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Related Concept Videos

Clinical Trials01:16

Clinical Trials

11.2K
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...
11.2K
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.5K
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...
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Related Experiment Video

Updated: Apr 9, 2026

Rat Model of Widespread Cerebral Cortical Demyelination Induced by an Intracerebral Injection of Pro-Inflammatory Cytokines
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Failed, Inconclusive or Interrupted Trials in Multiple Sclerosis: 2020-2024 Update.

Vito Ag Ricigliano1, Natalia Szejko2, Valentina Camera3

  • 1Neurology Unit, GHNE Paris Saclay Hospital, Orsay, France; Université Paris-Saclay, UNIACT, Neurospin - INSERM UMR 1129, CEA, Gif-sur-Yvette, France.

Multiple Sclerosis and Related Disorders
|April 7, 2026
PubMed
Summary
This summary is machine-generated.

Many novel multiple sclerosis (MS) therapies show promise but fail clinical trials due to unmet needs in targeting neurodegeneration and repair. Challenges include efficacy, tolerability, and commercial viability for these chronic autoimmune disorder treatments.

Keywords:
Modifying Therapies, Immunomodulation, Clinical TrialsMultiple Sclerosis, Disease

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Area of Science:

  • Neuroimmunology
  • Clinical Pharmacology
  • Translational Medicine

Background:

  • Multiple sclerosis (MS) is a chronic autoimmune disease impacting millions globally.
  • Current treatments address inflammation but not neurodegeneration, progression, or remyelination.
  • Significant unmet needs persist despite therapeutic advances.

Purpose of the Study:

  • To analyze clinical trials for multiple sclerosis (MS) that failed due to negative or inconclusive results.
  • To identify trends and challenges in MS drug development between October 2019 and October 2024.
  • To understand reasons behind trial failures to guide future therapeutic strategies.

Main Methods:

  • Conducted a literature review of MEDLINE, clinical trial databases, and conference proceedings.
  • Identified and analyzed failed Phase I-III and randomized controlled trials (RCTs) based on primary endpoints.
  • Excluded studies focusing solely on secondary MS outcomes like spasticity or cognitive impairment.

Main Results:

  • 17 investigational agents across seven classes (e.g., immune-active, neuroprotective, remyelination antibodies) were identified.
  • While some agents showed biological activity (e.g., reduced MRI lesions, improved VEPs), none met primary endpoints.
  • Reasons for failure included safety concerns, heterogeneous patient populations, and insensitive endpoints.

Conclusions:

  • Novel MS therapies demonstrate mechanistic promise but face significant hurdles in achieving durable clinical outcomes.
  • Key challenges include addressing disability accumulation, ensuring drug tolerability, promoting repair, and achieving commercial viability.
  • Further research is needed to overcome these barriers and develop more effective MS treatments.