Carmland, Malin E.
Kreutzfeldt, Melissa
Holbech, Jakob V.
Andersen, Niels T.
Jensen, Troels S.
Bach, Flemming W.
Sindrup, Søren H.
Finnerup, Nanna B. http://orcid.org/0000-0001-5541-0240
Funding for this research was provided by:
Novo Nordisk Fonden (NNF17OC0029426)
Article History
Received: 17 January 2019
Accepted: 31 August 2019
First Online: 11 October 2019
Ethics approval and consent to participate
: This article describes protocol number LACOSAMIDE-2018, protocol version 1.2, dated 28 September 2018 with amendment to version 2.1, dated 21 June 2019. The study is approved by the Ethical Committee of the Central Denmark Region, which includes approval also for the Region of Southern Denmark, and thus there is local ethical approval for all participating centers (no. 1-10-72-264-18), the Danish Medicines Agency (no. 201881482), and the Data Protection Agency (via the Central Denmark region’s internal notification) (no. 2016-015000001). The study is registered with the EU Clinical Trials Register (Eudra CT 2018-003110-40) and ExternalRef removed (NCT03777956). Important protocol modifications will be communicated to all relevant parties mentioned above. Informed consent will be obtained from all participants from the investigators and we will follow the ICH Good Clinical Practice (GCP) guidelines, and the project will be monitored by the GCP units at Aarhus and Odense University Hospitals, for both planned and unplanned visits, according to a specific plan stated by the local GCP units. All methods used in the study are clinically established, and the project manager/staff have extensive clinical experience in using them.
: Not applicable.
: MEC, JVH, SHS, and NTA declare no competing interests. NBF has received honoraria for serving on advisory boards or speaker panels from Teva, Novartis, Astellas, Grünenthal, Mitshubishe Tanabe, Merck, and Novartis. TSJ has received honoraria for serving on advisory boards from Pfizer, Grünenthal, and Aptinyx. FWB has received honoraria for serving on advisory boards from Novartis and TEVA.