NCT02987114

A Study to Evaluate the Safety, Tolerability and Efficacy of Oral Administration of PTL101 (Cannabidiol) as an Adjunctive Treatment for Pediatric Intractable Epilepsy

A Phase II, Open-label, Single-center Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Oral Administration of PTL101 (Cannabidiol) as an Adjunctive Treatment for Pediatric Intractable Epilepsy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: PhytoTech Therapeutics, Ltd. · Industry
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety, tolerability and efficacy of oral administration of PTL101 (cannabidiol) for the treatment for pediatric intractable epilepsy. Study will include a 4-week observation period ,12 weeks of treatment and 2 weeks of follow up.

Detailed description

This is an open-label, single-center study recruiting approximately 15 male or female pediatric (ages 2-15, inclusive) patients with, intractable epilepsy, on stable doses of antiepileptic drugs (AEDs). The study comprised of the following period: 4 weeks observation period, followed by a 2-week dose titration period, 10-week maintenance treatment period, and a 2-week follow-up of which 1 week is a tapering-off period. Seizures will be recorded by the legal guardian/caregiver in seizure diaries throughout the first 16 weeks of the study.

Conditions

• Epilepsy Intractable

Interventions

Type	Name	Description
DRUG	PLT101	PTL 101 (Cannabidiol, CBD) Two piece hard capsules filled with seamless gelatin matrix green beads containing CBD (50 or 100 mg CBD per capsule) The beads should be administered following a meal, mixed with food

Timeline

• Start date: 2017-02-13
• Primary completion: 2018-06-28
• Completion: 2018-06-28
• First posted: 2016-12-08
• Last updated: 2018-09-06

Locations

1 site across 1 country: Israel