254
Views
29
CrossRef citations to date
0
Altmetric
Original Article

Design of phase II ALS clinical trials

&
Pages 16-23 | Received 28 Jun 2007, Accepted 13 Dec 2007, Published online: 10 Jul 2009

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (6)

Suma Babu, Eric A. Macklin, Katherine E. Jackson, Elizabeth Simpson, Katy Mahoney, Hong Yu, Jason Walker, Zachary Simmons, William S. David, Paul E. Barkhaus, Laura Simionescu, Mazen M. Dimachkie, Alan Pestronk, Johnny S. Salameh, Michael D. Weiss, Benjamin Rix Brooks, David Schoenfeld, Jeremy Shefner, Swati Aggarwal, Merit E. Cudkowicz & Nazem Atassi. (2020) Selection design phase II trial of high dosages of tamoxifen and creatine in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 21:1-2, pages 15-23.
Read now
H Blasco, F Patin, CR Andres, P Corcia & PH Gordon. (2016) Amyotrophic Lateral Sclerosis, 2016: existing therapies and the ongoing search for neuroprotection. Expert Opinion on Pharmacotherapy 17:12, pages 1669-1682.
Read now
Rubika Balendra, Ashley Jones, Naheed Jivraj, Catherine Knights, Catherine M. Ellis, Rachel Burman, Martin R. Turner, P. Nigel Leigh, Christopher E. Shaw & Ammar Al-Chalabi. (2014) Estimating clinical stage of amyotrophic lateral sclerosis from the ALS Functional Rating Scale. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 15:3-4, pages 279-284.
Read now
Merit E. Cudkowicz, Jon Katz, Dan H. Moore, Gilmore O’neill, Jonathan D. Glass, Hiroshi Mitsumoto, Stanley Appel, Bernard Ravina, Karl Kieburtz, Ira Shoulson, Petra Kaufmann, Jaffar Khan, Ericka Simpson, Jeremy Shefner, Bruce Levin, Valerie Cwik, David Schoenfeld, Swati Aggarwal, Michael P. McDermott & Robert G. Miller. (2010) Toward more efficient clinical trials for amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis 11:3, pages 259-265.
Read now
Vincent Meininger, Vivian E. Drory, P. Nigel Leigh, Albert Ludolph, Wim Robberecht & Vincenzo Silani. (2009) Glatiramer acetate has no impact on disease progression in ALS at 40 mg/day: A double- blind, randomized, multicentre, placebo-controlled trial. Amyotrophic Lateral Sclerosis 10:5-6, pages 378-383.
Read now
Veena Lanka & Merit Cudkowicz. (2008) Therapy development for ALS: Lessons learned and path forward. Amyotrophic Lateral Sclerosis 9:3, pages 131-140.
Read now

Articles from other publishers (23)

Swati Dhasmana, Anupam Dhasmana, Acharan S. Narula, Meena Jaggi, Murali M. Yallapu & Subhash C. Chauhan. (2022) The panoramic view of amyotrophic lateral sclerosis: A fatal intricate neurological disorder. Life Sciences 288, pages 120156.
Crossref
Kristiana Salmon & Angela Genge. 2021. Spectrums of Amyotrophic Lateral Sclerosis. Spectrums of Amyotrophic Lateral Sclerosis 161 180 .
David Alan Schoenfeld, Dianne M Finkelstein, Eric Macklin, Neta Zach, David L Ennist, Albert A Taylor & Nazem Atassi. (2019) Design and analysis of a clinical trial using previous trials as historical control. Clinical Trials 16:5, pages 531-538.
Crossref
Leonard H. van den BergEric SorensonGary GronsethEric A. MacklinJinsy AndrewsRobert H. BalohMichael BenatarJames D. BerryAdriano Chio, Philippe CorciaAngela GengeAmelie K. GubitzCatherine Lomen-HoerthChristopher J. McDermottErik P. PioroJeffrey Rosenfeld, Vincenzo SilaniMartin R. TurnerMarkus WeberBenjamin Rix BrooksRobert G. MillerHiroshi Mitsumoto. (2019) Revised Airlie House consensus guidelines for design and implementation of ALS clinical trials. Neurology 92:14.
Crossref
Ruben P.A. van Eijk, Stavros Nikolakopoulos, Toby A. Ferguson, Dawei Liu, Marinus J.C. Eijkemans & Leonard H. van den Berg. (2018) Increasing the efficiency of clinical trials in neurodegenerative disorders using group sequential trial designs. Journal of Clinical Epidemiology 98, pages 80-88.
Crossref
Bruce Levin. (2015) The futility study—Progress over the last decade. Contemporary Clinical Trials 45, pages 69-75.
Crossref
Spencer Phillips Hey. (2015) Ethics and epistemology of accurate prediction in clinical research. Journal of Medical Ethics 41:7, pages 559-562.
Crossref
D Schoenfeld. (2014) Optimizing phase II clinical trials: novel trial designs. Journal of the Peripheral Nervous System 19:S2, pages S18-S20.
Crossref
Spencer Phillips HeyJonathan Kimmelman. (2014) The questionable use of unequal allocation in confirmatory trials. Neurology 82:1, pages 77-79.
Crossref
Nazem Atassi, David Schoenfeld & Merit Cudkowicz. 2012. Clinical Trials in Neurology. Clinical Trials in Neurology 273 283 .
. 2012. Clinical Trials in Neurology. Clinical Trials in Neurology 215 308 .
Stegeman Dick F.Kleine Bert U.Lapatki Bernd G.Van Dijk Johannes P.. (2012) High-density Surface EMG: Techniques and Applications at a Motor Unit Level. Biocybernetics and Biomedical Engineering 32:3, pages 3-27.
Crossref
Dan H Moore, Jonathan S Katz & Robert G Miller. (2011) A review of clinical trial designs in amyotrophic lateral sclerosis. Neurodegenerative Disease Management 1:6, pages 481-490.
Crossref
Merit Cudkowicz, Michael E Bozik, Evan W Ingersoll, Robert Miller, Hiroshi Mitsumoto, Jeremy Shefner, Dan H Moore, David Schoenfeld, James L Mather, Donald Archibald, Mary Sullivan, Craig Amburgey, Juliet Moritz & Valentin K Gribkoff. (2011) The effects of dexpramipexole (KNS-760704) in individuals with amyotrophic lateral sclerosis. Nature Medicine 17:12, pages 1652-1656.
Crossref
Paul H. Gordon & Vincent Meininger. (2011) How can we improve clinical trials in amyotrophic lateral sclerosis?. Nature Reviews Neurology 7:11, pages 650-654.
Crossref
James D Berry & Merit E Cudkowicz. (2011) New considerations in the design of clinical trials for amyotrophic lateral sclerosis. Clinical Investigation 1:10, pages 1375-1389.
Crossref
Lorne Zinman & Merit Cudkowicz. (2011) Emerging targets and treatments in amyotrophic lateral sclerosis. The Lancet Neurology 10:5, pages 481-490.
Crossref
Matthew C Kiernan, Steve Vucic, Benjamin C Cheah, Martin R Turner, Andrew Eisen, Orla Hardiman, James R Burrell & Margaret C Zoing. (2011) Amyotrophic lateral sclerosis. The Lancet 377:9769, pages 942-955.
Crossref
A. ChiòG. BorgheroA. CalvoM. CapassoC. CaponnettoM. CorboF. GianniniG. LogroscinoJ. MandrioliN. MarcelloL. MazziniC. MogliaM.R. MonsurròG. MoraF. PattiM. PeriniV. PietriniF. PisanoE. PupilloM. SabatelliF. SalviV. SilaniI.L. SimoneG. SorarùM.R. TolaP. VolantiE. Beghi. (2010) Lithium carbonate in amyotrophic lateral sclerosis. Neurology 75:7, pages 619-625.
Crossref
Johannes P. van Dijk, Helenius J. Schelhaas, Ivo N. Van Schaik, Henny M.H.A. Janssen, Dick F. Stegeman & Machiel J. Zwarts. (2010) Monitoring disease progression using high‐density motor unit number estimation in amyotrophic lateral sclerosis. Muscle & Nerve 42:2, pages 239-244.
Crossref
Sanne Piepers, Jan H. Veldink, Sonja W. De Jong, Ingeborg Van Der Tweel, W‐Ludo Van Der Pol, Esther V. Uijtendaal, H. Jurgen Schelhaas, Hans Scheffer, Marianne De Visser, J. M. B. Vianney De Jong, John H. J. Wokke, Geert Jan Groeneveld & Leonard H. Van Den Berg. (2009) Randomized sequential trial of valproic acid in amyotrophic lateral sclerosis. Annals of Neurology 66:2, pages 227-234.
Crossref
Zachary Simmons. (2009) Can we eliminate placebo in ALS clinical Trials?. Muscle & Nerve 39:6, pages 861-865.
Crossref
Swati Aggarwal & Merit Cudkowicz. (2008) ALS drug development: Reflections from the past and a way forward. Neurotherapeutics 5:4, pages 516-527.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.