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University of Alabama at Birmingham (UAB) Adult CBD Program

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: NCT02700412
Recruitment Status : Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Jerzy P Szaflarski, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE February 24, 2016
First Posted Date  ICMJE March 7, 2016
Last Update Posted Date May 17, 2019
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2016)
  • Evaluate severe adverse events (increase in seizure frequency by more than 100% or any hospitalization related to increase in seizure frequency) [ Time Frame: for 3 years ]
  • Evaluate any change in resting blood pressure or heart rate by 25% [ Time Frame: for 3 years ]
  • Evaluate any change in, CBC, CMP, Liver function tests (LFTSs), Urinary Analysis or Antiepileptic drug (AED) levels considered by managing neurologists as clinically significant. [ Time Frame: bi-weekly ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2016)
  • Evaluate decrease in seizure frequency as measured in total number of seizures per week month [ Time Frame: for 3 years ]
  • Evaluate decrease in seizure severity as measured by the Chalfont Seizure Severity Scale. [ Time Frame: for 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE University of Alabama at Birmingham (UAB) Adult CBD Program
Official Title  ICMJE University of Alabama at Birmingham (UAB) Adult CBD Program
Brief Summary The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating debilitating, drug-resistant epilepsy.
Detailed Description The specific goals of this phase 1 dose finding study conducted in consecutively enrolled patients 15 years and older are to prospectively and longitudinally assess the safety and tolerability, including cognitive effects, of CBD at various doses between 5 mg/kg/day and 25 mg/kg/day with additional titration in some cases up to 50 mg/kg/day. In order to participate in the study, participants will need to fulfill the inclusion and exclusion criteria.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Seizures
Intervention  ICMJE Drug: Epidiolex
The titration of CBD will start with a dose of 5 mg/kg/day given in two divided doses and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day; in some patients additional titration by 5mg/kg/day every 2 weeks up to 50mg/kg/day may be instituted at the discretion of the PI upon discussion with the Co-PI
Other Name: Cannabidiol
Study Arms  ICMJE Experimental: 5 mg/kg/day
The titration of CBD will start with a dose of 5 mg/kg/day given in two divided doses and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day; in some patients additional titration by 5mg/kg/day every 2 weeks up to 50mg/kg/day may be instituted at the discretion of the PI upon discussion with the Co-PI.
Intervention: Drug: Epidiolex
Publications * Warren PP, Bebin EM, Nabors LB, Szaflarski JP. The use of cannabidiol for seizure management in patients with brain tumor-related epilepsy. Neurocase. 2017 Oct - Dec;23(5-6):287-291. doi: 10.1080/13554794.2017.1391294. Epub 2017 Oct 24.

*   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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Any patient with disabling epilepsy with diagnosis confirmed by video/EEG monitoring and

    • Patient should have history of a trial of at least four AEDs including one trial of a combination of two concomitant AEDs, without successful seizure control. Vagus nerve stimulation (VNS), RNS deep brain stimulation, or the ketogenic diet can be considered an equivalent to a drug trial,
    • Between 1-4 baseline anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to submitting records for review by the CBD Treatment Approval Committee.
    • VNS or RNS must be on stable settings for a minimum of 3 months,
    • If on ketogenic diet, must be on stable ratio for a minimum of 3 months.
  • The referring provider needs to make available for review all of the following:
  • Most recent Brain MRI report,
  • Most recent ECG report,
  • Video/EEG monitoring report confirming the diagnosis of epilepsy,
  • Evidence that the patient has failed 4 AEDs as indicated above,
  • Current Medication List
  • Patient must have at least 4 clinically countable seizures per month. Seizure history to include a documented history of generalized seizures (drop attacks, atonic, tonic-clonic and/or myoclonic), focal seizures without loss of consciousness with a motor component, focal seizures with loss of consciousness, or focal seizures with secondary generalization,
  • Results of routine testing including blood work (CBC,CMP liver function tests (LFTs), renal panel, Urinary Analysis, and levels of all AEDs) and digital copy of a routine EEG along with the formal written report performed within 3 months prior to submitting records for CBD Treatment Approval review. If any AED dose was adjusted within three months prior to submitting records for CBD Treatment Approval Committee review, level on the new dose will need to be provided. If applicable, results of any metabolic or genetic testing performed should be included in submitted records for review:.
  • If applicable, documentation (including date of surgery) of prior VNS, RNS, Corpus Callosotomy, or other epilepsy surgery the patient has received.
  • Age 15 years and older,
  • Patients are able to keep and provide seizure calendar for at least 3 months prior to submitting records for CBD Treatment Approval Committee review. The patient will need to provide an updated calendar at the time of enrollment,
  • Acceptable method of contraception (or abstinence) for women of childbearing potential and for male patients with partners of childbearing potential; female patients must have_a negative urine pregnancy test on the day of initiating CBD,
  • For patients who agree to participate in the optional neuroimaging substudy, an MRI screen will be obtained to show that the patient does not have contraindication to receiving MRI/fMRI at 3 Tesla (e.g., metallic artifact).
  • Approval for inclusion by the CBD Treatment Approval Committee.
  • Current State of Alabama Resident
  • Acceptable documentation of Alabama residency includes the following:

    • a state issued ID, such as a driver's license, from patient or patient's parent/ legally authorized representative (LAR).
    • documents showing the patient or patient's parent/LAR rents/owns property in the state,
    • state voter registration from patient or patient's parent/LAR, or
    • a recent state tax return from patient or patient's parent/LAR.

Exclusion Criteria:

  • Active psychogenic non-epileptic seizures (PNES); Patients with more than 1 year freedom from PNES will not be excluded,
  • Patients who are pregnant, breastfeeding, or not using acceptable methods of contraception during the course of the study and for three months thereafter,
  • Male patient's partner is of child bearing potential; unless willing to ensure that they (male patients) or their partner(s) are using acceptable methods of contraception during the course of the study and for three months thereafter
  • History of substance abuse/addiction,
  • Use of medical marijuana or CBD based product in the past 30 days,
  • Initiation of felbamate within last 12 months,
  • Allergy to CBD or any marijuana-type products,
  • ALT >5 x ULN or AST >5 x ULN, as seen in participant's laboratory results submitted to the CBD Treatment Approval Committee for review.
  • Hemoglobin <1 0 or Hematocrit <30 or WBC < 2000, as seen in participant's laboratory results submitted to the CBD Treatment Approval Committee for review.
  • In investigator's judgment, active medical condition/treatment that impacts study activities.
  • Unable to provide consent (and no LAR),
  • Unable/Failure to comply with study visits/requirements and/or instructions,
  • Confirmed diagnosis for Dravet Syndrome or Lennox Gastaut Syndrome that qualifies the patient for a GW Dravet Syndrome or Lennox Gastaut Syndrome randomized controlled clinical trial for which the patient is eligible pursuant to the GW clinical trial enrollment criteria unless

    (a) there is no study that is either actively open for enrollment of patients at UAB or that is expected to actively begin enrolling patients at The University of Alabama at Birmingham within two (2) months of the date on which the patient is screened for the UAB Pediatric CBD Program or UAB Adult CBD Program,

  • Subjects with contraindications to MRI/fMRI at 3 Tesla (e.g., metallic artifact) will not be offered participation in the optional substudy.
  • Primary residence in a State different than Alabama.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02700412
Other Study ID Numbers  ICMJE IND# 124138
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jerzy P Szaflarski, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jerzy Szaflarski, MD, PhD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date May 2019

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