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Trial record 50 of 540 for:    CBD

A Double-Blind Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epilepsy

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ClinicalTrials.gov Identifier: NCT02783092
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
Prati Donaduzzi & Cia Ltda
Information provided by (Responsible Party):
Antonio Waldo Zuardi, University of Sao Paulo

Brief Summary:

The purpose of this study is to assess the efficacy of the adjuvant use of cannabidiol administered twice daily in doses of 5-25 mg/kg/day through the proportion of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).

Primary end point(s): Rate of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).


Condition or disease Intervention/treatment Phase
Epilepsy Drug: Cannabidiol Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized Placebo-controlled Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epileptic Crisis in Children and Adolescents
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Cannabidiol
Concentration unit: 200mg/ml; 5 - 25 mg/Kg/day ; Oral solution
Drug: Cannabidiol
Oral solution of cannabidiol 200 mg / mL dissolved in corn oil. Titration period: 5 mg / kg / day up to 25 mg / kg / day. Maintenance period: highest dose obtained during the titration period (maximum of 25 mg/kg / day)
Other Name: CBD

Placebo Comparator: Placebo
Oral solution
Drug: Placebo
The placebo will be an oral solution of corn oil. Titration period: 5 mg / kg / day up to 25 mg / kg / day. Maintenance period: highest dose obtained during the titration period (maximum of 25 mg/kg / day)
Other Name: PLC




Primary Outcome Measures :
  1. Frequency of epileptic seizures [ Time Frame: 17 th week ]


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged 2 years to 18 years.
  • Diagnosis of treatment-resistant epilepsy according to the criteria of the International League Against Epilepsy (ILAE) (Kwan et al., 2010).
  • Participants with at least 4 epileptic seizures with intervals no longer than 21 days.
  • In treatment with up to 3 AEDs concomitantly and at stable doses for at least 1 month before the baseline assessment and expected to remain stable during the period of the trial. Vagus nerve stimulation (VNS) will be considered as an AED.
  • Availability of a legal guardian able to follow the protocol (e.g., understand and fill up diaries) and visitation and medication schemes, according to the decision of the investigator.
  • Availability of brain neuroimaging exams (magnetic resonance or computed tomography) collected within the last 5 years.
  • No significant comorbid conditions, according to medical decision, to other criteria in this Protocol, and to additional assessments: medical records, blood pressure, heart rate, and temperature measures, physical exam, ECG, EEG, and laboratory tests.
  • Women in reproductive age may be included as long as they are sexually abstinent or using effective contraceptive methods.
  • Participants and their legal guardians, when applicable, must sign an informed consent form approved by the local ethics committee.

Exclusion Criteria:

  • Occurrence of simple partial seizures (preserved consciousness) only, with no motor symptomatology.
  • History or presence of pseudoseizures.
  • History of suicide attempt.
  • History of major depression.
  • Pregnancy.
  • Drug use.
  • Hypertension.
  • Participants with severe dysphagia and no gastric or nasogastric tubes.
  • Current treatment with drugs that may significantly affect the metabolism of CBD, except AEDs if stable for at least 1 month before the screening interview.
  • Presence of any clinical or neuroimaging finding suggestive of brain disorders, brain tumors, or metabolic or neurodegenerative diseases of rapid progression.
  • Presence of acute and clinically significant diseases as assessed by a medical investigator, such as kidney, liver, urinary, bowel, or respiratory infections.
  • Presence of known chronic and clinically significant diseases as assessed by a medical investigator and which may interfere with participation in the trial or pose safety risks for the participant.
  • History of liver, kidney, lung, hematological, heart, or psychiatric diseases that may affect the volunteers' health or participation in the trial.
  • Hypotension or hypertension with any etiology and requiring pharmacological management.
  • History of surgeries that may affect the volunteers' health and/or participation in the trial.
  • Regular or intermittent use of marijuana over the 60 days preceding the baseline assessment.
  • Regular or intermittent treatment with CBD over the 60 days preceding the baseline assessment.
  • History of allergies or idiosyncratic reactions to Cannabis sativa derivatives or components of the pharmaceutical formulation.
  • Clinically significant ECG alterations as judged by a medical investigator.
  • Participation in other clinical trials within less than 3 months before the baseline assessment.
  • Donation or loss of 450 mL or more of blood within 90 days before the baseline assessment.
  • Impaired liver function: AST, ALP, alkaline phosphatase and γGT values more than 3 times above the upper limit of the reference value. Results of γGT values 3 times above the upper limit will only be accepted if attributable to liver enzymatic induction caused by concomitant treatment with AEDs and with levels of other liver enzymes lower than 3 times the upper limit of the reference range.
  • Participants with clinically significant discrepancies from the reference ranges of the following laboratory tests: creatinine clearance < 50 ml/min, platelets < 100.000/μL, and neutrophils < 1.800/μL.

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): NCT02783092


Locations
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Brazil
Unidade de Pesquisa Clínica HCRP-USP Recruiting
Ribeirao Preto, Sao Paulo, Brazil, 14048900
Contact: Jose A Crippa, MD, PhD    +551636022201    jcrippa@fmrp.usp.br   
Contact: Julia AT Pacheco, MD, PhD    +551636022632    jcpacheco@hcrp.usp.br   
Sponsors and Collaborators
Antonio Waldo Zuardi
Prati Donaduzzi & Cia Ltda

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Responsible Party: Antonio Waldo Zuardi, MD, PhD, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02783092     History of Changes
Other Study ID Numbers: CBD-PRATI-USP_01
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pharmaceutical Solutions
Epidiolex
Anticonvulsants