Cleary, Yumi http://orcid.org/0000-0002-9703-7269
Kletzl, Heidemarie
Grimsey, Paul
Heinig, Katja
Ogungbenro, Kayode http://orcid.org/0000-0003-2446-6895
Silber Baumann, Hanna Elisabeth
Frey, Nicolas
Aarons, Leon http://orcid.org/0000-0003-2704-6570
Galetin, Aleksandra
Gertz, Michael
Clinical trials referenced in this document:
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Estimation of FMO3 Ontogeny by Mechanistic Population Pharmacokinetic Modelling of Risdiplam and Its Impact on Drug–Drug Interactions in Children
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185 JEWELFISH: Safety, pharmacodynamic and exploratory efficacy data in non-naïve patients with SMA receiving risdiplam
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182 Pooled safety data from the risdiplam clinical development programme
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255 SUNFISH part 2: risdiplam in type 2 and type 3 SMA
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185 JEWELFISH: Safety, pharmacodynamic and exploratory efficacy data in non-naïve patients with SMA receiving risdiplam
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182 Pooled safety data from the risdiplam clinical development programme
https://doi.org/10.1136/jnnp-2022-abn2.226
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JEWELFISH: 24-month safety and pharmacodynamic data in non-treatment- naïve patients with spinal muscular atrophy (SMA)
https://doi.org/10.1136/jnnp-2023-abn.177
Estimation of FMO3 Ontogeny by Mechanistic Population Pharmacokinetic Modelling of Risdiplam and Its Impact on Drug–Drug Interactions in Children
https://doi.org/10.1007/s40262-023-01241-7
182 Pooled safety data from the risdiplam clinical development programme
https://doi.org/10.1136/jnnp-2022-abn2.226
Safety update: risdiplam clinical trial programme for spinal muscular atrophy (SMA)
https://doi.org/10.1136/jnnp-2023-abn.178
131 Pooled safety data from the risdiplam clinical trial development programme
https://doi.org/10.1136/jnnp-2022-abn.456
Documents that mention this clinical trial
Estimation of FMO3 Ontogeny by Mechanistic Population Pharmacokinetic Modelling of Risdiplam and Its Impact on Drug–Drug Interactions in Children
https://doi.org/10.1007/s40262-023-01241-7
Funding for this research was provided by:
F. Hoffmann-La Roche
Article History
Accepted: 19 March 2023
First Online: 6 May 2023
Declarations
:
: Yumi Cleary, Heidemarie Kletzl, Paul Grimsey, Katja Heinig, Hanna E. Silber Baumann, Nicolas Frey and Michael Gertz are employees of F. Hofmann-La Roche, Ltd, and hold stocks/stock options with F. Hoffmann-La Roche, Ltd. Kayode Ogungbenro, Leon Aarons and Aleksandra Galetin declared no competing interests for this work.
: All relevant study documents were approved by the Institutional Review Board and all subjects or their guardians signed the informed consent prior to enrolment. The studies were conducted in full conformance with the principles of the Declaration of Helsinki and its later amendments or comparable ethical standards.
: Informed consent was obtained from all individual participants included in the studies discussed.
: This study was funded by F. Hoffmann-La Roche Ltd. Open access publication of this manuscript was sponsored by F. Hoffmann-La Roche, Ltd.
: Qualified researchers may request access to individual patient-level data through the clinical study data request platform (ExternalRef removed). Further details on Roche’s criteria for eligible studies are available at ExternalRef removed. For further details on Roche’s Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see ExternalRef removed.