: IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

oMale or female;
oAged between 2 and 7 years;
oA documented history of DEE [7];
oCurrently taking at least 1 other AED between one and four AEDs, with a stable antiseizure treatment for the previous 4 weeks (including ketogenic diet and vagus nerve stimulation);
oInadequately seizure control with 2 or more current or prior AEDs;
oWritten informed consent provided by the participant and/or parent(s)/caregiver(s).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

oClinically significant unstable medical or psychiatric conditions that may place patient’s safety at risk;
oClinically significant liver disease or serum aminotransferase (ALT or AST) >3 times the upper limit of the normal range or total bilirubin >2 times the upper limit of the normal range or international normalized ratio (INR) >1.5;
oKnown or suspected intolerance or hypersensitivity to cannabinoids or any of the excipients of the medicinal product such as sesame oil;
oCurrent use of ACTH or other systemic steroids;
oCurrent use (or use in the previous 2 months) of medicinal cannabis, or synthetic cannabinoid-based medications;
oInadequate supervision by parent(s)/caregiver(s) in the judgment of investigators
oStable felbamate dosing = 1 year;
oSubjects who have been part of a clinical trial involving another investigational product in the previous six months;
oSubjects with severe renal impairment: estimated glomerular filtration rate (eGFR) calculated as crCL < 30 ml/min, according to Schwartz equation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified