determining-pain-detection-tolerance-thresholds-using-an-integrated

Determining Pain Detection and Tolerance Thresholds Using an Integrated, Multi-Modal Pain Task Battery

Human pain models are useful in the assessing the analgesic effect of drugs, providing information about a drug&#39;s pharmacology and identify ...

a-computerized-test-battery-to-study-pharmacodynamic-effects-on

A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development

Investigating potential pharmacodynamic effects in an early phase of central nervous system (CNS) drug research can provide valuable information for ...

Centre for Human Drug Research (CHDR)

Centre for Human Drug Research (CHDR), Leiden

The objective of this paper is to discuss the sequential trial design and its advantages in clinical trials for ALS. The sequential trial design is an alternative to the classical trial design, which permits stopping a study as soon as a treatment effect can be significantly demonstrated or denied.

Sequential designs for clinical trials in amyotrophic lateral sclerosis.

A sequential trial design is an alternative for the classical trial design with a fixed sample size, that permits stopping a trial as soon as enough evidence for a treatment effect, or a lack thereof, is obtained. This study aimed to determine the difference in efficiency of time and patient number between a classical trial design and a sequential trial design. In this study we re-analysed a previously published classically designed clinical trial according to a sequential trial design. We subsequently determined the difference in total running time and patient number. We found that the sequential analysis offered a gain in time of 38%. We conclude that the sequential trial design may in certain situations be superior to the classical design.

Alternative trial design in amyotrophic lateral sclerosis saves time and patients.

To determine whether valproic acid (VPA), a histone deacetylase inhibitor that showed antioxidative and antiapoptotic properties and reduced glutamate toxicity in preclinical studies, is safe and effective in amyotrophic lateral sclerosis (ALS) using a sequential trial design.

Randomized sequential trial of valproic acid in amyotrophic lateral sclerosis.

Pompe's disease is a metabolic myopathy caused by a deficiency of acid alpha glucosidase (GAA), an enzyme that degrades lysosomal glycogen. Late-onset Pompe's disease is characterized by progressive muscle weakness and loss of respiratory function, leading to early death. We conducted a randomized, placebo-controlled trial of alglucosidase alfa, a recombinant human GAA, for the treatment of late-onset Pompe's disease.

A randomized study of alglucosidase alfa in late-onset Pompe's disease.

Integrating opioid risk and benefit into a single function may give a useful single measure of the opioid's positive and negative effects. An explorative study on the effects of fentanyl on antinociception and respiratory depression was performed to construct fentanyl risk-benefit (utility) functions.

ArticleTotal : 2	Year
Publication title Cited by 17	2016
Publication title Cited by 4	2019

Article	Year
Sequential designs for clinical trials in amyotrophic lateral sclerosis. Amyotrophic lateral sclerosis and other motor neuron disorders : official publication of the World Federation of Neurology, Research Group on Motor Neuron Diseases\| PubMed ID: 15799547	2004
Alternative trial design in amyotrophic lateral sclerosis saves time and patients. Amyotrophic lateral sclerosis : official publication of the World Federation of Neurology Research Group on Motor Neuron Diseases\| PubMed ID: 17852016	2007
Randomized sequential trial of valproic acid in amyotrophic lateral sclerosis. Annals of neurology\| PubMed ID: 19743466	2009
A randomized study of alglucosidase alfa in late-onset Pompe's disease. The New England journal of medicine\| PubMed ID: 20393176	2010
Fentanyl utility function: a risk-benefit composite of pain relief and breathing responses. Anesthesiology\| PubMed ID: 23756452	2013

Geert Jan Groeneveld

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