Trial · NCT07196657
The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia
NCT07196657, Not applicable, Recruiting, Beijing Tiantan Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia. Trials, record NCT07196657. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07196657
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia
- NCT number
- NCT07196657
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 1,116 participants, estimated
- Lead sponsor
- Beijing Tiantan Hospital
- Conditions
- Fibromyalgia, Pregabalin, Pain
- Interventions
- Pregabalin, Crisugabalin
- First posted
- 2025-09-29
- Last updated
- 2026-02-11
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41800444 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07196657
GET https://conductscience.org/api/trials/v1/NCT07196657/registered