For the more than 37 million Americans who suffer from migraines, the FDA authorization of Click Therapeutics’ CT-132—the first prescription digital therapeutic for the preventive treatment of episodic migraine—is more than a headline. It offers the potential for expanded access, improved quality of life, and the legitimization of digital medicine as a cornerstone of care.

Rewriting the Migraine Narrative

For people living with episodic migraine—those experiencing up to 14 migraine days a month—prevention is critical. Migraine is far more than “just a headache.” It is a neurological disease that can be disabling, impacting work, relationships, and emotional well-being.

According to the American Migraine Foundation, almost 90 percent of people with migraines are unable to work or function normally during an attack. What’s more, only about 12 percent of those with migraines receive preventive treatment—a treatment gap due to side effects, fear, access barriers, or lack of awareness.

“This is where CT-132 emerges as a potential game-changer,” said Click Therapeutics Founder and CEO David Klein in an exclusive comment to Medika Life.  “We’re entering a new era of migraine care—where doctors can harness the power of both proven medicines and clinically validated digital therapeutics to meet patients’ urgent needs.”

Data That Delivers

Until recently, the FDA approved most digital health approaches under the device 510K pathway with limited clinical data.  FDA marketing authorization for CT-132 was supported by biopharma-like data from the pivotal ReMMi-D randomized controlled trial, in which CT-132 met its primary endpoint by significantly reducing monthly migraine days on top of background pharmacotherapy,

In the bridging study, ReMMiD-C, CT-132 showed similar performance in patients on prescription calcitonin gene-related peptide (CGRP) inhibitors such as Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Vyepti (eptinezumab), Ubrelvy (ubrogepant), Nurtec ODT (rimegepant), and Qulipta (atogepant).  CT-132 is an adjunctive treatment to medication, giving it broad potential use.

CT-132, delivered via a mobile app, achieved statistically and clinically meaningful results in the ReMMi-D pivotal trial. Participants who used the digital therapeutic reported a mean reduction of 3.04 monthly migraine days, compared to just 0.9 days in the sham group (p=0.005). That means real days—at work, with family, outside in the sun—returned to people’s lives.

In a condition where every single migraine-free day matters, the ability to deliver those gains without pharmacological side effects through a smartphone app democratizes access to care. It opens the door to new options, particularly for those who cannot tolerate or access traditional therapies.

“This marks a significant milestone for the more than 37 million adults in the US who live with migraine,” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “CT-132 offers eligible patients a new path to reducing the burden caused by migraine—one they can access anywhere via an evidence-based mobile application on their smartphone.”

Digital Care, Doctor-Led

Importantly, CT-132 does not sideline clinicians—it includes them as front-and-center leaders in care delivery. As a prescription-only digital therapeutic, CT-132 is designed to be used under the guidance of a health provider, adding a new clinical approach to physician-directed personalized care. It enhances—not replaces—traditional physician-patient relationships by enabling clinically validated, behavior-based treatment delivered consistently between visits.

Neurologists and primary care providers who manage migraines now have an evidence-based, non-drug adjustive approach to care, especially to patients who have tried multiple therapies and continue to have breakthrough episodes.

Data is the Gatekeeper

The approval also signals a broader truth long-awaited in digital health: evidence is everything. As digital therapeutics gain traction, the FDA and the medical community are asking for the same rigor as traditional pharmaceuticals.

“For digital health ventures to gain the confidence of regulators, providers, and patients, clinical validation must be central,” said Julien de Salaberry, CEO of Galen Growth. “This approval is a reminder that digital therapeutics can meet gold-standard evidence expectations—and that’s how they earn a place in modern medicine.”

[See Medika Life special report: Consumer HealthTech: A Data-Driven Evolution in Health Engagement]

According to Galen Growth analytics, only 24 percent of digital health companies globally have demonstrated clinical strength through trials or peer-reviewed publications. CT-132 stands out and sets the bar. Generating clinical evidence in digital health has become a marker for success. Galien Growth recently published its landmark analysis of digital health and consumer use, which includes the importance of data for product and category progress.

A Future Forward

The approval of CT-132 reflects a movement in medicine, reimagining how we define treatment, access, and wellness. It’s a reminder that innovation is not just about what is possible, more importantly, what is proven. As more digital therapeutics enter the pipeline, the CT-132 journey offers a case study of what it takes to cross the threshold from hope to health reality.

This approval to market brings something invaluable to people with migraines: urgency. The ability to be treated anywhere, on their terms, using science-backed interventions, gives people not just fewer migraines but more voice in their care.

This is not just a regulatory milestone. It’s a human one.

[This article is not sponsored or requested by any company. The author has been covering digital health since 1995 and seeks to highlight sector trends. He maintains editorial independence.]

The post A Digital Turning Point in Migraine Care: CT-132 FDA Approval to Market is a Win for Patients and Proof that Clinical Evidence Matters appeared first on Medika Life.

All recognized psychiatric or neurologic syndromes are cataloged in both of these publications, yet there is no inclusion for that syndrome (although others may also exist without mention) that is extremely disturbing to anyone experiencing it: Alice in Wonderland syndrome.

As in Lewis Carroll’s well-known book Alice’s Adventures in Wonderland, the world becomes warped during bouts of the syndrome. Time can go faster or slower, colors lighten or darken, and bodies change shape.

One young patient described an incident: Her legs would grow to meet the distant wall, which seemed to go on forever; eventually, she would reach out and touch the door with her little toe. She appeared floating in the corner the whole time, staring at her warped figure.

Besides these symptoms, depersonalization or derealization is a common symptom that accompanies them. Causes of these distortions include migraines, epilepsy, brain injuries, medications, and infections; their duration can range from minutes to days.

Although the actual diagnosis is unusual (less than 200 documented clinical instances have been noted since 1955, mainly affecting youngsters), symptoms similar to Alice’s seem relatively common. A 1999 survey indicated that 30% of people had encountered some form of visual distortion at some point. Additionally, a recent study found that approximately 16% of migraine sufferers also experienced Alice in Wonderland syndrome symptoms on and off throughout their lives.

Dots appear continuously and relentlessly across the whole visual field in people with visual snow syndrome, much like an analog TV with the programming all wrong. Childhood symptoms are seen in 40% of instances. For fear of being stigmatized as having a mental illness, people with AIWS, particularly children, are hesitant to discuss their symptoms. Hence, it is possible that this disruption is undervalued. Although there are various theories regarding their origin, the visual symptoms of migraine remain a pathophysiologic mystery, despite their prevalence.

Migraine Sufferers

Of 808 migraine patients, 133 individuals (16.5%, mean age 44.4 ± 13.3 years, 87% women) reported AIWS symptoms throughout their lives. Telopsia (72.9%) was one of the most frequent, followed by micro- and/or macrosomatognosia (49.6%), and macro- and/or pelopsia (38.3%), lasting on average half an hour. AIWS symptoms occurred in association with headache in 65.1% of individuals, and 53.7% had their first AIWS episode at the age of 18 years or earlier. Migraine patients with aura were more likely to report AIWS symptoms than those without aura.

Predominance of the female sex begins during puberty, and the number of children and adolescents affected by pediatric migraine rises with age from 7.7 to 17.8 percent. In about 1.6% of children who suffer from migraines, there is a predominance of brief neurological symptoms called aura. Aura is primarily manifested visually in 63% of cases.

The visual aura has been extensively studied in both children and adults, and its manifestations can be rather diverse. The studies, however, have not come to a definitive set of criteria that could be included in the textbook outlining psychiatric or neurological disorders.

Why has the healthcare, specifically those in neurology or psychiatry, paid little attention to this syndrome? The fact that AIWS is typically only transient is one reason why there is a dearth of research on the topic. The impact of AIWS is temporary because the underlying causes are often transient as well.

The precise diagnostic criteria and symptoms of the illness are also a matter of debate among experts. Healthcare providers typically rely on their professional judgment when deciding to diagnose AIWS, as there are no currently approved criteria. Experts feel that this illness is frequently under- or overdiagnosed due to all these reasons.

So, how do we diagnose a syndrome for which there are no specific criteria? It appears to be a matter of individual discretion, and therein lies the problem. If too few patients who truly do have this syndrome are being underdiagnosed, then they are being under-treated.

There should be a mandate within medicine to do more regarding the syndrome to provide effective treatments for patients with it. Failing to do this is a failure for patients in need. Is no one providing funding for this research? Of course, according to current statistics, which appeared to be flawed because of the fluctuating criteria by individuals, it would appear to be a rare syndrome.

Proceeding with such flimsy statistics is unprofessional and must be addressed. The Dark Ages weren’t limited to the Middle Ages, apparently.

Learn how Lewis Carroll wrote Alice in Wonderland with this video. There is some speculation that Carol may either have been suffering migraines of his own or may have been under the influence of drugs when he wrote some of his stories.

The post Curiouser and Curiouser Found in Alice in Wonderland Syndrome appeared first on Medika Life.

If she does not get medicine on board immediately with symptom onset, days of misery ensue.

Migraine is a debilitating neurological disease that affects over a billion people worldwide, with those assigned female at birth significantly more likely to experience it than men (21 versus 10 percent).

This common condition often hits young people the hardest, leading to missed days at work and school, reduced productivity, increased errors, and presenteeism (being present but not fully functioning due to illness).

Today, I’ll briefly explore a new nasal spray for those suffering from migraines.]

Background

Migraines can knock someone out of commission.

Symptoms such as nausea, pain, and light sensitivity can render it impossible to work or care for family members.

Migraine is the leading cause of disability among women.

Many people suffered migraines, including Julius Caesar, St. Paul, Thomas Jefferson, and Charles Darwin.

My friend is one of many searching for better migraine management options.

First, I cannot resist looking at the historical record.

A Brief History of Migraines

The ancient Egyptians described migraines and nerve pain.

Hippocrates (460–370 BC), the father of medicine, was the first to document migraine scientifically.

“A bright light in the right eye, followed by the onset of severe pain in the head, which eventually extended to the entire area.”

Let’s turn to the breakthrough.

A Nasal Spray for Migraines: Timolol

There are many migraine medications, but they sometimes are not very effective, have high costs, or associated side effects.

Migliazzo and Hagan published the first case series of long-term success in treating acute migraines with timolol eye drops.

Timolol eye drops bypass the digestive process when applied to healthy eyes.

They rapidly travel through the tear ducts to the nasal passages, where absorption by the nasal mucosa rivals the speed of intravenous injection.

A nasal spray makes sense since the mechanism of action is through the nose (and some have trouble using eye drops).

Nasal Spray Study

Researchers had a national compounding pharmacy create a nasal spray device to deliver Timolol.

Patients spray each nostril quickly at the first onset of headache.

If symptoms persist, they can repeat the spar 10 to 15 minutes later, with a maximum number of sprays found in 24 hours.

No one on beta-blocker medicines was offered the spray.

Nasal Spray Results

Here are the results of a small series of 16 patients with refractory migraines:

Ten patients (63 percent) reported being pleased with the nasal Timolol and added it to their preferred treatment.

There were no significant side effects.

My Take

A National Headache Foundation survey indicates that the majority of individuals with migraine are unable to control their disease and are dissatisfied with current preventive treatment options.

We must do better.

The reported series on nasal timolol is remarkably small.

Concerning safety, Timolol has been approved for glaucoma, many cardiovascular conditions, and migraines for over 40 years, and it has a long track record of safety.

If you have acute migraine headaches that are not responding satisfactorily to standard medicines, nasal spray timolol 0.5% may offer you another option.

Finally, the study authors offer this:

“A huge advantage of this treatment is that it is presently available from O’Brien Pharmacy in Kansas City and Bayview Pharmacy in Rhode Island by prescription. The formulation has been published in the International Journal of Pharmacy Compounding, so other local compounding pharmacies should be able to prepare it.”

The study authors indicate they have no financial conflicts.

The post New Hope for Migraine Sufferers: Could a Simple Nasal Spray Be the Answer? appeared first on Medika Life.

I find this concept helpful for understanding and healing from chronic pain and other stress-related symptoms, but I want to propose an additional layer of nuance.

Fear, like pain, is something that we need for survival. Without fear, we wouldn’t run for cover when a tornado is coming. Without pain, we wouldn’t pull our hand away from the stove when we get burned.

So, it wouldn’t be accurate to say that all fear is undesirable or that all fear leads to chronic pain. And it’s certainly impossible to get rid of fear or to never feel afraid again.

But there’s one type of fear in particular that I find most often in clients who struggle with chronic symptoms, and that is the fear of social rejection. This fear can trigger self-abandoning thoughts and behaviors, and habitual self-abandonment leaves us feeling helpless and hopeless. It can put our nervous system into a state of chronic stress that manifests in chronic symptoms.

Here are some anecdotal examples:

I’ve seen folks who are afraid to sit, stand or walk because it hurts, and the more they fear these activities, the more the pain persists. But what really escalates their pain levels is the fear that they will be rejected by their family, their job, their partner and friends for not being able to “keep up.” This social fear preoccupies them so greatly that they spend most of their energy trying to please others rather than prioritizing their own feelings, needs, desires and pleasures. And this habit of self-abandonment puts them in a chronic state of stress.

I’ve seen folks who are afraid to go out for a night on the town for fear that it will trigger a migraine attack. And the more they fear and predict pain, the more the pain persists. But what really escalates their attacks is the fear that friends and loved ones will see them as weak or pathetic or uncool for not being able to “keep up.” And again, it’s that social pressure that triggers self-abandoning habits which in turn leads their body to feel like it can’t trust them. And when our body feels like it can’t trust us, it freaks out and pulls the emergency alarm: symptoms.

If any of this is resonating with you, you might be wondering: OK now what? Now that I’ve recognized this pattern of fear of rejection and self-abandonment that exacerbates my stress levels and symptoms, what the heck can I do about it?

And my answer might not be what you want to hear, because when we’re feeling fearful, we want quick solutions and certainty. And as far as I know, the antidote to self-abandonment is something far more complex than that: it’s the gradual journey of developing self-compassion.

Developing self-compassion is slow work. It’s gentle work. It’s asking ourse in each moment, “what is the simplest, easiest, most doable step I can take right now to be just a little bit gentler and kinder toward myself?”

We can’t develop self-compassion with harsh expectations or by pressuring ourselves to transform our self-relationship overnight. We have to give ourselves the grace to do it one baby step at a time.

So, keep it simple and ask yourself, “what is the simplest, easiest doable step I can take — from exactly where I am right now — to bring just a tiny bit more kindness and gentleness into the way I treat myself?”

I’d love to hear what you come up with!

➡️ If you need support with chronic pain and anxiety, take my FREE QUIZ called “Why the *bleep* am I still in pain?!” so I can help you get some clarity.

And follow me on Instagram for healing tips, inspiration and encouragement.

The post The Role of Fear and Self-Abandonment in Chronic Symptoms appeared first on Medika Life.