Migraine is one of the most common and widespread chronic neurological disorders. It is characterized by recurring headache attacks that can be severe and are often accompanied by neurological symptoms such as nausea, sensitivity to light (photophobia) or sound (phonophobia), and visual disturbances known as “aura” in some cases.
Migraine is classified into two main types:
1. Migraine with aura: Accompanied by temporary neurological symptoms that precede the headache attack, such as light flashes, visual distortions, or numbness.
2. Migraine without aura: The more common form, usually beginning with a throbbing headache on one side of the head.
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CT-132: The First FDA-Approved Digital Treatment for Migraine
In April 2025, the U.S. Food and Drug Administration (FDA) approved the first prescription digital therapeutic for the prevention of episodic migraine, known as CT 132. This is a therapeutic smartphone app that is available by prescription.
How CT-132 Works
CT-132 was developed using Cognitive Behavioral Therapy (CBT) techniques. It aims to reduce central sensitization in the brain and works through daily lessons, a digital symptom diary (e-Diary), and guided pain-behavior exercises.
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Effectiveness of the Treatment
According to the ReMMi-D clinical trial, which involved over 500 patients with episodic migraine, results showed:
• A reduction in the number of headache days by an average of 3 days.
• Improvements in quality of life measures (MSQ) and the Migraine Disability Assessment (MIDAS).
• High patient adherence and a favorable safety profile with no serious side effects.
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Conclusion
The trial concluded that CT-132 plays a promising role in the future of migraine treatment. It is used as an adjunct to pharmacological therapies and offers an effective alternative, especially for patients who do not respond to traditional treatments. It provides a modern, evidence-based, behavioral approach and empowers patients to take an active role in their treatment plan.
The approval of CT-132 reflects a shift in neurological medicine toward integrating digital technology. It is a promising option that enhances self-care and reduces dependence on medications.
Source:
https://www.medscape.com/viewarticle/fda-authorizes-first-prescription-digital-therapeutic-2025a1000993

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