Night monitoring and emergency therapy for Dravet syndrome
Organizational Data
- DRKS-ID:
- DRKS00016967
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2019-05-27
- Last update in DRKS:
- 2019-05-27
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
In the study presented, a retrospective questionnaire and a prospective diary will be used to evaluate the influence of Dravet syndrome and nightly seizures or emergency situations on caregivers.
Brief summary in scientific language
Study using a retrospective questionnaire and a prospective diary to evaluate the influence of Dravet syndrome and nightly seizures or emergency situations on patients and caregivers.
Health condition or problem studied
- ICD10:
- G40 - Epilepsy
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Survey of patients with Dravet Syndrome and their caregivers
Endpoints
- Primary outcome:
- Use of monitoring devices, medical and non-medical treatment
- Secondary outcome:
- Care giver burden
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Epilepsiezentrum Frankfurt Rhein-Main Frankfurt a.M.
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2019-04-22
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Dravet-Syndrome
Exclusion Criteria
No Entry
Addresses
Primary Sponsor
- Address:
- Epilepsiezentrum Frankfurt Rhein-MainProf. Dr. Adam StrzelczykSchleusenweg 2-1665208 Frankfurt am MainGermany
- Telephone:
- +49-69-6301-7466
- Fax:
- +49-69-6301-84466
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Epilepsiezentrum Frankfurt Rhein-MainProf. Dr. Adam StrzelczykSchleusenweg 2-1665208 Frankfurt am MainGermany
- Telephone:
- +49-69-6301-7466
- Fax:
- +49-69-6301-84466
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de
Contact for Public Queries
- Address:
- Epilepsiezentrum Frankfurt Rhein-MainProf. Dr. Adam StrzelczykSchleusenweg 2-1665208 Frankfurt am MainGermany
- Telephone:
- +49-69-6301-7466
- Fax:
- +49-69-6301-84466
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de
Principal Investigator
- Address:
- Epilepsiezentrum Frankfurt Rhein-MainProf. Dr. Adam StrzelczykSchleusenweg 2-1665208 Frankfurt am MainGermany
- Telephone:
- +49-69-6301-7466
- Fax:
- +49-69-6301-84466
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Landes-Offensive zur Entwicklung Wissenschaftlich-ökonomischer Exzellenz (LOEWE) desHessischen Ministeriums für Wissenschaft und KunstRheinstraße 23-2565185 WiesbadenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://wissenschaft.hessen.de/wissenschaft/landesprogramm-loewe
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Epilepsiezentrum Frankfurt Rhein-MainSchleusenweg 2-1665208 Frankfurt am MainGermany
- Telephone:
- +49-69-6301-7466
- Fax:
- +49-69-6301-84466
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin Universitätsklinikum der Goethe-Universität c/o UniversitätsklinikumTheodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-21160590 Frankfurt/MainGermany
- Telephone:
- +49-69-63017239
- Fax:
- +49-69-630183434
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-01-22
- Ethics committee number:
- 40/19
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-04-02
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry