Download our whitepaper,
ALS Clinical Trials: Diagnostic
Criteria and Development Trends
What's Inside:
- Overview of ALS pathophysiology and diagnostic approaches.
- Biomarkers for disease progression and prognosis.
- Endpoints: survival, functional rating scales, and quality of life.
- Emerging gene therapy and antisense oligonucleotide approaches.
- Adaptive and platform trial designs in ALS research.
- Strategies to overcome recruitment and retention challenges.
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ALS Clinical Trials
Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disorder that primarily attacks motor neurons in the brain and the spinal cord. The disease leads to the gradual deterioration and eventual death of motor neurons, which are crucial for controlling voluntary muscles.
Navigating the regulatory landscape is critical for the success of clinical trials in ALS. The US FDA sets stringent standards to ensure that new treatments are safe and effective. Understanding these regulatory requirements and implementing strategies to meet them are essential steps in the development and approval process of new ALS treatments.
40–70
ALS is most commonly diagnosed between the ages of 40 and 70
2%
ALS accounts for approximately 2% of all neurodegenerative disorders globally
5 in 100,000
ALS affects approximately 5 in 100,000 people worldwide annually
Our clinical team has over
120
years of combined clinical trial experience