NCT05005351已完成2 期
"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 14
- 主要终点
- Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score
研究概览
简要总结
This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks. The primary endpoint is mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score.
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
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 22 to 75 years of age, inclusive
- •Subject has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM, which requires satisfaction of the following criteria:
- •Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5, OR WPI 4-6 and SS scale score ≥9;
- •Symptoms have been present at a similar level for at least 3 months;
- •Pain must be present in at least 4 out of 5 body regions
- •Subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.
- •Subject is capable of reading and understanding English and has provided written informed consent to participate.
排除标准
- •Lifetime history of bipolar disorder as assessed by the MINI.
- •Current, untreated, major depressive episode and/or anxiety disorders as assessed by the MINI.
- •Subject has a BDI-II total score > 25 at either the Screening appointment or Baseline appointment.
- •The subject is at increased risk of suicide on the basis of the investigator's judgment, a response > 1 to BDI item #9, or the results of the Columbia-Suicide Severity Rating Scale ("C-SSRS") conducted at Screening or Baseline (i.e., any suicidal behavior during the preceding year or C-SSRS Type 3, 4, or 5 suicidal ideation during the preceding year).
- •Subject has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the subject, interfere with the evaluation of the study device's efficacy or safety, or compromise the subject's ability to comply with/complete the study.
结局指标
主要结局
Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score
时间窗: Baseline to Week 12
FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.
次要结局
- Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement(Week 12)
研究者
研究点 (14)
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