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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02987114
Recruitment Status : Completed
First Posted : December 8, 2016
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
PhytoTech Therapeutics, Ltd.

Brief 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.


Condition or disease Intervention/treatment Phase
Epilepsy Intractable Drug: PLT101 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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).
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




Primary Outcome Measures :
  1. Incidence of study treatment related adverse events (AEs) [ Time Frame: 12 weeks of treatment + 2 weeks follow up ]
  2. Percent change in mean countable monthly seizure frequency [ Time Frame: 12 week treatment period ]

Secondary Outcome Measures :
  1. Incidence of all adverse events (AEs) [ Time Frame: 12 weeks of treatment + 2 weeks follow up ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pediatric subjects with refractory epilepsy
  2. 2-15 years old (inclusive), male or female
  3. 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).
  4. 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)]
  5. Subject on a stable regimen of 1-4 concomitant antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to enrollment
  6. History of treatment with at least four AEDs, including one trial of a combination of two concomitant drugs, without successful seizure control
  7. Subjects with vagal nerve stimulation system must be on stable settings for a minimum of 6 months prior to enrollment
  8. 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

  9. The subject's legal guardian voluntarily provides consent for participation in the study and signs an Informed Consent Form
  10. 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:

  1. The subject is currently using or has used cannabis-based or synthetic cannabinoid within three months of study entry
  2. Subject is unwilling to abstain from use of cannabis-based or synthetic cannabinoid throughout the study period
  3. Neurodegenerative or deteriorated neurological disease
  4. History of heart failure
  5. Known family history (first-degree) of psychiatric disorders
  6. Psychosis or past psychotic event and/or anxiety disorder
  7. Current or history of drug abuse/addiction
  8. Renal, hepatic (ALT/AST >2x upper limit of normal (ULN), bilirubin >2x ULN), pancreatic dysfunctions or laboratory test abnormalities, at the investigator's discretion
  9. Clinically significant finding in baseline ECG
  10. Initiation of felbamate treatment within 9 months of screening
  11. Allergy to CBD or any cannabinoid and/or formulation excipients
  12. Subject is pregnant, lactating, or planning a pregnancy during the course of the study or within 3 months of study completion
  13. Subject and legal guardian/caregiver unable to comply with study visits/requirements
  14. 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)

Information from the National Library of Medicine

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


Locations
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Israel
Pediatric Epilepsy department- Souraskey Medical center
Tel Aviv, Israel
Sponsors and Collaborators
PhytoTech Therapeutics, Ltd.

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Responsible Party: PhytoTech Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT02987114     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epidiolex
Anticonvulsants