PMID: 9436727Jan 22, 1998Paper

Exploratory treatment trials in multiple sclerosis using MRI: sample size calculations for relapsing-remitting and secondary progressive subgroups using placebo controlled parallel groups

Journal of Neurology, Neurosurgery, and Psychiatry
N TubridyD H Miller

Abstract

Serial brain MRI is widely used in pilot studies of new agents to monitor treatment efficacy in relapsing-remitting (RR) and secondary progressive (SP) multiple sclerosis (MS). For pilot trials, sample size calculations for the RR subgroup are based on the data from small numbers of patients and separate calculations for the SP subgroup have not been performed. The present study considers these issues. The sample size calculations were based on data from six months of monthly T2 weighted and gadolinium enhanced MRI in 31 RR and 28 SP untreated patients undergoing natural history studies or in the placebo arm of a therapeutic trial. The calculations were for a placebo controlled, parallel groups design lasting six months. The sample sizes were based on bootstrap analysis with an 80% likelihood of showing a given treatment effect. With a single pretreatment scan, demonstration of a 70% reduction in newly active lesions required 2x30 RR and 2x50 SP patients. With an extra run-in scan one month before treatment, the sample sizes were 2x20 for RR and 2x30 for SP patients. The sample sizes required for RR patients were comparable with previous smaller studies. Larger sample sizes were needed for the SP group, but the extra run in sca...Continue Reading

References

Jun 1, 1992·Journal of Neurology, Neurosurgery, and Psychiatry·D H MillerW I McDonald
Oct 1, 1988·Radiology·R I GrossmanF Gonzalez-Scarano
Mar 1, 1983·Annals of Neurology·C M PoserW W Tourtellotte
Feb 1, 1993·Brain : a Journal of Neurology·B Runmarker, O Andersen
Jan 1, 1996·Journal of Neurology, Neurosurgery, and Psychiatry·D KiddA J Thompson
Sep 1, 1996·Annals of Neurology·R RudickE Willoughby

❮ Previous
Next ❯

Citations

Dec 3, 1999·Journal of the Neurological Sciences·R A SaterS J Bird
Dec 22, 1999·Journal of the Neurological Sciences·M Rovaris, M Filippi
Jul 20, 2002·Clinical Neurology and Neurosurgery·David H Miller
Dec 22, 1999·Philosophical Transactions of the Royal Society of London. Series B, Biological Sciences·D H Miller, A J Thompson
Apr 14, 1999·Journal of Neurology, Neurosurgery, and Psychiatry·M P SormaniM Filippi
Mar 20, 2001·Journal of Neurology, Neurosurgery, and Psychiatry·M P SormaniM Filippi
Feb 18, 2005·NeuroRx : the Journal of the American Society for Experimental NeuroTherapeutics·David H Miller
Feb 4, 2010·Pharmacology & Therapeutics·Anneke Van der WaltTrevor Kilpatrick
Sep 18, 2009·Journal of the Neurological Sciences·S VukusicUNKNOWN Prevention of Post-Partum Relapses with Progestin and Estradiol in Multiple Sclerosis Study Group
Jan 30, 2009·Computational Statistics & Data Analysis·Inmaculada B AbanNsoki Mavinga
Oct 4, 2011·Statistics in Medicine·Rachel MacKay AltmanAlex Smith
Oct 8, 2005·Journal of the Neurological Sciences·Carla TortorellaMaria Trojano
Nov 29, 2001·Multiple Sclerosis : Clinical and Laboratory Research·M P SormanM Filipp
Nov 7, 2000·Multiple Sclerosis : Clinical and Laboratory Research·M Filippi
Apr 13, 2012·Multiple Sclerosis : Clinical and Laboratory Research·R M AltmanA Smith
Jun 22, 2017·Statistical Methods in Medical Research·Thomas AsendorfTim Friede

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.