Trial results for a study evaluating two digital therapeutics for the prevention of episodic migraine were posted on ClinicalTrials.gov on 2025-07-03. The digital therapeutic CT-132 demonstrated a least squares mean reduction of -3.04 monthly migraine days, compared to -2.14 for the digital control arm.
Background
Migraine is a debilitating neurological condition characterized by severe headaches, often accompanied by symptoms such as throbbing pain, sensitivity to light and sound, and nausea. Episodic migraine, defined by fewer than 15 headache days per month, significantly impacts quality of life for millions worldwide. Current preventive treatments include various pharmacological options, but many patients seek non-pharmacological alternatives due to side effects or insufficient efficacy. Digital therapeutics offer a novel approach to migraine prevention, providing accessible, software-based interventions that can be delivered directly to patients.
Trial design
This completed study, which did not specify a phase, enrolled 568 participants diagnosed with Migraine, Episodic Migraine, or Headache. The trial was a randomized study designed to compare the efficacy of two digital therapeutics for the prevention of episodic migraine. Participants were assigned to either Arm A, receiving the digital therapeutic CT-132, or Arm B, receiving a digital control.
Key results
The trial results highlighted several key measurements regarding the reduction in monthly migraine days (MMD) and the proportion of responders:
- For the outcome "Change in MMD (Monthly Migraine Days)", the least squares mean change for Arm A (CT-132) was -3.04 migraine days per month. For Arm B (Digital Control), the least squares mean change was -2.14 migraine days per month.
- Regarding "Participants Who Have at Least a 50% Reduction From Baseline", 141 participants in Arm A (CT-132) met this criterion, compared to 113 participants in Arm B (Digital Control). Another measurement for this outcome reported 125 participants in Arm A (CT-132) and 151 participants in Arm B (Digital Control).
- For "Change From Baseline in the Number of MMD Recorded Over the Previous 28 Days at Week 4 and Week 8":
- At Week 4, the mean change for Arm A (CT-132) was -1.58 migraine days per month (Standard Deviation: 3.55), while for Arm B (Digital Control), it was -1.20 migraine days per month (Standard Deviation: 3.31).
- At Week 8, the mean change for Arm A (CT-132) was -2.24 migraine days per month (Standard Deviation: 3.92), and for Arm B (Digital Control), it was -1.87 migraine days per month (Standard Deviation: 3.65).
- For "Change From Baseline in the Mean Number of MMD Over 12 Weeks", the mean change for Arm A (CT-132) was -3.35 migraine days per month (Standard Deviation: 3.63), compared to -2.26 migraine days per month (Standard Deviation: 3.67) for Arm B (Digital Control).
What this means
The posted trial results suggest that the digital therapeutic CT-132 demonstrated a numerically greater reduction in monthly migraine days compared to a digital control in patients with episodic migraine. Specifically, the least squares mean reduction of -3.04 MMD for CT-132 indicates a clinically meaningful improvement for patients. While the digital control also showed a reduction, CT-132 consistently outperformed it across several measurements, including the overall change in MMD over 12 weeks. These findings suggest that CT-132 could offer a valuable non-pharmacological option for the prevention of episodic migraine, potentially improving patient outcomes and providing an accessible alternative for those seeking new preventive strategies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05853900, titled "Study of Two Digital Therapeutics for the Prevention of Episodic Migraine", were posted on 2025-07-03 on clinicaltrials.gov.