drugset / Trial / NCT04345432
Gabapentin Treatment of Postural Tachycardia Syndrome (PoTS)
RandomizedCrossoverDouble-blindTreatment
Summary
In this pilot study, the investigator will test the usefulness of gabapentin in treating some of the symptoms associated with POTS. Gabapentin is FDA-approved to treat epilepsy and nerve pain and works by reducing excessive activity in the nervous system. This medication has also been shown to be effective in reducing bowel discomfort in patients with irritable bowel syndrome, sleeplessness, and possibly migraine headache. The investigator has observed positive results when prescribing gabapentin off-label to alleviate photosensitivity and headaches in POTS patients. The aim of this pilot study is to better quantify what the investigator has seen and evaluate whether it merits further study in a larger group.
Timeline
- Start
- 2014-01
- Primary completion
- 2017-09
- Completion
- 2017-09
Publications
- Background Benarroch EE. Postural tachycardia syndrome: a heterogeneous and multifactorial disorder. Mayo Clin Proc. 2012 Dec;87(12):1214-25. doi: 10.1016/j.mayocp.2012.08.013. Epub 2012 Nov 1.
- Background Cortez MM, Digre K, Uddin D, Hung M, Blitzer A, Bounsanga J, Voss MW, Katz BJ. Validation of a photophobia symptom impact scale. Cephalalgia. 2019 Oct;39(11):1445-1454. doi: 10.1177/0333102419845641. Epub 2019 May 22.
- Background Dooley DJ, Taylor CP, Donevan S, Feltner D. Ca2+ channel alpha2delta ligands: novel modulators of neurotransmission. Trends Pharmacol Sci. 2007 Feb;28(2):75-82. doi: 10.1016/j.tips.2006.12.006. Epub 2007 Jan 10.
- Background Drummond PD. A quantitative assessment of photophobia in migraine and tension headache. Headache. 1986 Oct;26(9):465-9. doi: 10.1111/j.1526-4610.1986.hed2609465.x. No abstract available.
- Background Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, Cheshire WP, Chelimsky T, Cortelli P, Gibbons CH, Goldstein DS, Hainsworth R, Hilz MJ, Jacob G, Kaufmann H, Jordan J, Lipsitz LA, Levine BD, Low PA, Mathias C, Raj SR, Robertson D, Sandroni P, Schatz I, Schondorff R, Stewart JM, van Dijk JG. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res. 2011 Apr;21(2):69-72. doi: 10.1007/s10286-011-0119-5. No abstract available.
- Background Gagnon C, Belanger L, Ivers H, Morin CM. Validation of the Insomnia Severity Index in primary care. J Am Board Fam Med. 2013 Nov-Dec;26(6):701-10. doi: 10.3122/jabfm.2013.06.130064.
- Background Khurana RK. Orthostatic intolerance and orthostatic tachycardia: a heterogeneous disorder. Clin Auton Res. 1995 Feb;5(1):12-8. doi: 10.1007/BF01845493.
- Background Khurana RK. Experimental induction of panic-like symptoms in patients with postural tachycardia syndrome. Clin Auton Res. 2006 Dec;16(6):371-7. doi: 10.1007/s10286-006-0365-0. Epub 2006 Aug 16.
- Background Lee KJ, Kim JH, Cho SW. Gabapentin reduces rectal mechanosensitivity and increases rectal compliance in patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2005 Nov 15;22(10):981-8. doi: 10.1111/j.1365-2036.2005.02685.x.
- Background Lo HS, Yang CM, Lo HG, Lee CY, Ting H, Tzang BS. Treatment effects of gabapentin for primary insomnia. Clin Neuropharmacol. 2010 Mar-Apr;33(2):84-90. doi: 10.1097/WNF.0b013e3181cda242.
- Background Nwazue VC, Arnold AC, Raj V, Black BK, Biaggioni I, Paranjape SY, Orozco C, Dupont WD, Robertson D, Raj SR. Understanding the placebo effect in clinical trials for postural tachycardia syndrome. Clin Exp Pharmacol Physiol. 2014 May;41(5):325-30. doi: 10.1111/1440-1681.12221.
- Background Ross AJ, Ocon AJ, Medow MS, Stewart JM. A double-blind placebo-controlled cross-over study of the vascular effects of midodrine in neuropathic compared with hyperadrenergic postural tachycardia syndrome. Clin Sci (Lond). 2014 Feb;126(4):289-96. doi: 10.1042/CS20130222.
- Background Wells R, Elliott AD, Mahajan R, Page A, Iodice V, Sanders P, Lau DH. Efficacy of Therapies for Postural Tachycardia Syndrome: A Systematic Review and Meta-analysis. Mayo Clin Proc. 2018 Aug;93(8):1043-1053. doi: 10.1016/j.mayocp.2018.01.025. Epub 2018 Jun 21.
- Background Zeng Y, Hu D, Yang W, Hayashinaka E, Wada Y, Watanabe Y, Zeng Q, Cui Y. A voxel-based analysis of neurobiological mechanisms in placebo analgesia in rats. Neuroimage. 2018 Sep;178:602-612. doi: 10.1016/j.neuroimage.2018.06.009. Epub 2018 Jun 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Small molecule | 300 mg | — |