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
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: PLT101
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).
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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 |
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pediatric subjects with refractory epilepsy
- 2-15 years old (inclusive), male or female
- History of the any of the following seizure types: tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized, complex partial seizures and drop attacks (tonic/atonic).
- At least four clinically countable seizures within 4 weeks of study entry [tonic, clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily generalized or primary generalized and/or complex partial seizures and drop attacks (tonic/atonic)]
- Subject on a stable regimen of 1-4 concomitant antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to enrollment
- History of treatment with at least four AEDs, including one trial of a combination of two concomitant drugs, without successful seizure control
- Subjects with vagal nerve stimulation system must be on stable settings for a minimum of 6 months prior to enrollment
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For subjects undergoing dietary treatment (e.g., ketogenic or modified Atkins diet):
the fat to carbohydrate ratio must be stable for a minimum of eight weeks prior to enrollment
- The subject's legal guardian voluntarily provides consent for participation in the study and signs an Informed Consent Form
- Completed seizures diary for four weeks (±3 days) prior to initiation of the dose titration period (visit 2). Subject will be considered a screen failure if seizures diary was not appropriately completed.
Exclusion Criteria:
- The subject is currently using or has used cannabis-based or synthetic cannabinoid within three months of study entry
- Subject is unwilling to abstain from use of cannabis-based or synthetic cannabinoid throughout the study period
- Neurodegenerative or deteriorated neurological disease
- History of heart failure
- Known family history (first-degree) of psychiatric disorders
- Psychosis or past psychotic event and/or anxiety disorder
- Current or history of drug abuse/addiction
- Renal, hepatic (ALT/AST >2x upper limit of normal (ULN), bilirubin >2x ULN), pancreatic dysfunctions or laboratory test abnormalities, at the investigator's discretion
- Clinically significant finding in baseline ECG
- Initiation of felbamate treatment within 9 months of screening
- Allergy to CBD or any cannabinoid and/or formulation excipients
- Subject is pregnant, lactating, or planning a pregnancy during the course of the study or within 3 months of study completion
- Subject and legal guardian/caregiver unable to comply with study visits/requirements
- Subject is currently enrolled in, or has not yet completed a period of at least 60 days since ending another investigational device or drug trial(s)

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
Israel | |
Pediatric Epilepsy department- Souraskey Medical center | |
Tel Aviv, Israel |
Responsible Party: | PhytoTech Therapeutics, Ltd. |
ClinicalTrials.gov Identifier: | NCT02987114 |
Other Study ID Numbers: |
CS-100 |
First Posted: | December 8, 2016 Key Record Dates |
Last Update Posted: | September 6, 2018 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Epilepsy Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |