NCT05184192

Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 baseline to completion of 8-week fixed-dose period will be compared between the two study groups. Follow-up assessments will be conducted for both groups 4 weeks after completion of taper down.

Conditions

• COVID-19
• Olfactory Disorder
• Anosmia
• Hyposmia
• Parosmia

Interventions

Type	Name	Description
DRUG	Gabapentin gelatin capsules 300mg	Gabapentin is an anti-epileptic also used for nerve pain. This study will investigate the efficacy of gabapentin for olfactory nerve recovery and improvement in post-Covid-19 olfactory dysfunction.
DRUG	Placebo	lactose monohydrate NF

Timeline

• Start date: 2022-01-10
• Primary completion: 2023-08-29
• Completion: 2023-08-29
• First posted: 2022-01-11
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study