Trial document
This trial has been registered retrospectively.
DRKS00013177
Trial Description
Title
Observation of CBD therapy inpatients with intractable epilepsy
Trial Acronym
CBD-ET
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.
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
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
Secondary IDs
- [---]*
Health Condition or Problem studied
- G40 - Epilepsy
Interventions/Observational Groups
- Cannabidiol oily solution start 5mg/kg/d, up titrated according to tolerance to maximum of 50mg/kg/d.
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
Primary Outcome
Percentage change of seizure frequency per month of motor seizures after 3 months of CBD compared to 1 month of baseline
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
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2017/12/01
- 40
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 1 Months
- no maximum age
Additional Inclusion Criteria
pharmacoresistant epilepsy, treatment with at least one anticonvulsive drug, CBD therapy
Exclusion Criteria
cannabinoid treatment within 4 weeks of screening, pregnancy, instable hepatic or renal disease
Addresses
-
start of 1:1-Block address primary-sponsor
- Abteilung für Epileptologie des Universitätsklinikums Freiburg
- Ms. Dr. med. Kerstin Alexandra Klotz
- Breisacher Str. 64
- 79106 Freiburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +4976127043520
- +4976127043500
- kerstin.alexandra.klotz at uniklinik-freiburg.de
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Abteilung für Epileptologie des Universitätsklinikums Freiburg
- Ms. Dr. med. Kerstin Alexandra Klotz
- Breisacher Str 64
- 79106 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +4976127043520
- +4976127043500
- kerstin.alexandra.klotz at uniklinik-freiburg.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Abteilung für Epileptologie des Universitätsklinikums Freiburg
- Ms. Dr. med. Kerstin Alexandra Klotz
- Breisacher Str. 64
- 79106 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +4976127043520
- +4976127043500
- kerstin.alexandra.klotz at uniklinik-freiburg.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Abteilung für Epileptologie des Universitätsklinikums Freiburg
- Ms. Dr. med. Kerstin Alexandra Klotz
- Breisacher Str. 64
- 79106 Freiburg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +4976127043520
- +4976127043500
- kerstin.alexandra.klotz at uniklinik-freiburg.de
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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