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A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS): the statistical analysis plan of TUDCA-ALS trial.

Author: , AlbaneseAlberto, CiprianiMarta, CorciaPhilippe, DickieBrian, HardimanOrla, Lo GiudiceMaria, LombardoFlavia L, LudolphAlbert Christian, MayerFlavia, McDermottChristopher J, NicoliniGabriele, PuopoloMaria, Spila AlegianiStefania, Van DammePhilip, Van den BergLeonard H, VanacoreNicola

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Overview

Amyotrophic lateral sclerosis (ALS) is a serious and debilitating brain disease with no cure. While a medication called riluzole can slow down the progression of ALS and slightly extend lifespan, we need new treatments. A medication called tauroursodeoxycholic acid (TUDCA) shows promise as a potential treatment for ALS due to its ability to protect nerve cells.
Paper Details　
Original Abstract of the Article :
Amyotrophic lateral sclerosis (ALS) is a highly debilitating neurodegenerative condition. Despite recent advancements in understanding the molecular mechanisms underlying ALS, there have been no significant improvements in therapeutic options for ALS patients in recent years. Currently, there is no ...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10696667/

データ提供：米国国立医学図書館（NLM）

Tauroursodeoxycholic Acid (TUDCA) as an Add-on Treatment for Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disease with limited treatment options. This research explores the potential of tauroursodeoxycholic acid (TUDCA) as an add-on treatment for ALS patients. The study investigates the safety and efficacy of TUDCA in conjunction with riluzole, the only currently approved treatment for ALS in Europe. The study is designed as a randomized double-blind clinical trial to evaluate the impact of TUDCA on disease progression and overall survival in ALS patients. The study leverages the promise of TUDCA's neuroprotective properties to potentially improve the lives of ALS patients.

The Potential of Tauroursodeoxycholic Acid (TUDCA) in Treating Amyotrophic Lateral Sclerosis (ALS)

The research highlights the potential of TUDCA as a promising treatment for ALS. The study's design and focus on the neuroprotective effects of TUDCA suggest that this drug could potentially slow disease progression and improve overall survival for ALS patients. The study's findings, once available, could significantly impact the management of ALS and provide much-needed hope for patients facing this debilitating disease.

Finding Hope for Amyotrophic Lateral Sclerosis (ALS) Patients

The research offers hope for ALS patients and their families. While ALS remains a complex and challenging condition, the exploration of new treatment options like TUDCA represents a significant step forward in the search for more effective therapies.

Dr. Camel's Conclusion

This research is a testament to the ongoing pursuit of innovative treatments for ALS. The exploration of TUDCA as a potential add-on therapy holds immense promise for improving patient outcomes and offering a beacon of hope for those affected by this devastating disease. It's like discovering a hidden oasis in a vast desert, providing much-needed relief for those suffering from this debilitating condition.

Date :
  1. Date Completed 2023-12-07
  2. Date Revised 2023-12-08
Further Info :

Pubmed ID

38053196

DOI: Digital Object Identifier

PMC10696667

SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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