2024-516174-30-01已完成2 期
Investigation of pregabalin therapy and complex rehabilitation in treating chronic fatigue associated with post-COVID syndrome
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2023年3月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score at 3 and 6 months of the study relative to the baseline score.
研究概览
简要总结
Assessment of efficacy for pregabalin and complex rehabilitation in treating chronic fatigue syndrome associated with post-COVID syndrome
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The patient correctly gave written informed consent to participate in the study;
- •Men or women between the ages of 18 and 65 inclusive at the time of signing the informed consent;
- •Patient after a minimum of 6 months from the documented detection of SARS-CoV-2 infection (document confirming the history of the disease, including a positive result of the PCR or antigen test, certificate of convalescence; medical documentation confirming the infection; the condition is also considered fulfilled in the case of documented infection asymptomatic);
- •During the screening, the patient meets the criteria for the diagnosis of chronic fatigue syndrome (CFS) according to National Academy of Medicine (2015);
- •Women: a) incapable of having children (post-menopausal or child-bearing, subjected to permanent sterilization); (b) of childbearing potential with a negative pregnancy test result at screening and using a highly effective method of contraception throughout the IMP use and for 7 days after the last IMP use.
- •The patient agrees to participate in all activities provided for in the study.
- •The patient is able to understand the information presented and give informed consent to participate in the study prior to screening.
排除标准
- •Vital functions disorders;
- •Documented hypersensitivity to pregabalin or any of the excipients of the formulation (i.e., lactose);
- •Moderate or severe depression during treatment or present during psychiatric evaluation at baseline;
- •Concurrent treatment with opioids or other antiepileptic drugs (including tramadol, buprenorphine, morphine, oxycodone, gabapentin, duloxetine);
- •Pregnant or breastfeeding women;
研究组 & 干预措施
Preato-Placebo
Placebo
干预措施: Preato-Placebo (Drug)
Preato,75 mg, tabletki
Test
干预措施: Preato,75 mg, tabletki (Drug)
结局指标
主要结局
Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score at 3 and 6 months of the study relative to the baseline score.
Change in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score at 3 and 6 months of the study relative to the baseline score.
Walking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline.
Walking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline.
次要结局
- Change in the degree of satisfaction with life expressed as the result of the Life Satisfaction Scale (Juczyński) in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in the result obtained in the "Beck Depression Inventory (BDIII)" in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI) in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in the degree of acceptance of the disease assessed by the Illness Acceptance Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day the study began.
- Change in the CTT-1 and CTT-2 test result in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in the result of the Wisconsin Card Sorting Test (WCST) in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in the RFFT test result in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in the result in the WAIS-R Digit Repetition subtest in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in reaction time in the Stroop interference test in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in the gait quality assessment in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in walking speed in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in reaction time expressed in the Peg Insertion Test in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in the d2-R test result in the 3rd and 6th month of the study compared to the result on the day the study began.
- Change in the score on the Athens Insomnia Scale in the 3rd and 6th month of the study compared to the score on the day the study began.
- Change in the Mini-Cope result in the 3rd and 6th month of the study compared to the result on the day the study began.
- The exploratory endpoint is the change in the profile of tested inflammatory cytokines in the 6th month of the study compared to the result before the start of the study. We allow for the possibility of additional exploratory endpoints during the study, before unblinding.
- Security related endpoints: • Number of adverse events and the number and percentage of patients who experienced adverse events. • Number of adverse events and the number and proportion of patients who experienced treatment-related adverse events. • Number of serious adverse events and number and proportion of patients with serious adverse events. • Number of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.
- Number and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.
研究者
Centrum Wsparcia Badań Klinicznych
Scientific
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
研究点 (1)
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