van den Munckhof, Bart
,
Arzimanoglou, Alexis
Perucca, Emilio
van Teeseling, Heleen C.
Leijten, Frans S. S.
Braun, Kees P. J.
Jansen, Floor E.
Funding for this research was provided by:
Epilepsiefonds (13-17)
Wilhelmina Kinderziekenhuis (R2634)
European Clinical Research Infrastructures Network
Article History
Received: 18 May 2020
Accepted: 4 November 2020
First Online: 23 November 2020
Ethics approval and consent to participate
: Approval for the conduct of the study was received by the ethics committee of the University Medical Center Utrecht in December 2013 (protocol number 13-275/NL43510.041.13) and subsequently by the ethics committees/institutional review boards of 15 other centres as specified above under the “InternalRef removed” section. Changes in the study protocol have been/will be proposed to ethics committees/institutional review boards, communicated to trial site principal investigators by email and in regular investigator meetings (online meetings and meetings at international congresses). Depending on the implications of the changes, these have been/will also be communicated to patients/parents and the trial registry (ISRCTN). Since the first approval of the study protocol, two amendments have been submitted (approved in January 2016 and February 2018). These amendments had no impact on the patients that were already included in the study. Patients were included in the study if informed consent was obtained by their parents/legal representatives as described in the “InternalRef removed” section (subheading “InternalRef removed”). The trial is conducted in accordance with the principles of the Declaration of Helsinki, as amended by the World Medical Association General Assembly in October 2013, with the ICH guidelines for Good Clinical Practice (CPMP/ICH/135/95, July 1996) and with all international laws and regulations (including EU Clinical Trial Directive 2001/20/EC) and national laws and regulations of the countries in which the clinical trial is performed. The protocol (version 11, 25 November 2014) has been prepared and reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist (Additional file InternalRef removed).
: Not applicable.
: The authors declare that they have no competing interests.