Trial document




This trial has been registered retrospectively.
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  DRKS00013177

Trial Description

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Title

Observation of CBD therapy inpatients with intractable epilepsy

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Trial Acronym

CBD-ET

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URL of the Trial

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Brief Summary in Lay Language

Cannabidiol can be used as prescription only drug for treatment of pharmacoresistant epilepsy in Germany. Pharmacoresitant means that at least 2 anticonvulsive drugs have been used without success before. In this study, patients that recieve pure Cannabidiol will be observed regarding efficacy as evaluated with patients seizure diary and tolerance.

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Brief Summary in Scientific Language

Prospective observational open label study of add on pure cannabidiol in patients with pharmakoresistant epilepsy to evaluate efficacy of seizure control (seizure diary) and tolerance.

Amendment 19 June 2018 for change of protocol: patients older than 18 can be included

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013177
  •   2019/06/25
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  •   yes
  •   Approved
  •   397/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   G40 -  Epilepsy
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Interventions/Observational Groups

  •   Cannabidiol oily solution start 5mg/kg/d, up titrated according to tolerance to maximum of 50mg/kg/d.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   Yes
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Primary Outcome

Percentage change of seizure frequency per month of motor seizures after 3 months of CBD compared to 1 month of baseline

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Secondary Outcome

Percentage change of seizure frequency per month of all seizures after 3 months of CBD compared to 1 month of baseline plus change of motor and all seizures per month after 6,12,18,24,36 months of treatment compared to baseline

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/12/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Months
  •   no maximum age
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Additional Inclusion Criteria

pharmacoresistant epilepsy, treatment with at least one anticonvulsive drug, CBD therapy

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Exclusion Criteria

cannabinoid treatment within 4 weeks of screening, pregnancy, instable hepatic or renal disease

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Addresses

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    • Abteilung für Epileptologie des Universitätsklinikums Freiburg
    • Ms.  Dr. med.  Kerstin Alexandra  Klotz 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Abteilung für Epileptologie des Universitätsklinikums Freiburg
    • Ms.  Dr. med.  Kerstin Alexandra  Klotz 
    • Breisacher Str 64
    • 79106  Freiburg
    • Germany
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    • Abteilung für Epileptologie des Universitätsklinikums Freiburg
    • Ms.  Dr. med.  Kerstin Alexandra  Klotz 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung für Epileptologie des Universitätsklinikums Freiburg
    • Ms.  Dr. med.  Kerstin Alexandra  Klotz 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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