Garcia-Borreguero, Diego; Black, Jed; Earley, Christopher J; Fulda, Stephany; Högl, Birgit; Manconi, Mauro; Ondo, William; Roth, Thomas; Trenkwalder, Claudia; Winkelman, John W (2024). Rethinking clinical trials in restless legs syndrome: A roadmap. Sleep medicine reviews, 77(101978), p. 101978. Elsevier 10.1016/j.smrv.2024.101978
![[img]](https://boris.unibe.ch/style/images/fileicons/text.png) |
Text
1-s2.0-S1087079224000820-main.pdf - Published Version Restricted to registered users only Available under License Publisher holds Copyright. Download (954kB) |
The number of large clinical trials of restless legs syndrome (RLS) have decreased in recent years, this coincides with reduced interest in developing and testing novel pharmaceuticals. Therefore, the International Restless Legs Syndrome Study Group (IRLSSG) formed a task force of global experts to examine the causes of these trends and make recommendations to facilitate new clinical trials. In our article, we delve into potential complications linked to the diagnostic definition of RLS, identify subpopulations necessitating more attention, and highlight issues pertaining to endpoints and study frameworks. In particular, we recommend developing alternative scoring methods for more accurate RLS diagnosis, thereby improving clinical trial specificity. Furthermore, enhancing the precision of endpoints will increase study effect sizes and mitigate study costs. Suggestions to achieve this include developing online, real-time sleep diaries with high-frequency sampling of nightly sleep latency and the use of PLMs as surrogate markers. Furthermore, to reduce the placebo response, strategies should be adopted that include placebo run-in periods. As RLS is frequently a chronic condition, priority should be given to long-term studies, using a randomized, placebo-controlled, withdrawal design. Lastly, new populations should be investigated to develop targeted treatments such as mild RLS, pregnancy, hemodialysis, or iron-deficient anemia.
Item Type: |
Journal Article (Review Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology |
UniBE Contributor: |
Manconi, Mauro |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1532-2955 |
Publisher: |
Elsevier |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
09 Aug 2024 13:43 |
Last Modified: |
10 Sep 2024 00:15 |
Publisher DOI: |
10.1016/j.smrv.2024.101978 |
PubMed ID: |
39102777 |
Uncontrolled Keywords: |
Clinical trials Endpoints Future Industry Pharmaceutical Restless legs syndrome Study designs Treatment |
BORIS DOI: |
10.48350/199504 |
URI: |
https://boris.unibe.ch/id/eprint/199504 |
Actions (login required)
 |
Edit item |