Status:
COMPLETED
Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction
Lead Sponsor:
Washington University School of Medicine
Conditions:
COVID-19
Olfactory Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will investigate the efficacy of oral gabapentin in olfactory improvement following Covid-19- associated olfactory dysfunction. This is a randomized, double-blinded, placebo-controlled tria...
Detailed Description
The drug will be given over a maximum 14 weeks with up to four weeks titrating up, eight weeks maintaining highest tolerable dose, and up to two weeks tapering down. Change in olfactory function from ...
Eligibility Criteria
Inclusion
- Men and women between the ages of 18 and 65 years
- Residing within the states of Missouri or Illinois
- Clinically diagnosed or subjective olfactory dysfunction (anosmia, hyposmia, or parosmia) of 3 months duration or longer diagnosed within 2 weeks of Covid-19 infection
- UPSIT score consistent with diminished olfactory function (score ≤ 33 in men and ≤ 34 in women).
- Willing to respond daily to study surveys, preferably through smartphone with unlimited texting plan
- In possession of ALL 7 household items: soap, burnt candle, peanut butter, herb, garlic, lemon, and coffee
Exclusion
- Clinically diagnosed olfactory dysfunction secondary to genetic abnormalities or congenital dysfunction, trauma, non-Covid-19 viral infection, nasal polyps, neurodegenerative disorders
- Current use of: azelastine, bromperidol, orophenadrine, oxomemazine, kratom, paraldehyde, or thalidomide
- History of addiction to alcohol, cocaine, or opioids
- Impaired renal function, myasthenia gravis, or myoclonus
- Severe allergy to peanuts
- Pregnancy or attempting pregnancy during study participation
- Inability to participate in virtual trial due to lack of access to the internet or unlimited text messaging; inability to comprehend or use English language
- Availability less than 6 months from time of enrollment
- Residency in states other than Missouri or Illinois.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2023
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05184192
Start Date
January 10 2022
End Date
August 29 2023
Last Update
March 4 2025
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110