Novel CBD gelatin bead formulation reduced seizures by 82% in children with treatment-resistant epilepsy
PTL-101, an oral CBD formulation designed for better absorption, reduced median seizure count by 82% in 16 children with treatment-resistant epilepsy, with 56% achieving 50%+ reduction.
Quick Facts
What This Study Found
Median seizure count reduced by 81.9% from baseline. Monthly seizure frequency decreased by 73.4% (p<0.05). 56% of patients were responders (50%+ reduction), and 2 patients became seizure-free. 73% of caregivers reported improved condition; 82% reported reduced seizure severity. Treatment adherence was 96.3%.
Key Numbers
16 enrolled, 11 completed; mean age 9.1 years; average dose 13.6 mg/kg/day; 81.9% median seizure reduction; 56% responders; 2 seizure-free; adherence 96.3%; AEs: insomnia 25%, somnolence 18.8%.
How They Did This
Phase II, open-label, single-center study. 16 pediatric patients with TRE (history of 4+ failed AEDs). 4-week baseline, 2-week titration (up to 25 mg/kg or 450 mg), 10-week maintenance. Average maintenance dose 13.6 mg/kg/day.
Why This Research Matters
CBD bioavailability is a major challenge. This gelatin bead formulation (PTL-101) addresses that issue, and the 82% seizure reduction and high adherence (96%) suggest the formulation matters for clinical outcomes.
The Bigger Picture
Multiple CBD formulations are now being developed to improve on the original Epidiolex formulation. PTL-101's gelatin bead technology represents one approach, and its high response rate warrants larger controlled trials.
What This Study Doesn't Tell Us
Open-label, no control group, single center, small sample (16). 5 patients dropped out. The 82% reduction may partly reflect regression to the mean or placebo effects without a control group.
Questions This Raises
- ?How does PTL-101 compare head-to-head with Epidiolex?
- ?Does the improved bioavailability allow lower effective doses?
Trust & Context
- Key Stat:
- 82% seizure reduction
- Evidence Grade:
- Preliminary: small open-label phase II study without controls.
- Study Age:
- Published in 2019.
- Original Title:
- The safety, tolerability, and effectiveness of PTL-101, an oral cannabidiol formulation, in pediatric intractable epilepsy: A phase II, open-label, single-center study.
- Published In:
- Epilepsy & behavior : E&B, 98(Pt A), 233-237 (2019)
- Authors:
- Mitelpunkt, Alexis, Kramer, Uri(4), Hausman Kedem, Moran, Zilbershot Fink, Efrat, Orbach, Rotem, Chernuha, Veronika, Fattal-Valevski, Aviva, Deutsch, Lisa, Heffetz, Daphna, Sacks, Hagit
- Database ID:
- RTHC-02185
Evidence Hierarchy
A small preliminary study to test whether a larger study is feasible.
What do these levels mean? →Frequently Asked Questions
What makes PTL-101 different from other CBD products?
PTL-101 uses gelatin matrix beadlets designed to improve CBD absorption and maintain consistent transit through the digestive system, potentially improving bioavailability.
How effective was PTL-101 for seizures?
Median seizure count dropped 82%, 56% of children had at least 50% fewer seizures, and 2 patients became seizure-free during the 12-week study.
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Cite This Study
https://rethinkthc.com/research/RTHC-02185APA
Mitelpunkt, Alexis; Kramer, Uri; Hausman Kedem, Moran; Zilbershot Fink, Efrat; Orbach, Rotem; Chernuha, Veronika; Fattal-Valevski, Aviva; Deutsch, Lisa; Heffetz, Daphna; Sacks, Hagit. (2019). The safety, tolerability, and effectiveness of PTL-101, an oral cannabidiol formulation, in pediatric intractable epilepsy: A phase II, open-label, single-center study.. Epilepsy & behavior : E&B, 98(Pt A), 233-237. https://doi.org/10.1016/j.yebeh.2019.07.007
MLA
Mitelpunkt, Alexis, et al. "The safety, tolerability, and effectiveness of PTL-101, an oral cannabidiol formulation, in pediatric intractable epilepsy: A phase II, open-label, single-center study.." Epilepsy & behavior : E&B, 2019. https://doi.org/10.1016/j.yebeh.2019.07.007
RethinkTHC
RethinkTHC Research Database. "The safety, tolerability, and effectiveness of PTL-101, an o..." RTHC-02185. Retrieved from https://rethinkthc.com/research/mitelpunkt-2019-the-safety-tolerability-and
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.