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Functional outcome measures as clinical trial endpoints in ALS

From the Neurology Clinical Trials Unit (Drs. Traynor and Cudkowicz), Department of Neurology, Massachusetts General Hospital, Boston, MA; Biostatistical Center (Drs. Zhang and Schoenfeld), Department of Medicine, Massachusetts General Hospital, Boston, MA; Department of Neurology (Dr. Shefner), Upstate Medical University, Syracuse, NY; and Clinical Investigator Training Program (Dr. Traynor), Harvard/MIT Health Sciences and Technology–Beth Israel Deaconess Medical Center, Boston, MA.

Address correspondence and reprint requests to Dr. Bryan J. Traynor, Massachusetts General Hospital–East, Day Laboratory for Neuromuscular Research, Building 114, Room 3125, 16th Street, Charlestown, MA 02129; e-mail: btraynor{at}partners.org

The topiramate study was a 12-month randomized placebo-controlled trial in patients with ALS. Follow-up evaluation of the placebo group (n = 97) constituted a well-described cohort of patients with ALS, in whom multiple outcome measures were assessed at 3-month intervals. During the 12-month study period, the decline of forced vital capacity (FVC%) and ALS functional rating scale (ALSFRS) was linear, whereas the decline of maximum voluntary isometric contraction–arm (MVIC-arm) and MVIC-grip Z scores was curvilinear. Rates of FVC% and ALFRS decline, but not of MVIC-arm or MVIC-grip, were independent predictors of survival.

Received February 3, 2004. Accepted in final form July 29, 2004.

Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the November 23 issue to find the link to this article.

See Commentary, page 1765

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November 23 Highlight and Commentary
Neurology 2004 63: 1765. [Full Text] [PDF]

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