A Study to Evaluate the Safety, Tolerability and Efficacy of Oral Administration of PTL101 (Cannabidiol) as an Adjunctive Treatment for Pediatric Intractable Epilepsy
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|ClinicalTrials.gov Identifier: NCT02987114|
Recruitment Status : Completed
First Posted : December 8, 2016
Last Update Posted : September 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Intractable||Drug: PLT101||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 13, 2017|
|Actual Primary Completion Date :||June 28, 2018|
|Actual Study Completion Date :||June 28, 2018|
PTL101 capsules (50 or 100 mg CBD per capsule) up to 25 mg/kg/day or up to 450 mg/day, the lower of the two. Twice daily (morning and evening).
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
- Incidence of study treatment related adverse events (AEs) [ Time Frame: 12 weeks of treatment + 2 weeks follow up ]
- Percent change in mean countable monthly seizure frequency [ Time Frame: 12 week treatment period ]
- Incidence of all adverse events (AEs) [ Time Frame: 12 weeks of treatment + 2 weeks follow up ]
- assessment of Caregiver Global Impression of Improvement using a 5-point rating scale [ Time Frame: after 5 weeks of maintenance dose and at end of treatment ]
- assessment of Caregiver Global Impression of Seizure Severity using a 5-point rating scale [ Time Frame: after 5 weeks of maintenance dose and at end of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987114
|Pediatric Epilepsy department- Souraskey Medical center|
|Tel Aviv, Israel|