Gabapentin Treatment of Postural Tachycardia Syndrome (PoTS)

April 10, 2020 updated by: Ramesh Khurana, Medstar Health Research Institute

Gabapentin Treatment of Postural Tachycardia Syndrome (PoTS): a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postural orthostatic tachycardia syndrome (POTS) is a disorder of the autonomic nervous system. The autonomic nervous system regulates major bodily functions, such as blood pressure, heart rate, body temperature and sweating. Patients with POTS experience heart palpitations, lightheadedness, and increased heart rate upon standing as well as other symptoms, such as nausea, foggy headedness or inability to concentrate, sensitivity to light, migraine headaches, and trouble sleeping that may occur even when these patients are not standing. Because many POTS symptoms are attributed to excessive activity in parts of the brain, the investigator would like to study whether some of these symptoms can be reduced with a proven seizure medication, gabapentin.

The investigator will perform several simple tests on a group of POTS patients both before and after they have been treated with this drug. The tests will include non-invasive heart rate and blood pressure monitoring during a maneuver that requires the participant to exhale in a continuous manner as if blowing up a balloon, an assessment of sensitivity to light, and completion of several questionnaires that assess sleep behavior and sensitivity to heart, bowels, and bladder. Participants will take gabapentin for one week and placebo for another week. Neither the investigator nor the participant will know beforehand whether the participant is taking gabapentin or placebo. The investigator will then compare the results of pre-trial tests to post-trial tests to determine how effective gabapentin was at alleviating symptoms. If the trial is effective, the investigator expects gabapentin to reduce palpitations, decrease sensitivity to light, and improve sleep behavior.

Risks of this study may include participants developing side-effects due to the drug. Side-effects of gabapentin may include dizziness, drowsiness, diarrhea, dry mouth, constipation, vomiting, loss of balance, allergic reaction, fatigue, and indigestion. If any side-effects occur, the investigator anticipates that they will be mild because the drug will be administered at a very low dose. Any side-effects that occur are expected to resolve quickly after stopping the medication. Furthermore, by gradually increasing the dose and restricting the trial to a relatively short period of time, the investigator will limit the risk of side-effects.

Doctors and patients alike could benefit from this study by learning about a new use for an established drug to treat several of the symptoms of POTS, thereby improving patients' quality of life.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults between the ages of 18 and 60 years of age
  • For women of childbearing age, no missed menstrual cycles
  • Diagnosis of POTS confirmed by the PI after autonomic function tests
  • Able to discontinue GABAergic drugs, beta blockers, and sleep medication for one week before study start-up and for the duration of the study
  • Able to read and understand English

Exclusion Criteria:

  • Men and women under 18 and over 60 years of age

    • Unable to read or understand English
    • A history of gastroparesis, renal or hepatic dysfunction, cardiac arrhythmias, eye disorders and sleep apnea

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gabapentin

The experiment will be divided into the following phases:

  • Baseline phase - Demographic and test data will be collected prior to dispensing trial medication using all measures listed above
  • 7 day trial phase with gradual increase of dose from 100 mg/day to 600 mg/day (300 b.i.d) on day 6 of gabapentin or placebo. A single morning dose (300 mg) will be given at the lab on day 7 followed by post-trial testing (using above measures) 1 hour after drug administration.
  • 7 day drug washout phase - no medication will be taken
  • 7 day crossover trial phase - baseline measurements will be repeated and groups will switch to gabapentin or placebo. Post-trial measurements will be taken 1 hour after a single morning dose (300 mg) on day 7.
  • Follow-up phone call - Patients will be called 8-10 days after completion of study to ensure that there have been no unexpected events.
Drug: Gabapentin
Gradually increasing doses of "medication" from 100 mg on day 1 to 300 mg twice a day on day 6. On day 7, the patient received a 300-mg dose from the day 7 envelope, about two hours after a light breakfast and 1 hour before data collection. The relatively low dose and gradual titration were selected to enhance compliance and reduce adverse effects, based on a rectal mechanosensitivity study.
Placebo Comparator: Placebo

The experiment will be divided into the following phases:

  • Baseline phase - Demographic and test data will be collected prior to dispensing trial medication using all measures listed above
  • 7 day trial phase with gradual increase of dose from 100 mg/day to 600 mg/day (300 b.i.d) on day 6 of gabapentin or placebo. A single morning dose (300 mg) will be given at the lab on day 7 followed by post-trial testing (using above measures) 1 hour after drug administration.
  • 7 day drug washout phase - no medication will be taken
  • 7 day crossover trial phase - baseline measurements will be repeated and groups will switch to gabapentin or placebo. Post-trial measurements will be taken 1 hour after a single morning dose (300 mg) on day 7.
  • Follow-up phone call - Patients will be called 8-10 days after completion of study to ensure that there have been no unexpected events.
Drug: Gabapentin
Gradually increasing doses of "medication" from 100 mg on day 1 to 300 mg twice a day on day 6. On day 7, the patient received a 300-mg dose from the day 7 envelope, about two hours after a light breakfast and 1 hour before data collection. The relatively low dose and gradual titration were selected to enhance compliance and reduce adverse effects, based on a rectal mechanosensitivity study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Acute Panic Inventory (API)
Time Frame: at baseline, at 1 week from baseline (upon completion of first treatment), at 2 weeks from baseline (upon completion of washout period), at 3 weeks from baseline (upon completion of second treatment)
Acute Panic Inventory is a validated 17-item (4 psychological and 13 somatic/visceral) questionnaire. Patients rate each item on a 4-point severity scale of 0 to 3, yielding a score of 0-51. An increase in API score >13 over baseline or a total score of >20 distinguished panic subjects from controls.
at baseline, at 1 week from baseline (upon completion of first treatment), at 2 weeks from baseline (upon completion of washout period), at 3 weeks from baseline (upon completion of second treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Palpitation Awareness and Severity Response
Time Frame: at baseline, at 1 week from baseline (upon completion of first treatment), at 2 weeks from baseline (upon completion of washout period), at 3 weeks from baseline (upon completion of second treatment)
In the Palpitation Awareness and Severity Response, the patient identifies one or more of the eight types of palpitations and grades their severity (1-10) immediately after the Valsalva maneuver (expiratory strain of 40 mm Hg for 15 seconds).
at baseline, at 1 week from baseline (upon completion of first treatment), at 2 weeks from baseline (upon completion of washout period), at 3 weeks from baseline (upon completion of second treatment)
Change in Insomnia Severity Index
Time Frame: at baseline, at 1 week from baseline (upon completion of first treatment), at 2 weeks from baseline (upon completion of washout period), at 3 weeks from baseline (upon completion of second treatment)
Insomnia Severity Index is a validated 7-item questionnaire rating severity of insomnia on a 5-point (zero to 4) scale yielding a score of 0-28, with a score of >14 indicating insomnia.
at baseline, at 1 week from baseline (upon completion of first treatment), at 2 weeks from baseline (upon completion of washout period), at 3 weeks from baseline (upon completion of second treatment)
Change in Photosensitivity Index
Time Frame: at baseline, at 1 week from baseline (upon completion of first treatment), at 2 weeks from baseline (upon completion of washout period), at 3 weeks from baseline (upon completion of second treatment)
The Photosensitivity Index is a 10-point visual analog of scale yielding a score of 0-10 to rate glare and pain after 30-second exposure of ophthalmoscopic light in each eye in a dimly lit room. Higher score indicates greater sensitivity to light.
at baseline, at 1 week from baseline (upon completion of first treatment), at 2 weeks from baseline (upon completion of washout period), at 3 weeks from baseline (upon completion of second treatment)
Change in Somatosensory Amplification Scale (SSAS)
Time Frame: at baseline, at 1 week from baseline (upon completion of first treatment), at 2 weeks from baseline (upon completion of washout period), at 3 weeks from baseline (upon completion of second treatment)
The Somatosensory Amplification Scale is a validated 5-point severity scale used to investigate the possibility of perceptual amplification of symptoms. The scale covers 10 somatic and visceral sensations to quantify symptom amplification yielding a score of 0-50, with higher score indicating greater somatosensory amplification. A score >30 may reflect a highly somatizing condition.
at baseline, at 1 week from baseline (upon completion of first treatment), at 2 weeks from baseline (upon completion of washout period), at 3 weeks from baseline (upon completion of second treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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