Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Clinical Global Impression of Improvement Scale (CGI-I)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double-blinded, both participants and investigators will be blinded. Intervention will be packaged in blinded fashion by pharmacist before being shipped to participants by research assistant
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Gabapentin
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.
干预措施: Gabapentin gelatin capsules 300mg (Drug)
Placebo
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Global Impression of Improvement Scale (CGI-I)
时间窗: After the 8 week FD phase and four week post-tapper
The primary outcome measure was the treatment response rate following the 8-week FD phase as determined by the CGI-I. The CGI-I is a modified 7-point Likert scale of -perceived change. Response options include: (1) much better, (2) somewhat better, (3) slightly better), (4) neither better nor worse, (5) slightly worse, (6) somewhat worse, (7) much worse. The response rate was defined as the number of participants self-reporting at least "slightly better" divided by the number of participants in each treatment group. Th
次要结局
- University of Pennsylvania Smell Identification Test (UPSIT)(Baseline, after completion of eight-week fixed-dose period, and 4 weeks after completion of taper-down period)
- Olfactory Dysfunction Outcomes Rating (ODOR)(Baseline, after completion of eight-week fixed-dose period, and 4 weeks after completion of taper-down period)
- NASAL-7(Baseline, after completion of eight-week fixed-dose period, and 4 weeks after completion of taper-down period)
- CGI-Severity of Smell(8-week Fixed-Dose period, and 4 weeks after completion of Taper-Down phase)
- CGI-S of Parosmia(8-week Fixed-Dose period, and 4 weeks after completion of Taper-Down phase)