Drug free nerve block device for the relief of pain and symptoms in migraines and other headaches
Ended Project Grant Awarded Last action
- Award ID
- R44NS115460
- Recipient
-
Thermaquil, Inc. UEI S8FTDLJNX2K5
- Awarding agency
-
National Institute of Neurological Disorders and Stroke
National Institutes of Health, Department of Health and Human Services
- Obligated
- $4,349,462
Award facts
- Assistance listing
- 93.279 Drug Use and Addiction Research Programs
- Completion date
- Originally
- Funding
-
- $3,351,340.00 Federal
- $998,122.00 Non-federal
- Place of performance
- Pennsylvania, USA
Award details come from USAspending.gov.
Description
- Abstract
- Migraines and headaches are difficult to treat debilitating neurological conditions that leave physicians and their patients with few options for sustained relief from severe chronic pain. All available therapies have considerable side-effects or limitations, leading many patients to resort to drug cocktails including narcotics. To reduce or eliminate the need to use opiates and systemic pharmaceuticals to treat headaches and migraine, thermaquil developed the first noninvasive, drug-free, patient-controlled reversible nerve block device for long term pain management based on novel mechanisms-of-action that we discovered. Thermaquil has met with more than 300 physicians and headache patients who have vetted and guided the development of thermaquil's noninvasive nerve block device. The system is designed to easily be used during normal daily activities. We've demonstrated clear efficacy of thermal neuromodulation in single-arm studies with highly complex patients who have tried and failed all other available treatments. Our 45 participants' baseline pain of 6.1 ± 1.7 was significantly reduced to 2.6 ± 2.5 ( P < 0.05, P = 6E-12). Most participants have had constant headache every day over the past 28 days, which would exclude them from most other headache and migraine clinical trials. The proposed study begins with a 28-day lead-in phase to establish a baseline for participant headache frequency, intensity, medications used, other healthcare utilization, and quality of life. After the baseline period, all participants are randomized into active or control arms and given a single treatment. The study continues for 12 weeks with active versus control therapy arms before all participants are given active therapy for an additional 12 weeks. This sham-controlled study will provide evidence of the safety and effectiveness of the thermaquil device relieving migraine and headache attacks. Successful completion of the project will 1) justify the company to pursue a larger efficacy/pivotal trial to move towards regulatory approval and 2) result in additional investment opportunities for thermaquil to expedite our clinical program to rapidly bring this product to market to help stop migraine and other pain for individuals with chronic migraine or other headaches.
Transactions
| Action | Federal | Non-federal | Date |
|---|---|---|---|
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $677,548 | $0 | |
| Amendment | $677,548 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $998,122 | $0 | |
| Original award | $998,122 | $998,122 |
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Quick answers
Who received award R44NS115460?
R44NS115460 was awarded to Thermaquil, Inc. by National Institute of Neurological Disorders and Stroke (National Institutes of Health) on April 29, 2020.
How much is award R44NS115460 worth?
$4,349,462 has been obligated on R44NS115460: $3,351,340 in federal funding and $998,122 in non-federal funding.
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