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Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Clinical Trials

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

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Related Experiment Video

Updated: Aug 6, 2025

Ultrasound-guided Botulinum Toxin-A Injections: A Method of Treating Sialorrhea

Ultrasound-guided Botulinum Toxin-A Injections: A Method of Treating Sialorrhea

Published on: November 9, 2016

BoNT clinical trial update: Sialorrhea.

Emily T Tamadonfar¹, Mark F Lew¹

¹Division of Movement Disorders, Department of Neurology, Keck/University of Southern California School of Medicine, Los Angeles, CA, USA.

Toxicon : Official Journal of the International Society on Toxinology

|March 17, 2023

Summary

Sialorrhea, or excessive saliva, is common in neurologic diseases. Botulinum toxin injections are a leading treatment, with recent trials showing effectiveness in reducing salivary flow and improving outcomes.

Keywords:

Botulinum toxin Movement disorders Parkinson's disease Sialorrhea Xerostomia

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Last Updated: Aug 6, 2025

Ultrasound-guided Botulinum Toxin-A Injections: A Method of Treating Sialorrhea

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Published on: November 9, 2016

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Area of Science:

Neurology
Gastroenterology
Otolaryngology

Background:

Sialorrhea, characterized by excessive saliva accumulation, frequently affects patients with various neurologic conditions.
Management strategies have evolved, encompassing nonpharmacologic, pharmacologic, and surgical interventions.
Botulinum toxin injections have emerged as a primary therapeutic option for sialorrhea.

Approach:

This review examines the historical progression of sialorrhea management and injection techniques.
It critically analyzes the challenges inherent in evaluating and quantifying treatment efficacy in clinical trials.
Contemporary randomized controlled trials of incobotulinumtoxin and rimabotulinumtoxin for sialorrhea are compared.

Key Points:

Recent large-scale randomized controlled trials, including incobotulinumtoxin (2019) and rimabotulinumtoxin (2020), demonstrate significant reductions in salivary flow rate.
These trials report consistent improvements in clinical outcomes with comparable treatment durations.
Botulinum toxin offers a well-established and effective treatment modality for managing sialorrhea.

Conclusions:

Botulinum toxin injections represent a cornerstone in the contemporary management of sialorrhea across diverse neurologic disorders.
Ongoing research and clinical trials continue to refine our understanding of optimal dosing and injection strategies.
Effective management of sialorrhea significantly enhances patient quality of life.