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Gabapentin for Loss of Smell Post-COVID-19 (GRACE Trial)

Phase 2

Waitlist Available

Led By Jay F Piccirillo, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women between the ages of 18 and 65 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after completion of eight-week fixed-dose period, and 4 weeks after completion of taper-down period

Awards & highlights

GRACE Trial Summary

This trial will study if an oral drug can help improve smell after Covid-19. It's a randomized, double-blinded, placebo-controlled study.

Who is the study for?

This trial is for adults aged 18-65 in Missouri or Illinois who've lost their sense of smell for at least 3 months after COVID-19. They must have certain household items and a low score on a smell test (UPSIT). People can't join if they use specific drugs, have addictions, severe allergies to peanuts, are pregnant, or lack internet/texting access.Check my eligibility

What is being tested?

The study tests whether Gabapentin helps improve the sense of smell in people affected by COVID-19. Participants will either receive Gabapentin capsules or a placebo without knowing which one they're taking. The process is random and both researchers and participants won't know who's receiving the actual medication.See study design

What are the potential side effects?

Gabapentin may cause side effects like dizziness, sleepiness, water retention leading to swelling in limbs, difficulty walking, changes in sensation such as numbness or tingling.

GRACE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

GRACE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after completion of eight-week fixed-dose period, and 4 weeks after completion of taper-down period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after completion of eight-week fixed-dose period, and 4 weeks after completion of taper-down period

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after completion of eight-week fixed-dose period, and 4 weeks after completion of taper-down period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Clinical Global Impression - Severity Scale for Parosmics (CGI-P)

Clinical Global Impression of Improvement Scale (CGI-I)

Clinical Global Impression of Severity Scale (CGI-S)

+3 more

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815

Allergic reaction

100%

80%

60%

40%

20%

Study treatment Arm

Gabapentin

Benzodiazepine

GRACE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GabapentinExperimental Treatment1 Intervention

This arm will be given the active treatment, oral Letco (gabapentin) gelatin capsules of 300mg each. Up to the first four weeks will be a titration period (week 1 300mg TID, week 2 600mg TID, week 3 900mg TID, week 4 1,200mg TID) as tolerated. If intolerable adverse reactions occur, the dosage will be decreased to prior tolerable dose (e.g., if 900mg TID is intolerable, dose will be decreased to 600mg TID). The following eight weeks will be fixed dose, the highest tolerable dose from the titration period. Up to two weeks will be a taper down tailored to the maximum dose the participant reached during the titration and fixed periods. A maximum 14 weeks will mark the end of active treatment. Follow-up assessments will be conducted 4 weeks after completion of the taper-down period.

Group II: PlaceboPlacebo Group1 Intervention

Placebo gelatin capsules that look, smell, and taste like gabapentin capsules will be given to the placebo arm. To preserve double-blinding of the study, subjects will receive one capsule TID the first week, the second week two capsules TID, the third week three capsules TID, and fourth week four capsules TID as tolerated. If intolerable, the dose will be decreased to prior tolerable dose. The next eight weeks will be a fixed amount of placebo based on the highest tolerable amount from the titration period. Subjects will then taper-down placebo to imitate the gabapentin arm for maximum two weeks based on highest dose achieved during study. 4 weeks after completion of taper-down, follow-up assessments will be conducted.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gabapentin gelatin capsules 300mg

2022

Completed Phase 2

~80

0 / 1Eligibility criteria met