# Real-world Evidence Study with Patient Input to evaluate Treatment Effects in Trigeminal Neuralgia (RESPITE-TN)

> **NIH NIH K01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2024 · $154,958

## Abstract

PROJECT SUMMARY
The objective of this NIDCR Mentored Career Development Award to Promote Diversity (K01) is to provide Dr.
Juan Hincapie-Castillo with the essential training to become an independent researcher in real-world evidence
for precision pain management applied to trigeminal neuralgia (TN). TN is associated with severe and
debilitating orofacial pain that can result in a significant decline in the quality of life for older adults. The aging
population experiencing TN is at high risk for central nervous system depression with psychotropic
medications, including antiepileptic drugs. Gabapentin, an antiepileptic commonly used to treat neuropathic
pain, is often prescribed as the initial medication for TN despite clinical recommendations of using
carbamazepine or oxcarbazepine as first line treatments – to date no evidence exists, outside limited case
reports, on the patient-reported lived experience nor comparative safety of these drugs in the real world.
Although real-world data sources, such as Medicare administrative claims, offer an opportunity to evaluate
drug-related health outcomes, valid causal inference requires contextual clinical knowledge and competency in
advanced analytical methods. The training goals in this K01 include: (1) Expanding clinical expertise in the
substantive area of orofacial pain and TN; (2) Building skills in primary data collection and engagement of
people with lived experience of pain in research; and (3) Learning and applying robust advanced causal
inference methods and machine learning algorithms for assessment of treatment effect heterogeneity. This
career development award will be carried out at the University of North Carolina at Chapel Hill and will be
guided by a mentoring team comprising leading experts in biomedical research. Leveraging this mentored
training, Dr. Hincapie-Castillo will apply new expertise in TN and analytical skills into the following research
aims: (1) Document patient-reported experiences of initial diagnosis and treatment of TN through the collection
and synthesis of primary qualitative and quantitative data; (2) Develop and validate a Medicare claims-based
algorithm for incident diagnoses of TN by appraising reference diagnostic data from medical charts from a
large academic hospital; and (3) Investigate the risk of injurious falls caused by antiepileptics among Medicare-
insured patients diagnosed with TN using advanced causal inference pharmacoepidemiologic methods and
causal forests to identify variation in treatment effects. Study findings will generate critical real-world evidence
to guide patient-centered care in TN by contextualizing and assessing drug safety concerns relevant to older
adults. Extending beyond comparative safety evaluations in this patient population, this K01 award will lay the
foundation for future R01-level research focused on identifying effective pharmacological and non-
pharmacological TN treatments using novel machine learning methods in real-worl...

## Key facts

- **NIH application ID:** 10866018
- **Project number:** 1K01DE033698-01
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Juan Manuel Hincapie Castillo
- **Activity code:** K01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $154,958
- **Award type:** 1
- **Project period:** 2024-02-05 → 2025-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10866018

## Citation

> US National Institutes of Health, RePORTER application 10866018, Real-world Evidence Study with Patient Input to evaluate Treatment Effects in Trigeminal Neuralgia (RESPITE-TN) (1K01DE033698-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10866018. Licensed CC0.

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