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Clinical Trials/EUCTR2019-001633-14-IT
EUCTR2019-001633-14-IT
Active, Not Recruiting
Phase 1

A single-centre, open-label pilot study to assess the efficacy and safety of CBD oral solution as an adjunctive treatment for pediatric subjects with Developmental and Epileptic Encephalopathy - CBD_DEE

IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA0 sites20 target enrollmentMay 24, 2021
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ConditionsDevelopmental and Epileptic Encephalopathy (DEE)MedDRA version: 20.0Level: PTClassification code 10077380Term: Epileptic encephalopathySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsEpidiolex

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Developmental and Epileptic Encephalopathy (DEE)
Sponsor
IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
Enrollment
20
Status
Active, Not Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 24, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

Not specified

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