Outcome measures for early phase clinical trials

Amyotrophic Lateral Sclerosis

Volumn 8, Issue 5, 2007, Pages 270-273

  Gordon, Paul H ^a   Cheng, Bin ^b   Montes, Jacqueline ^a   Doorish, Carolyn ^a   Albert, Steven M ^c   Mitsumoto, Hiroshi ^a  

^a Och Spine at New York Presbyterian Hospitals   (United States)

^b University of Pittsburgh ^*  (United States)

^c UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

ALS; Amyotrophic lateral sclerosis; Clinical trials; Outcome measures; Phase II trial

Indexed keywords

GLATIRAMER;

ALGORITHM; AMYOTROPHIC LATERAL SCLEROSIS; ARTICLE; CLINICAL ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; FORCED EXPIRATORY VOLUME; FUNCTIONAL ASSESSMENT; HUMAN; OUTCOME ASSESSMENT; PATIENT ATTITUDE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SCORING SYSTEM; SURVIVAL RATE; VISUAL ANALOG SCALE;

AMYOTROPHIC LATERAL SCLEROSIS; CLINICAL TRIALS AS TOPIC; DOUBLE-BLIND METHOD; HUMANS; IMMUNOSUPPRESSIVE AGENTS; OUTCOME ASSESSMENT (HEALTH CARE); PAIN MEASUREMENT; PEPTIDES; PROPORTIONAL HAZARDS MODELS; PROSPECTIVE STUDIES; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; SEVERITY OF ILLNESS INDEX;

EID: 35148871327     PISSN: 17482968     EISSN: 1471180X     Source Type: Journal    
DOI: 10.1080/17482960701547958     Document Type: Article

References (13)

1. Miller, R., Mitchell, J., Lyon, M. and Moore, D. (2007) Riluzole for amyotrophic laterals sclerosis (ALS)/motor neuron disease (MND). Cochrane database syst rev, 1, p. CD001447.
2. Gordon, P. H., Doorish, C., Montes, J., Mosley, R. L., Diamond, B. and Macarthur, R. B. (2006) Randomized controlled phase II trial of glatiramer acetate in ALS. Neurology, 66, pp. 1117-1119.
3. Cheung, Y. K., Gordon, P. H. and Levin, B. (2006) Selecting promising ALS therapies in clinical trials. Neurology, 67, pp. 1748-1751.
4. Great Lakes ALS Study Group (2003) A comparison of muscle strength testing techniques in amyotrophic lateral sclerosis. Neurology, 61, pp. 1503-1507.
5. Schmidt, E. P., Drachman, D. B., Wiener, C. M., Clawson, L., Kimball, R. and Lechtzin, N. (2006) Pulmonary predictors of survival in amyotrophic lateral sclerosis: Use in clinical trial design. Muscle & Nerve, 33, pp. 127-132.
6. Miller, R. G., Rosenberg, J. A., Gelinas, D. F., Mitsumoto, H., Newman, D. and Sufit, R. (1999) Practice parameter: The care of the patient with amyotrophic lateral sclerosis (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology: ALS Practice Parameters Task Force. Neurology, 52, pp. 1311-1323.
7. Levy, G., Kaufmann, P., Buchsbaum, R., Montes, J., Barsdorf, A. and Arbing, R. (2006) A two-stage design for a phase II clinical trial of coenzyme Q10 in ALS. Neurology, 66, pp. 660-663.
8. Scelsa, S. N., MacGowan, D. J., Mitsumoto, H., Imperato, T., LeValley, A. J. and Liu, M. H. (2005) A pilot, double-blind, placebo-controlled trial of indinavir in patients with ALS. Neurology, 64, pp. 1298-1300.
9. Miller, R. G., Bradley, W., Cudkowicz, M., Meininger, V., Mitsumoto, H. and Sauer, D. (2005) Phase II/III controlled trial of TCH 346 in patients with amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis.6, p. 13.
10. Florence, J. M., Moore, D. H., Mendoza, M., Mass, J., Renna, R. and Malinowski, L. (2004) Validation of telephonic administration of the ALSFRS-R. Neurology, 62, p. A134.
11. Kasarskis, E. J., Dempsye-Hall, L., Luu, L. C., Mendiondo, M. and Kryscio, R. (2005) Rating the severity of ALS by caregivers over the phone using the ALSFRS-R. Amyotroph Lateral Scler Other Motor Neuron Disord, 6, pp. 50-54.
12. Kaufmann, P., Levy, G., Montes, J., Buchsbaum, R., Barsdorf, A. I. and Battista, V. (2006) Excellent inter-rater, intra-rater, and telephone-administered reliability of the ALSFRS-R in a multicenter clinical trial. Amyotroph Lateral Scler Other Motor Neuron Disord
13. Montes, J., Levy, G., Albert, S., Kaufmann, P., Buchsbaum, R. and Gordon, P. H. (2006) Development and evaluation of a self-administered version of the ALSFRS-R. Neurology, 67, pp. 1294-1296.