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

A

Antonio Waldo Zuardi

Status and phase

Active, not recruiting
Phase 3

Conditions

Epilepsy

Treatments

Drug: Placebo
Drug: Cannabidiol

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02783092
CBD-PRATI-USP_01

Details and patient eligibility

About

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).

Enrollment

126 estimated patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

126 participants in 2 patient groups, including a placebo group

Cannabidiol
Experimental group
Description:
Concentration unit: 200mg/ml; 5 - 25 mg/Kg/day ; Oral solution
Treatment:
Drug: Cannabidiol
Placebo
Placebo Comparator group
Description:
Oral solution
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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