Trial · NCT07196657
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of patients achieving pain relief | At the 12-weeks | The proportion of patients achieving pain relief defined as the proportion of patients whose baseline average pain intensity is reduced by at least 50%. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable. |
| Secondary | The average pain intensity | At the weeks 1, 2, 4, 8, and 12 | The average pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable. |
| Secondary | The worst pain intensity | At the weeks 1, 2, 4, 8, and 12 | The worst pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable. |
| Secondary | Dose of crisugabalin or pregabalin | At the week 1, 2, 4, 8, 12 | the dose of experimental drug |
| Secondary | Average weekly consumption of rescue analgesics | at weeks 4, 8, 12 | Acetaminophen will be permitted as rescue medication for FM-related pain, at doses up to 1000 mg per administration and not exceeding 3000 mg per day. All rescue medication use, including dose and frequency, will be recorded prospectively. |
| Secondary | The Revised FM Impact Questionnaire | At the weeks 4, 8, and 12 | The Revised FM Impact Questionnaire is a 21-item self-administered questionnaire, based on symptoms reported within the preceding 7 days. The total score ranges from 0 to 100, with higher values indicating worse health status. |
| Secondary | The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subsc | At the weeks 4, 8, and 12 | The BPI-S assesses pain intensity over the past 24 hours, including 4 items. The BPI-I evaluates the degree to which pain interferes with daily activities, comprising 7 items. Each BPI item is rated on a 0 to 10 NRS, with 0 represents no pain or does not interfere, and 10 represents worst pain imaginable or interferes completely. Higher scores indicate greater pain severity or interfere. |
| Secondary | The short-form 36 Health Survey (SF-36) | At the weeks 4, 8, and 12 | The SF-36 assesses health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status. |
| Secondary | Patient Global Impression of Change Scale | at week 12 | A 7-point patient-reported Likert scale for evaluating subjective overall change in health/symptoms from baseline, used to assess treatment efficacy in clinical research and practice. |
| Secondary | The Medical Outcomes Study Sleep Scale (MOS) | At the weeks 4, 8, and 12 | The MOS uses a 6-point scale to evaluate various dimensions of sleep, consisting of 12 items. A score of 1 indicates persistent presence, with a score of 6 denotes complete absence. |
| Secondary | The Beck Depression Inventory-Ⅱ (BD-Ⅱ) | At the weeks 4, 8, and 12 | The BD-Ⅱ employs a 4-point scale (ranging from 0 to 3) to evaluate the severity of depressive symptoms, comprising 21 items in total. A score of 0 indicates the absence of symptoms, while a score of 3 reflects severe symptomatology. |
| Secondary | Adverse Events | Through study completion, an average of 12 weeks | Adverse Events are defined as events that occur the course of treatment, were not present before prior to the intervention, or represent a worsening of pre-existing conditions. These events will be systematically documented and categorized by severity into grades such as mild, moderate, severe, or life-threatening. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT07196657/registered