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Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration Volume 22, 2021 - Issue 5-6
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Clinical Trials

Challenges and opportunities for Multi-National Investigator-Initiated clinical trials for ALS: European and United States collaborations

Paul Lingor1 Department of Neurology, School of Medicine, Technical University of Munich, Klinikum rechts der Isar, München, GermanyCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0001-9362-7096View further author information
ORCID Icon,
Jan C. Koch2 Department of Neurology, University Medical Center Göttingen, Göttingen, GermanyView further author information
,
Jeffrey M. Statland3 Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas, USAView further author information
,
Sumaira Hussain4 Department of Neurology, University of Miami, Miami, Florida, USAView further author information
,
Christiane Hennecke5 Department for International Cooperations, University Medical Center Göttingen, Göttingen, GermanyView further author information
,
Joanne Wuu4 Department of Neurology, University of Miami, Miami, Florida, USAView further author information
,
Thomas Langbein6 Clinical Trials Unit, University Medical Center Göttingen, Göttingen, GermanyView further author information
,
Raees Ahmed5 Department for International Cooperations, University Medical Center Göttingen, Göttingen, GermanyView further author information
,
René Günther7 Department of Neurology, Technische Universität Dresden and German Center for Neurodegenerative Diseases, Dresden, GermanyView further author information
,
Benjamin Ilse8 Department of Neurology, Jena University Hospital, Jena, GermanyView further author information
,
Jan Kassubek9 Department of Neurology, RKU, University of Ulm, Ulm, GermanyView further author information
,
Katja Kollewe10 Department of Neurology, Hannover Medical School, Hannover, GermanyView further author information
,
Josua Kuttler2 Department of Neurology, University Medical Center Göttingen, Göttingen, GermanyView further author information
,
Andreas Leha11 Department of Medical Statistics, University Medical Center Göttingen, Göttingen, GermanyView further author information
,
Teresa Lengenfeld2 Department of Neurology, University Medical Center Göttingen, Göttingen, GermanyView further author information
,
Thomas Meyer12 Center for ALS and other Motor Neuron Disorders, Charité – Universitätsmedizin Berlin, Berlin, GermanyView further author information
,
Christoph Neuwirth13 Neuromuscular Disease Unit/ALS Clinic, Kantonsspital St. Gallen, St. Gallen, SwitzerlandView further author information
,
Ralf Tostmann5 Department for International Cooperations, University Medical Center Göttingen, Göttingen, GermanyView further author information
&
Michael Benatar4 Department of Neurology, University of Miami, Miami, Florida, USAORCID Iconhttps://orcid.org/0000-0003-4241-5135View further author information
ORCID Icon show all
Pages 419-425 | Received 08 Dec 2020, Accepted 17 Jan 2021, Published online: 03 Feb 2021

References

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  • Kaji R, Imai T, Iwasaki Y, Okamoto K, Nakagawa M, Ohashi Y, et al. Ultra-high-dose methylcobalamin in amyotrophic lateral sclerosis: a long-term phase II/III randomised controlled study. J Neurol Neurosurg Psychiatry. 2019;90:451–7.
  • Lingor P, Weber M, Camu W, Friede T, Hilgers R, Leha A, et al. ROCK-ALS: Protocol for a randomized, placebo-controlled, double-blind phase IIa trial of safety, tolerability and efficacy of the Rho kinase (ROCK) inhibitor fasudil in amyotrophic lateral sclerosis. Front Neurol. 2019;10:293.
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  • Tenti E, Simonetti G, Bochicchio MT, Martinelli G. Main changes in European Clinical Trials Regulation (No 536/2014). Contemp Clin Trials Commun. 2018;11:99–101.
  • Phillips M. International data-sharing norms: from the OECD to the General Data Protection Regulation (GDPR). Hum Genet. 2018;137:575–82.
  • Chico V. The impact of the general data protection regulation on health research. Br Med Bull. 2018;128:109–18.
  • BfArM. Consequences of Brexit for future and ongoing clinical trials [Internet]. Available at: https://www.bfarm.de/EN/Drugs/licensing/clinicalTrials/news/Consequences%20of%20Brexit%20for%20clinical%20trials.html. Accessed January 5, 2021.
  • van Eijk Ruben PA, Tessa K, J MC, B RKC, Van Damme P, Adriano C, et al. TRICALS: creating a highway toward a cure. Amyotroph Lateral Scler Frontotemporal Degener. 2020;21:496–501.

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