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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

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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.

Tracking Information
First Submitted Date  ICMJE December 6, 2016
First Posted Date  ICMJE December 8, 2016
Last Update Posted Date September 6, 2018
Actual Study Start Date  ICMJE February 13, 2017
Actual Primary Completion Date June 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • Incidence of study treatment related adverse events (AEs) [ Time Frame: during 100 days from screening ]
  • Percent change in mean countable monthly seizure frequency [ Time Frame: during the 10 week treatment period ]
Change History Complete list of historical versions of study NCT02987114 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • Incidence of all adverse events (AEs) [ Time Frame: during 100 days from screening ]
  • assessment of seizure improvement using a 5-point rating scale [ Time Frame: during the 10 week treatment period ]
  • assessment of seizure severity using a 5-point rating scale [ Time Frame: during the 10 week treatment period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability and Efficacy of Oral Administration of PTL101 (Cannabidiol) as an Adjunctive Treatment for Pediatric Intractable Epilepsy
Official Title  ICMJE 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
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy Intractable
Intervention  ICMJE 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
Study Arms  ICMJE 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).
Intervention: Drug: PLT101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2018)
16
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2016)
15
Actual Study Completion Date  ICMJE June 28, 2018
Actual Primary Completion Date June 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02987114
Other Study ID Numbers  ICMJE CS-100
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PhytoTech Therapeutics, Ltd.
Study Sponsor  ICMJE PhytoTech Therapeutics, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PhytoTech Therapeutics, Ltd.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP