Headache Disorders

Capture accurate, timely patient-reported outcomes

Pain’s subjective nature leads to variability in clinical outcome reporting and treatment response, especially in headache trials where primary endpoints depend on daily PRO diaries for tracking pain intensity, frequency, and rescue medication use. 

How we help:

• We offer validated eDiaries with built-in reminders and time-stamping features to ensure real-time, accurate reporting
• PIN-protected entries ensure data that is attributable, legible, and compliant with FDA ALCOA standards
• Our flexible solutions and accessible interfaces are specifically designed to enhance patient adherence and streamline your headache trials

Reduce placebo response to protect your endpoint

High placebo response rates pose a common challenge and often lead to the failure of headache trials by diluting the treatment effect.

We address this with:

• Neuroscientist-developed placebo mitigation scripts and interactive investigator training
• Proven strategies are deployed throughout the study lifecycle
• Real-world success in migraine studies using our effective mitigation protocols

Transform imaging challenges into reliable results

In headache and migraine trials, imaging helps identify key CNS biomarkers – but without standardization and expert review, data variability can compromise reliability and delay development progress.

How we help:

• Implement centralized MRI protocols tailored to headache and CNS studies
• Provide access to expert evaluation of white matter changes, vascular features, and functional connectivity
• Offering consistent, regulatory-ready data under the guidance of our neuroscientists and neuroradiologists

Cardiovascular risks add complexity to treatment evaluation

Headache and migraine treatments often require cardiac safety monitoring due to known risks like QT prolongation or blood pressure effects, adding complexity to treatment evaluation. Inconsistent ECG collection or analysis can compromise patient safety and slow down your study.

At Clario, we centralize ECG collection and interpretation with precision analysis, ensuring regulatory compliance with proven QT/QTc evaluation strategies. Our dedicated cardiac safety experts, experienced in CNS and headache trials, provide the expertise needed to safeguard patient safety and streamline your study.

Adjudicate clinical events with consistency

When trials involve investigator-reported clinical events, ensuring standardized and unbiased centralized review is essential.

We support this process with experienced neurologists and a robust adjudication platform to facilitate clinical endpoint review. Our streamlined workflows classify safety and efficacy events accurately, providing precise and centralized adjudication for cleaner endpoint data.