Scientific Progress for Patients and a Category

At the core of the ReMMi-D trial was the evaluation of CT-132, a prescription digital therapeutic, for the preventive treatment of episodic migraine. The study included 568 participants and was designed with the scientific rigor traditionally associated with pharmacological interventions. The results were compelling: patients using CT-132 experienced a reduction during three-monthly migraine days by the end of the 12-week treatment, a key metric in migraine management.

More than reducing the frequency of migraines, CT-132 showed improvements in patient-reported outcomes related to quality of life and disability, such as the Migraine-Specific Quality-of-Life Questionnaire and the Migraine Disability Assessment. These metrics matter because migraine is a neurological condition that disrupts life activities, affecting employment and social relationships. For the millions of people who have unpredictable and disabling migraines, improvement can have profound quality of life.

According to a statement by Shaheen Lakhan, MD, PhD, FAAN, chief medical officer of Click Therapeutics:“Click has developed and evaluated a first-in-class digital migraine preventive therapeutic, CT-132, in 2 separate clinical studies to demonstrate a reduction in monthly migraine days, the gold standard measure. We look forward to advancing our FDA Breakthrough Designated asset through regulatory clearance and, if successful, offering a new therapeutic option that can be delivered to any eligible patient with a smartphone, meaningfully enhancing access to care.”

Building on Existing Treatment Possibilities

Migraine remains one of the most debilitating neurological conditions, affecting more than 37 million Americans. Despite pharmacological treatment advances, many people still find their lives shaped by frequent, unexpected, debilitating episodes. Existing medications can be effective, yet they don’t work for everyone and at every instance.  Some patients struggle with adherence, side effects, or simply the anxiety around consistent relief.

CT-132 holds the potential for a new kind of intervention. Delivered by a smartphone, this digital therapeutic is designed to work alongside patients’ existing medications, augmenting their current treatments rather than replacing them. Notably, the trial was designed to evaluate CT-132 in patients already using standard migraine medications. Data from the trial points to the efficacy of CT-132 as a stand-alone intervention and suggests an additive benefit when combined with existing FDA-approved pharmacological treatments.

This approach is key to conditions like migraine, where no single treatment is universally effective. For many people, managing migraine calls for a combination of therapies—some interventional, others pharmacological, and still some behavioral. CT-132’s success demonstrates that digital therapeutics have the potential to be additive to that combination, helping people regain control over their condition.

A Potential Step Forward for Digital Health

The results of this trial are even more noteworthy for an entire sector because CT-132 is one of the first digital therapeutics to be evaluated with the same rigorous standards typically applied to pharmaceutical interventions. The randomized, double-masked, controlled study design is a gold standard in clinical research, and Click Therapeutics has brought that level of precision to the digital health category.

Stan Kachnowski, PhD, MPA, founder of HITLAB and a prominent figure in health informatics, has also echoed the importance of this transformation, stating previously that “The convergence of digital therapeutics and traditional healthcare is one of the most promising avenues for improving patient outcomes. Clinical data helps substantiate the effectiveness of digital interventions, paving the way for broader adoption in complex diseases like migraine.”

Digital health has often been touted for its innovation and potential, but the field has faced great skepticism around its ability to deliver scientifically proven results. The CT-132 trial is an answer to those on the sidelines, demonstrating how digital therapeutics—with ample clinical data—can improve people’s outcomes. The nearly 100% completion rate of daily tasks in the trial speaks to the potential for sustained patient engagement, an essential factor in the long-term success of any therapeutic intervention.

Recent FDA guidance on Prescription Drug Use-Related Software (PDURS) opens the door to a new treatment category combining digital and pharmacological interventions. The data from CT-132 adds weight to this model, opening the wide door to showing how digital therapeutics can support existing treatments and may offer added measurable benefits.

What This May Mean for Consumers

The implications of this study are significant for people and physicians who treat migraines. Beyond diagnosis, migraine is more than a medical condition—its constant presence dictates when and how people can work, study, and socialize. The Click Therapeutics data suggest a new avenue of relief that is readily accessible and shows the potential to reduce the burden of migraine in daily life.

In digital health, data is key.  Julien de Salaberry, CEO and founder of Galen Growth has often emphasized: “Data is the defining difference in how we can transform digital health into a category with the same rigor and trust as traditional biopharma.” This sentiment captures the critical role that data plays in not just validating the efficacy of digital therapeutics but also in driving their adoption and integration into mainstream healthcare​.”

Moreover, the trial was designed to be used alongside existing medications, which could assist people who feel they have already exhausted their treatment options. This is important for those who experience ongoing migraine symptoms despite the use of preventive, newer migraine medications. Digital therapeutics with demonstrated data may provide an added layer of treatment that doesn’t require the introduction of more drugs or drug-related side effects.

Future of Migraine Treatment and Digital Health

This trial’s success is more than a win for Click Therapeutics—it signals what’s possible in digital health. In demonstrating that a digital intervention can demonstrate clinical outcomes in a condition as debilitating as migraine, CT-132 may have set the bar for digital therapeutics and offers private and public payers reason to become excited about the category.

As more digital therapeutics enter the clinical landscape, their ability to integrate with and enhance traditional treatments will be crucial to their success. This trial shows that digital solutions can do more than provide “feel-good” supplementary support—they can drive measurable improvement in patient health. The data are essential to showing that hype cannot be a clinical option; digital health must deliver high evidence before being considered a serious patient option.

By setting this new precedent for clinical validation, Click Therapeutics has contributed to a more significant shift in how we think about digital health. It’s not just about innovation for its own sake—it’s about how technology can change how we manage health when designed with scientific rigor and people’s needs in mind.

The post Forget Hype – Digital Therapeutic Data Show the Category Can be Held to High Clinical Standards appeared first on Medika Life.

But it also made me cry… and as a vehicle for getting in touch with my emotions, it helped me step out of an intensity spiral 🌀 that had been brewing in me for a few days — the kind of spiral that, if left unchecked, can often result in a headache for me.

Here’s a step-by-step of how I was reluctantly healed by Barbie 😅. Regardless of what you think of the doll or the movie, you might relate to parts of this story…

It started with stress… and escalated into the stress cycle

When we experience a flare-up of anxiety or any of the physical symptoms that can come with it (like pain), we often want to trace the steps back to how and why the flare-up started. “What caused it? What could I have done to avoid it?” We’re often looking for one singular thing that we did “wrong” so that we can course-correct for the future.

But most of the time, it’s not one singular thing. Stress is cumulative. And in my case on this particular occasion, I’d recently heard several heavy stories of sad news, I was (and still am) undertaking a number of home improvement projects with my partner, and a week I’d taken off for vacation wound up being subsumed in to-do’s.

These normal, everyday stresses that come with life then kicked my stress cycle into gear. For me, it looks like this: I start fixating on stress-induced thoughts. Thoughts like, “I’m not doing enough. My partner is working harder than me, so I should be doing more. I shouldn’t relax because he’s not relaxing…”

These thoughts, of course, perpetuate more stress. It becomes a cycle that escalates.

I recognized the symptoms of the stress cycle starting to brew

In the old days, I used to think self-critical thoughts were true. And I thought that I just needed to do more and be better in order to quiet those thoughts down. I still get caught up in that kind of thinking… when I’m stressed.

What I recognize now is that those thoughts themselves are a symptom of stress. And they seem very true when I’m stressed! It’s an act of will to notice them and name them as a stress symptom so that I can start making choices that will help me unwind from the stress cycle.

Another stress symptom I noticed was that it was getting harder to concentrate on work. I felt like I was pushing myself instead of feeling led by inspiration or energy. Work started to feel like a drag and I began to feel resentment towards it.

In the days before I ever experienced a migraine, I would ignore these signals that are telling me to slow down. And I still do, sometimes. But what my recovery from chronic pain has taught me is that ignoring the signals can have very unpleasant consequences — and that as hard as it is to step off the stress merry-go-round, there are immeasurable benefits to doing so before my nervous system pulls the emergency break in the form of a pain flare-up.

I didn’t do it “perfectly”

Yes, I’ve gotten much better at listening to my nervous system’s signals. But I’m not “perfect” at it! I don’t always catch the stress before it manifests in physical pain. And I did wake up with a mild headache before fully tending to the stress.

The headache — along with increasing levels of feeling jittery throughout the morning — were my nervous system’s way of sending a louder signal. One that I decided to heed.

I’d planned to spend most of the day working on my podcast. But I made an executive decision to step away from my desk, play hooky for the rest of the day… and go see the Barbie movie. I figured two hours of sparkly pink Hollywood entertainment would get my mind out of productivity overdrive and overwhelm.

Then came the guilt!

I tiptoed out of the house, feeling tremendously guilty that my husband was still glued to endless Zoom meetings for work.

I debated whether to even tell him that I was going to the movies.

I finally sent a text message to let him know… and then sat with the waves of guilt mixed with waves of relief all the way to the theater.

Lights, camera, tears

The lights went down in the movie theater, and just as I’d hoped, the magic of Hollywood glitter took my preoccupied mind into another dimension. But much to my surprise, it wasn’t just a trip to the land of distraction and fluff.

Despite my misgivings about Barbie… that dang movie got to me. And I cried! I literally wept in the theater. Funny enough, the movie touches into a lot of the themes that we talk about in chronic pain recovery: Breaking out of numbness and feeling your full range of emotions, taking off the mask of perfectionism and revealing your authentic self…

I was reluctant to be swept up in the story — but it was exactly the emotional release that I needed. And my whole mind and body felt like they were re-set and re-energized by the time the lights came up again.

Laughter and perspective

By the time I got home, all the feelings of guilt that my stress-cycle churned up had subsided. My partner was still working away when I turned the key in the door, and when he got up to greet me he said, “Where’d you go? I didn’t know you were out!”

I had to laugh at all the angst and worry I put myself through debating whether it was okay to take time for myself while he was working.

It felt good to give him a hug and tell him about my movie escapade — and I could tell he enjoyed seeing me in such a good mood.

My takeaways from this vignette? While I might not have time to run away to the movies every day, feeling guilty about slowing down to unwind is always a signal that… it’s time to slow down and unwind. In whatever way, shape or form is available to you. Even if it starts off as a guilty pleasure, making time for pleasure will guide you back home.

➡️ 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.

The post Reluctantly Healed By Barbie 😅 appeared first on Medika Life.

My story about painkillers is not a prescription. It’s simply an honest account of my story. What I hope to model is not a step-by-step how-to, because the steps that I’ve chosen may not necessarily be the steps that you choose. Instead, I hope to model self-trust. Over and over again, I’ve found self-trust to be my path to healing. That doesn’t mean I never try something that turns out poorly and then switch gears. In fact, allowing myself to pivot when needed is an essential part of self-trust! As you’ll see in this story…

Chapter 1: The Beginning

I got my first migraine in 2007, on the first day of my very first job as a video editor on a reality TV show. That was also the first time I can remember taking a pill for a headache. I stumbled out of the office to a drugstore, searched the painkiller isle and chose “Excedrin Migraine.” The description on the bottle seemed to match what I was experiencing. Thankfully, it worked — the torturous feeling in my head dissolved into a slight euphoria and I was able to return to work and keep my job. I didn’t think too much of it.

Chapter 2: Prescription

Migraines popped up occasionally as I continued my new, high-pressure career in television. They were rare though, and I would just take Excedrin to make them go away. It was years before the migraines became frequent enough that I brought it up with a doctor. I was sent to a neurologist who prescribed Sumatriptan (also known as Imitrex) — a common migraine “emergency medication” (meaning, take as-needed, not on a daily basis.) Sumatriptan, I was told, was more effective than over-the-counter drugs and had less chance of causing “rebound headaches.” So, I replaced the Excedrin with Sumatriptan.

Chapter 3: Something’s Gotta Give

Sumatriptan worked well for me and allowed me to continue my life with minimal disturbance for a few more years. But the frequency of headaches continued to gradually increase. 10 years into my journey with migraines, I was getting them up to three times a week. Sumatriptan as-needed was no longer a sustainable plan, partly because the U.S. only allows an allotment of 9 Sumatriptan pills per month (more than that is not advised from a safety standpoint), and partly because they didn’t always work when I took them that often.

So, I went back to the neurologist, and this time the recommendation was daily preventative painkillers. My gut said “no.” There had to be a way out of this ever-increasing spiral of head pain and meds. So, I dove into Googling. Fortunately, a mind-body pain reduction app called Curable, which was only 2 years old at the time, popped up in my searches.

I started down the path of mind-body healing (which you can read about here) and soon began to experience a decrease in migraines! I knew I was onto something and I was excited.

Chapter 4: Keeping Score

As I used the Curable app, I tracked my progress closely, writing down every time that I took a Sumatriptan, and watching the number of pills decrease month by month. Seeing my progress in numbers gave me hope and a reason to believe in it. At first.

But then something happened: One month, instead of decreasing, the number of Sumatriptans went up again. And then decreased. And then increased. And leveled out. And increased again. With the help of several mentors, I was introduced to two key lessons of mind-body healing:

1. Recovery is not a straight line. And expecting it to be a smooth ride only puts pressure on the process, which puts stress on your nervous system, which works against recovery.
2. Keeping score — and defining progress by the number of painkillers — also puts pressure on the process, which increases stress, which works against recovery.

Chapter 5: Letting Go

I gave up my Sumatriptan tracking log. Deleting it from my phone felt scary at first, but I could tell that I needed to let go of this perfectionistic score-keeping.

And I set an intention to change my goal: Instead of aiming for fewer painkillers, my aim shifted to increasing self-acceptance and self-care. By “self-care,” I don’t mean pedicures or massages — although those can be part of it. But I mean actually caring about myself. Loving myself. Listening to myself. Spending time learning how to make myself happy — like you would learn how to care for a beloved.

I also made a decision: I was going to stop viewing painkillers as “bad.” I’d picked up this view from some of the mind-body books and lectures I’d come across: The idea that taking painkillers works against mind-body healing; that it’s a way of “giving away your power.”

Some mind-body practitioners believe that it’s important to wean yourself off of pain meds in order to concentrate on mind-body healing. And others don’t. There’s a variety of opinions out there. The opinion I’ve landed on is this: Being kind to myself and helping myself feel better is my path of healing. When I get a flare and it doesn’t subside within a reasonable amount of time, denying myself a painkiller can feel like self-punishment and perfectionism, and that only brings more distress to my nervous system.

As long as I’m not experiencing detrimental side effects from the meds, and as long as I’m heeding safety protocols and contraindications, I will simply take a painkiller and I won’t agonize about it.

Chapter 6: Hiding the Truth — and Self-Trust

The shift of letting go was exactly what I needed. Life got easier and less fraught. My focus and energy began to shift away from tracking painkillers, and I could redirect my energy toward things I actually care about — work, creativity, family and fun!

But there was one lingering piece still gnawing at me: I wasn’t being completely honest with my clients about how often I still take painkillers. Even up until recently, I’ve used the phrase “once in a blue moon.” When the actual truth is, I tend to take a painkiller about once a week.

It’s been a few years since I’ve had a full-blown migraine, but I still have a tendency toward head tension when I’m stressed. And when the tension doesn’t subside reasonably easily through emotional soothing and release techniques, instead of going through my day with head tension, I take a painkiller.

Since I don’t keep a log anymore, I don’t know exactly how many pills I take. I know that there have been particularly stressful weeks when I’ve taken more than one, and particularly relaxed weeks when I haven’t taken any. But the average seems to be once a week these days. That’s less than it was when I started this healing journey, and I imagine that as my nervous system continues to unwind, there will be a time when I’ll take even less and maybe none. However, I don’t hold that as my goal.

When I first began helping others with chronic pain recovery, I thought it was important to model hope and possibility by emphasizing how much I’ve healed. But what I’ve come to realize is this: Hiding the truth about my relationship with painkillers is driven by perfectionism, fear of judgment and shame. None of these are things I want to model for clients. Whereas trusting myself and accepting my truth lets my nervous system feel safer — which continues to further my healing. And that is something I want to share.

I hope that my story inspires you to bring greater acceptance and self-trust to your journey — whatever yours looks like.

Sending love, gentleness and infinite faith in you,

💖 Anna

The post An Honest Account of My Relationship With Painkillers appeared first on Medika Life.

Dallas-based Cedar Health Research is enrolling local patients in two pediatric studies to expand the safe and effective treatment options for children with migraines. Cedar Health Research partners with physicians, like me, in the Dallas/Fort Worth Metroplex and across Texas to expand patient opportunities in clinical trial participation.

Migraine headache is a common childhood problem affecting up to 10% of children age 5-15 and up to 28% of teenagers. When simple measures do not ease the pain, some children require migraine relief medication such as acetaminophen or ibuprofen. Despite these treatments, many children still suffer excruciating pain and require prescription medication. The good news is approximately 25% of children will outgrow migraines by the age of 25. Until then, parents are searching for options to help.

Many drugs approved for adults have not been tested in children resulting in “off-label” use. The Food and Drug Administration initiated a pediatric program to allow well-controlled clinical trials to test the safety and efficacy of adult-approved medication in children.

Parents may find more effective migraine therapy options by enrolling a child in one of these clinical trials.

Headaches in Children

There are two common types of headaches that affect children. A pediatrician or pediatric neurologist will assess a child with recurrent headaches to determine the cause based on a series of diagnostic criteria.

1.Tension headaches. Tension-type headaches cause pain, pressure, or tightness on both sides of the head. The pain can be severe but usually does not interfere with daily activities.

2. Migraine headaches. Migraine headaches often start on one side and get worse over time. Children often have other accompanying symptoms like nausea, light sensitivity, dizziness, or visual changes. Other symptoms include mood changes, fatigue, anxiety, concentration problems, food cravings, neck stiffness, and hyperactivity. The pain can become progressively worse and keep the child from daily activities.

A doctor will help parents and children learn to recognize migraine signs and teach preventative and management steps.

The goal of migraine treatment is to find safe and effective pain relief to help the child return to normal functions as soon as possible. Headache calendars can help identify triggers that lead to migraines. Early interventions, such as taking a nap or resting in a dark room, may help prevent headaches. Lifestyle modifications like stress reduction, improving sleep habits, and dietary changes may help some children.

When these remedies are not effective, doctors will recommend over-the-counter medications such as acetaminophen and nonsteroidal anti-inflammatory drugs like ibuprofen and naproxen. For patients who continue to suffer from migraines, doctors may prescribe FDA-approved medications such as zolmitriptan and sumatriptan.

Rimegepant; A new option for pediatric migraines

Cedar Health Research, located in Dallas and Irving, is currently enrolling candidates in two clinical trials to evaluate the safety and tolerability of Rimegepant in children aged 6-18 with a history of migraines. Rimegepant, from Biohaven Pharmaceuticals, is an FDA-approved medication for adults for the acute treatment of Migraines.

Rimegepant helps adult patients find migraine relief by reducing calcitonin gene-related peptide (CGRP) induced symptoms. The drug’s mechanism of action blocks exaggerated pain signaling, inhibits blood vessel dilation, and reduces inflammation. Although Rimegepant is currently FDA-approved for adults, clinical trials are needed to determine children’s safety and efficacy. 

Phase 1 trial

The phase one clinical trial evaluates the pharmacokinetics of Rimegepant to determine the appropriate weight-based dosing regimen. Participants receive one dose of medication, and then blood samples are performed at four intervals after dosing. This allows scientists to track the body’s absorption of the medicine.

All qualifying candidates will receive the medication and are compensated for their participation.

Candidates must meet eligibility criteria, including:

• Age 6-12 years old
• Weight greater than 15 kg (33 lbs)
• Participants must be able to read and comprehend written instructions
• Participants must have a medically documented 6-month history of migraines
• A qualifying score on the Sheehan Suicidality Tracking Scale (S-STS)
• Must be able to be tolerate blood draws

Phase 3 trial

The phase three trial is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Rimegepant for treating migraines in children age 6-18 years old. This study aims to test how well the study drug works in children compared to a placebo. Up to 1440 participants will undergo evaluation during a 19-week timeline to treat up to two migraines of moderate to severe intensity.

All qualifying candidates will be randomly assigned to receive the medication or placebo and are compensated for their participation. 

Candidates must meet eligibility criteria including:

• Age 12 and 18 years old.
• Participants must experience at least one migraine a month.
• Participants must have a history of migraines for at least 6 months.

Learn more about the FDA Clinical trial process here in this video from theFood and Drug Administration.

Disclosure: The author serves as a principal investigator and sub-investigator in Women’s health studies through Cedar Health Research.

The post Dallas Researchers Recruiting for Pediatric Migraine Clinical Trial appeared first on Medika Life.

Medika selectively features companies recruiting participants for clinical trials. We select these companies and do not receive any remuneration or payment for advertising individual trials or companies.

Study: Migraine – Pain Management

Study Details

Struggling with Migraines?

Migraine headaches are characterized by throbbing in one particular area of the head and can vary from moderate to severe intensity. If you or someone you love suffers from migration headaches, research studies could provide you with treatment options. Those who qualify have access to a licensed physician and compensation for time and travel expenses.

Learn more today!

How to Apply

DFW-East Clinical Site & Corporate Headquarters

Three Forest Plaza
12221 Merit Drive
Suite 350
Dallas, TX 75251 Call: 214-253-8170

Participant Feedback

We encourage study participants to leave feedback on their experience with this trial. You can use the comments section below to rate your experience with Cedar Health Research. This helps others when choosing a trial to participate in.

The post Texas: Migraine Clinical Study Participants – Men and Women appeared first on Medika Life.