NEALS PUBLICATIONS
     
These publications are either based on clinical trials performed by NEALS members using NEALS infrastructure or data from the NEALS databanks.  

A Randomized, Placebo-Controlled Trial of Topiramate in Amyotrophic Lateral Sclerosis.

Neurology, Aug 2003; 61: 456-464.

M.E. Cudkowicz, J.M. Shefner, D.A. Schoenfeld, R.H. Brown, Jr., H. Johnson, M. Qureshi, M. Jacobs, J.D. Rothstein, S.H. Appel, R.M. Pascuzzi, T.D. Heiman-Patterson, P.D. Donofrio, W.S. David, J.A. Russell, R. Tandan, E.P. Pioro, K.J. Felice, J. Rosenfeld, R.N. Mandler, G.M. Sachs, W.G. Bradley, W.M. Raynor, G.D. Baquis, J.M. Belsh, S. Novella, J. Goldstein, and J. Hulihan.

A Clinical Trial of Creatine in ALS

Neurology, Nov 2004; 63: 1656 - 1661.

J. M. Shefner, M.E. Cudkowicz, D. Schonfeld, T. Conrad, J. Taft, M. Chilton, L. Urbinelli, M. Qureshi, H. Zhang, A. Pestronk, J. Caress, E. Sorenson, W. Bradley, C. Lomen-Hoerth, E. Pioro, K. Rezania, M. Ross, R. Pascuzzi, T. Heiman-Patterson, R. Tandan, H. Mitsumoto, J. Rothstein, T. Smith-Palmer, D. MacDonald, D. Burke, and the NEALS Consortium.

Functional outcome measures as clinical trial endpoints in Amyotrophic Lateral Sclerosis

Neurology, 2004; 63:1933-5.

Traynor B, Zhang H, Shefner J, Schoenfeld D, Cudkowicz, M.

The Use of Statistical MUNE in a Multicenter Clinical Trial

Muscle and Nerve, 30: 463-469, 2004.

Trial of Celecoxib in Amyotrophic Lateral Sclerosis

 

Annals of Neurology, July 2006, Vol. 60, No 1, 22-31.

Merit. E. Cudkowicz, MD, MSc, Jeremy. M. Shefner, MD, PhD, David. A. Schoenfeld, PhD, Hui. Zhang, Katrin. I. Andreasson, MD, Jeffrey D. Rothstein, MD PhD, Daniel. B. Drachman, MD and the Northeast ALS Consortium.

Revised Statistical MUNE in the Celecoxib/ALS Trial

Muscle and Nerve, 2007, in press.

J. M. Shefner, M. E. Cudkowicz, H. Zhang, D. Schoenfeld, D. Jillapalli, and the Northeast ALS Consortium.

Tolerance of high-dose (3,000 mg/day) coenzyme Q10 in ALS

Neurology, 2005: 65(11):1834-6

K. L. Ferrante, BA, J. Shefner, MD, PhD, H. Zhang, MS, R. Betensky, PhD, M. O'Brien, MPH, PT, H. Yu, MS, M. Fantasia, MPH, J. Taft, MPAS, PA, M. F. Beal, MD, B. Traynor, MD, K. Newhall, BS, P. Donofrio, MD, J. Caress, MD, C. Ashburn, RN, MSN, B. Freiberg, PT, C. O'Neill, BS, C. Paladenech, RRT, T. Walker, RN, BSN, A. Pestronk, MD, B. Abrams, RN, J. Florence, MHS, DPT, R. Renna, RN, J. Schierbecker, MHS, PT, B. Malkus, MHS, PT and M. Cudkowicz, MD, MSc

Arimoclomol at Dosages up to 300 mg/day is Well Tolerated and Safe in Amyotrophic Lateral Sclerosis

Muscle & Nerve, in press 2008

Merit E. Cudkowicz, MD, MSc, Jeremy M. Shefner, MD, PhD, Elizabeth Simpson, et al.

Medications and laboratory parameters as prognostic factors in amyotrophic lateral sclerosis

Amyotrophic Lateral Sclerosis, 2008 (Accepted for publication)

Qureshi M, Shui A, DiBernardo A, Brown Jr R, Schoenfeld D, Cudkowicz M.

Phase 2 Study of Sodium Phenylbutyrate in ALS

Amyotrophic Lateral Sclerosis, Under Review, 2008.

Cudkowicz ME, Andres PL, MacDonald SA, Bedlack R, Choudry R, Brown RH, et al: 

Abstract (with poster) presented at ANA meeting, Chicago, IL, October 2006:

NEALS Arimoclomol Sites: A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS

Annals of Neurology, 2006; 60(S10); S13

M. Cudkowicz, J. Shefner, R. Brown, E. Simpson, H. Yu, H. Zhang, A. Opoliner, D. Grasso, D. Schoenfeld,
S. Wieland, J. Barber

Abstracts presented at 17th International Symposium on ALS/MND, Japan, December 2006:

Challenges of Data Management in Web-based Multi-site Clinical Trials in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis, 2006.  7:S1, Pages 1-180; 57-58.

A.V. Sherman, M.E. Cudkowicz, H. Yu, S. Balakrishna, A.F. Opoliner

Levetiracetam Treatment for Spasticity in Motor Neuron Diseases

Amyotrophic Lateral Sclerosis, 2006.  7:S1, Pages 1-180; 111-112.

R. Bedlack, M. Bellanich, M. Bromberg, M. Cudkowicz

A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS (Poster was presented)

Amyotrophic Lateral Sclerosis, 2006.  7:S1, Pages 1-180; 113.

M. Cudkowicz, J. Shefner, E. Simpson, D. Grasso, A. Sherman, H. Yu, A Opoliner, S. Balakrishna, D. Schoenfeld, H. Zhang, D. Finkelstein, J. Taft, M. Watson, A. DiBernardo, D. Pulley, A. Verma, D. Koggan, J. Steele, R. Bedlack, K. Grace, T. Heiman-Patterson, C. Barr, R. Barohn, M. Walsh, L. Herbelin, Z. Simmons, H. Stephens, E. Ensrud, M. Zimmerman, W. David, S. Conn, T. Mozaffar, V. Martin, J. Hung, D. Milan, S. Wieland, J. Barber, R. Brown

Unified Electronic Data Capture and Data Management System for Clinical Trials and Biomarker Studies in ALS

Amyotrophic Lateral Sclerosis, 2006.  7:S1, Pages 1-180; 115-116.

A.V. Sherman

Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects with ALS

Cudkowicz ME, Andres PL, Schoenfeld D, Zhang H, Sherman A, Yu H, Opoliner A, Choudry R, Kruczek K, MacDonald S, Matson W, Smith K, Hetherington W,  Loya P, Bedlack R, Golightly Y, Maragakis N, Clawson L, Mosier D, Ali N, Kasarskis E, Taylor D, Zivkovic S, Brice V, Sams L, Story M, Ferrante K,  Shefner J, Taft J, Brown R Ferrante, RJ 

Application of a Finite State Machine Model for Management of Multi-Site Clinical Trials in ALS

Sherman A., Opoliner A., Yu H., Chan M., Cudkowicz M., 18th International Symposium on ALS/MND, Toronto, Canada, December 2007

Comparison of Controlled Medical Vocabularies for Adverse Event Recoding in a Multi-Center Clinical Trial in ALS

Qureshi M., Sherman A., Yu H., Debernardo A., Choudry R., Cudkowicz M. 18th International Symposium on ALS/MND, Toronto, Canada, December 2007

Design and Implementation of a Multi-Phase, Adaptive-Design Clinical Trial for Subjects with ALS

Swartz A., Shefner J., Yu H., Thornell B., Sherman A., Cudkowicz M. 18th International Symposium on ALS/MND, Toronto, Canada, December 2007

Advantages of Automated Serious Adverse Events Management (SAEM) in Multi-site Clinical Trials in ALS

Sherman A.V., Opoliner A.F., Hong Yu, Chan M., Andres P.L., Cudkowicz M.E. 132d Annual Meeting of the American Neurological Association, Washington, D.C., October 2007

Introduction of Clinical Trials Management Systems in Web-based Multi-site Clinical Trials in Neurology Research

Sherman A.V., Cudkowicz M.E., Hong Yu, April Opoliner. 59th American Academy of Neurology, Boston, April 2007

Challenges of Data Management in Web-based Multi-site Clinical Trials in ASL

Sherman A.V. 17th International Symposium on ALS/MND, Yokohama, Japan, December 2006

Unified Electronic Data Capture and data management System for Clinical Trials and Biomarker Studies in ALS

Sherman A.V., Cudkowicz M.E. 17th International Symposium on ALS/MND, Yokohama, Japan, December 2006

Data Exchange Specifications for Semantically Heterogeneous Data Sources in ALS Research

Sherman A.V., Cudkowicz M.E.. 131st Annual Meeting of the American Neurological Association, Chicago, October 2006

Identification of Metabolic and Protein Biomarkers in the Cerebrospinal Fluid for Amyotrophic Lateral Sclerosis

Dibernardo, K.R. Kruczek, E.A. Welsh, K. Newhall, G. Royce-Nagel, K. Ferrante, A. Sherman, R. Bowser, R.H. Brown, M.E. Cudkowicz Massachusetts General Hospital Clinical Research Day, May 2006

Introduction of Electronic Data Capture and Data Management Technology to Investigator-initiated Clinical Trials and Biomarker Studies in an Academic Environment

Sherman A.V., Cudkowicz M.E. 16th International Symposium on ALS/MND, Dublin, Ireland, December 2005

Data Exchange Specifications for Biomarker Studies and Clinical Trials in ALS

Sherman A.V., Cudkowicz M.E., Brown R.H., Miller R.. 16th International Symposium on ALS/MND, Dublin, Ireland, December 2005


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