<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02987114</url>
  </required_header>
  <id_info>
    <org_study_id>CS-100</org_study_id>
    <nct_id>NCT02987114</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Tolerability and Efficacy of Oral Administration of PTL101 (Cannabidiol) as an Adjunctive Treatment for Pediatric Intractable Epilepsy</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PhytoTech Therapeutics, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PhytoTech Therapeutics, Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety, tolerability and efficacy of oral administration of PTL101&#xD;
      (cannabidiol) for the treatment for pediatric intractable epilepsy.&#xD;
&#xD;
      Study will include a 4-week observation period ,12 weeks of treatment and 2 weeks of follow&#xD;
      up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, single-center study recruiting approximately 15 male or female&#xD;
      pediatric (ages 2-15, inclusive) patients with, intractable epilepsy, on stable doses of&#xD;
      antiepileptic drugs (AEDs). The study comprised of the following period: 4 weeks observation&#xD;
      period, followed by a 2-week dose titration period, 10-week maintenance treatment period, and&#xD;
      a 2-week follow-up of which 1 week is a tapering-off period. Seizures will be recorded by the&#xD;
      legal guardian/caregiver in seizure diaries throughout the first 16 weeks of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Actual">June 28, 2018</completion_date>
  <primary_completion_date type="Actual">June 28, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of study treatment related adverse events (AEs)</measure>
    <time_frame>12 weeks of treatment + 2 weeks follow up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change in mean countable monthly seizure frequency</measure>
    <time_frame>12 week treatment period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of all adverse events (AEs)</measure>
    <time_frame>12 weeks of treatment + 2 weeks follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessment of Caregiver Global Impression of Improvement using a 5-point rating scale</measure>
    <time_frame>after 5 weeks of maintenance dose and at end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessment of Caregiver Global Impression of Seizure Severity using a 5-point rating scale</measure>
    <time_frame>after 5 weeks of maintenance dose and at end of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Epilepsy Intractable</condition>
  <arm_group>
    <arm_group_label>PLT101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PLT101</intervention_name>
    <description>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</description>
    <arm_group_label>PLT101</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pediatric subjects with refractory epilepsy&#xD;
&#xD;
          2. 2-15 years old (inclusive), male or female&#xD;
&#xD;
          3. History of the any of the following seizure types: tonic, clonic, tonic-clonic in the&#xD;
             form of partial seizures, partial seizures secondarily generalized or primary&#xD;
             generalized, complex partial seizures and drop attacks (tonic/atonic).&#xD;
&#xD;
          4. At least four clinically countable seizures within 4 weeks of study entry [tonic,&#xD;
             clonic, tonic-clonic in the form of partial seizures, partial seizures secondarily&#xD;
             generalized or primary generalized and/or complex partial seizures and drop attacks&#xD;
             (tonic/atonic)]&#xD;
&#xD;
          5. Subject on a stable regimen of 1-4 concomitant antiepileptic drugs (AEDs) for a&#xD;
             minimum of 4 weeks prior to enrollment&#xD;
&#xD;
          6. History of treatment with at least four AEDs, including one trial of a combination of&#xD;
             two concomitant drugs, without successful seizure control&#xD;
&#xD;
          7. Subjects with vagal nerve stimulation system must be on stable settings for a minimum&#xD;
             of 6 months prior to enrollment&#xD;
&#xD;
          8. For subjects undergoing dietary treatment (e.g., ketogenic or modified Atkins diet):&#xD;
&#xD;
             the fat to carbohydrate ratio must be stable for a minimum of eight weeks prior to&#xD;
             enrollment&#xD;
&#xD;
          9. The subject's legal guardian voluntarily provides consent for participation in the&#xD;
             study and signs an Informed Consent Form&#xD;
&#xD;
         10. Completed seizures diary for four weeks (±3 days) prior to initiation of the dose&#xD;
             titration period (visit 2). Subject will be considered a screen failure if seizures&#xD;
             diary was not appropriately completed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is currently using or has used cannabis-based or synthetic cannabinoid&#xD;
             within three months of study entry&#xD;
&#xD;
          2. Subject is unwilling to abstain from use of cannabis-based or synthetic cannabinoid&#xD;
             throughout the study period&#xD;
&#xD;
          3. Neurodegenerative or deteriorated neurological disease&#xD;
&#xD;
          4. History of heart failure&#xD;
&#xD;
          5. Known family history (first-degree) of psychiatric disorders&#xD;
&#xD;
          6. Psychosis or past psychotic event and/or anxiety disorder&#xD;
&#xD;
          7. Current or history of drug abuse/addiction&#xD;
&#xD;
          8. Renal, hepatic (ALT/AST &gt;2x upper limit of normal (ULN), bilirubin &gt;2x ULN),&#xD;
             pancreatic dysfunctions or laboratory test abnormalities, at the investigator's&#xD;
             discretion&#xD;
&#xD;
          9. Clinically significant finding in baseline ECG&#xD;
&#xD;
         10. Initiation of felbamate treatment within 9 months of screening&#xD;
&#xD;
         11. Allergy to CBD or any cannabinoid and/or formulation excipients&#xD;
&#xD;
         12. Subject is pregnant, lactating, or planning a pregnancy during the course of the study&#xD;
             or within 3 months of study completion&#xD;
&#xD;
         13. Subject and legal guardian/caregiver unable to comply with study visits/requirements&#xD;
&#xD;
         14. Subject is currently enrolled in, or has not yet completed a period of at least 60&#xD;
             days since ending another investigational device or drug trial(s)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pediatric Epilepsy department- Souraskey Medical center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>September 5, 2018</last_update_submitted>
  <last_update_submitted_qc>September 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Drug Resistant Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02987114
org study id: CS-100
nct id: NCT02987114
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of study treatment related adverse events (AEs)
time frame: 12 weeks of treatment + 2 weeks follow up
measure: Percent change in mean countable monthly seizure frequency
time frame: 12 week treatment period
measure: Incidence of all adverse events (AEs)
time frame: 12 weeks of treatment + 2 weeks follow up
measure: 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
measure: 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
arm group label: PLT101
arm group type: Experimental
description: 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 type: Drug
intervention name: PLT101
description: 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
arm group label: PLT101
criteria: 
gender: All
minimum age: 2 Years
maximum age: 15 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Drug Resistant Epilepsy
sharing ipd: No