Müller, A. R.
Zinkstok, J. R.
Rommelse, N. N. J.
van de Ven, P. M.
Roes, K. C. B.
Wijburg, F. A.
de Rooij-Askes, E.
Linders, C.
Boot, E.
van Eeghen, A. M. http://orcid.org/0000-0001-8149-8645
Clinical trials referenced in this document:
Documents that mention this clinical trial
Methylphenidate for attention-deficit/hyperactivity disorder in patients with Smith–Magenis syndrome: protocol for a series of N-of-1 trials
https://doi.org/10.1186/s13023-021-02003-z
Article History
Received: 12 March 2021
Accepted: 24 August 2021
First Online: 8 September 2021
Declarations
:
: This protocol is approved by the institutional review board of the Amsterdam UMC, location AMC (2020_100). The study will be conducted according to the principles of the Declaration of Helsinki (2013) and in accordance with the Dutch Medical Research Involving Human Subjects Act and Good Clinical Practice guidelines. The study is registered under EudraCT number 2020-004053-76, protocol no. NL73102.018.20, version 1.0, registration date 17 August 2020. Participants and caregivers who are interested will receive a letter with information. Subjects will be informed about the study and procedures by the treating physicians adjusted to their level of intellectual functioning. Subjects and/or legal representatives will receive as much time as they need to consider their decision with a maximum of three months with regard to the progress of the study. As the study population includes children and as most of the SMS subjects have ID, the substitute decision maker(s) will provide written consent. The research team and an independent physician is available to be contacted for any question during the entire trial period.
: Not applicable.
: The authors declare that they have no competing interest.