Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction (NCT05184192) | Clinical Trial Compass
CompletedPhase 2
Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction
United States68 participantsStarted 2022-01-10
Plain-language 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 trial.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Clinical Global Impression of Improvement Scale (CGI-I)
Timeframe: After the 8 week FD phase and four week post-tapper