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Phase II screening trial of lithium carbonate in amyotrophic lateral sclerosis: examining a more efficient trial design.

Abstract：

OBJECTIVE:To use a historical placebo control design to determine whether lithium carbonate slows progression of amyotrophic lateral sclerosis (ALS). METHODS:A phase II trial was conducted at 10 sites in the Western ALS Study Group using similar dosages (300-450 mg/day), target blood levels (0.3-0.8 mEq/L), outcome measures, and trial duration (13 months) as the positive trial. However, taking riluzole was not a requirement for study entry. Placebo outcomes in patients matched for baseline features from a large database of recent clinical trials, showing stable rates of decline over the past 9 years, were used as historical controls. RESULTS:The mean rate of decline of the ALS Functional Rating Scale-Revised was greater in 107 patients taking lithium carbonate (-1.20/month, 95% confidence interval [CI] -1.41 to -0.98) than that in 249 control patients (-1.01/month, 95% CI -1.11 to -0.92, p = 0.04). There were no differences in secondary outcome measures (forced vital capacity, time to failure, and quality of life), but there were more adverse events in the treated group. CONCLUSIONS:The lack of therapeutic benefit and safety concerns, taken together with similar results from 2 other recent trials, weighs against the use of lithium carbonate in patients with ALS. The absence of drift over time and the availability of a large database of patients for selecting a matched historical control group suggest that use of historical controls may result in more efficient phase II trials for screening putative ALS therapeutic agents. CLASSIFICATION OF EVIDENCE:This study provided Class IV evidence that lithium carbonate does not slow the rate of decline of function in patients with ALS over 13 months.

journal_name

Neurology

journal_title

Neurology

authors

Miller RG,Moore DH,Forshew DA,Katz JS,Barohn RJ,Valan M,Bromberg MB,Goslin KL,Graves MC,McCluskey LF,McVey AL,Mozaffar T,Florence JM,Pestronk A,Ross M,Simpson EP,Appel SH,WALS Study Group.

doi

10.1212/WNL.0b013e31822dc7a5

subject

Has Abstract

pub_date

2011-09-06 00:00:00

pages

973-9

issue

10

eissn

0028-3878

issn

1526-632X

pii

WNL.0b013e31822dc7a5

journal_volume

77

pub_type

杂志文章,多中心研究

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