Trial · NCT05900466
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the safety and efficacy of low-dose metformin in improving the symptoms associated with FMS | 12-14 weeks | Safety will be measured by the Fibromyalgia Impact Questionnaire, Revised (FIQ-R score and will measure overall FMS severity. The numeric scale ranges from 0-10 with 0 being "low difficulty" (better outcome) and 10 being "high difficulty" (worse outcome). |
| Secondary | Examine changes in individual FMS symptoms - Pain Intensity | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of pain intensity (PROMIS Pain Intensity SF3a). The scale ranges from 0-10, 0 being "no pain" (better outcome) and 10 being "worst pain imaginable" (worse outcome). |
| Secondary | Examine changes in individual FMS symptoms - Fatigue | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of fatigue (PROMIS Fatigue SF7a). The scale ranges from 1-5, 1 being "not at all" (better outcome) and 5 being "very much" (worse outcome). |
| Secondary | Examine changes in individual FMS symptoms - Sleep Disturbance | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of sleep disturbance (PROMIS Sleep Disturbance SF8b). The scale ranges from 1-5, 1 being "very poor" or "not at all" (worse outcome) and 5 being "very good" or "very much" (better outcome). |
| Secondary | Examine changes in individual FMS symptoms - Depression | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of depression (PROMIS Depression SF8b). The scale ranges from 1-5, 1 being "never" (better outcome) and 5 being "always" (worse outcome). |
| Secondary | Examine changes in individual FMS symptoms - Anxiety | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of anxiety (PROMIS Anxiety SF7a). The scale ranges from 1-5, 1 being "never" (better outcome) and 5 being "always" (worse outcome). |
| Secondary | Examine changes in individual FMS symptoms - Physical Function | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of physical functioning (PROMIS Physical Function SF10a). The scale ranges from 1-5, 1 being "unable to do" (worse outcome) and 5 being "without any difficulty" (better outcome). |
| Secondary | Examine changes in individual FMS symptoms - Perceived Cognitive Function | 12-14 weeks | Efficacy will be evaluated for a range of symptoms through the PROMIS Short Form measures of perceived cognitive functioning (title: Multiple Ability Self-Report Questionnaire (MASQ)). The scale ranges from 1-5 with 1 being "never" (better outcome) to 5 being "always" (worse outcome). |
| Secondary | Examine changes in ecological momentary assessment (EMA) symptoms | 12-14 weeks | EMA will allow us to evaluate symptom variations at home environment |
| Secondary | Examine patient's global improvement impression | 12-14 weeks | Global impression of improvement scale will be used to assess clinical global impression (CGI). Global impression of improvement scale is a 7-point scale. Scores range from 1 being the better outcome (i.e. "normal", "improved") and 7 being the worse outcome (i.e. "most severely ill", "very much worse"). |
| Secondary | Examine adherence | Week 4 and week 14 | Pill counts will provide us with a measure of adherence |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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